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Summary Internal Title: Expert Science & Technology Location: East Hanover, NJ, United States (On-Site) This position will be located at East Hanover site and will not have the ability to be located remotely. We are seeking a highly skilled and driven Expert Science & Technology in Product Sciences to join our team in advancing transformative cell therapy products. Reporting to the Director of Product Sciences, this role focuses on driving product characterization efforts, incorporating immunological principles, and developing innovative scientific approaches to solve complex challenges in the cell therapy space. As a bench scientist, you will leverage your expertise in immunology, cell biology, and advanced analytical methods to generate actionable insights and support the development of safe and efficacious cell therapy products that meet our target profiles. This role requires hands-on work in a fast-paced environment, applying scientific rigor and industry knowledge to enable data-driven decision-making. About the Role Key Responsibilities: <ul><li>Develop and refine advanced product characterization methods to assess quality attributes of cell therapy products, intermediates and starting material.</li><li>Design and execute innovative assays to assess T cell function, lineage, cytokine production, proliferation, cytotoxicity, memory composition, differentiation, exhaustion, metabolic profiling, and omics profiling. Qualify appropriate assay parameters to ensure characterization assays are fit for purpose.</li><li>Apply critical thinking skills to identify the right scientific questions aligned with product development goals. Independently design and execute experiments to address foundational and applied questions, leveraging immunological principles and cell therapy expertise.</li><li>Ensure effective data collection, management, and analysis to drive data-driven decision-making processes. Support regulatory filing by providing high-quality data, technical reports, and scientific rationale.</li><li>Collaborate with teams across Analytical Development, Process Development, Regulatory CMC, Biostatistics and Data Sciences to drive cell therapy programs forward.</li><li>Share scientific knowledge and assay development expertise to inform decisions on attribute criticality, specification setting, and control strategies.</li><li>Stay up to date on advances within immunology, cell therapy sciences, and analytical technologies.</li><li>Work proactively (i.e. using statistical methodologies) to address challenges in manufacturing success and clinical outcomes through product and process understanding.</li></ul> Requirements: <ul><li>Ph.D. in a relevant scientific discipline.</li><li>Minimum of 2 years of hands-on experience in developing T-cell characterization assays. Experience gained during the Ph.D. program can be counted toward this requirement.</li><li> Applicants must demonstrate a strong track record of bench-level assay development. </li><li> Deep knowledge of T cell biology and immunology. Familiarity with advanced analytical techniques such as flow cytometry, cell-based assays, ELISA, q/dPCR, Omics, imaging cytometry, and multiplex technologies. </li><li> Strong scientific problem solving and trouble shooting skills in a fast-paced environment. </li><li> Exceptional communications, scientific writing, and presentation skills. </li></ul> Desirable Requirements: <ul><li>Practical experience in statistics.</li></ul> The salary for this position is expected to range between $9 3,800.00 and $174,200.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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Expert, Product Sciences - Cell Therapy Analytical Development

Summary Internal Title: Senior Expert Science & Technology Location: East Hanover, NJ, United States (On-Site) This position will be located at East Hanover site and will not have the ability to be located remotely. We are seeking a highly skilled and driven Senior Expert in Product Sciences to join our team in advancing transformative cell therapy products. Reporting to the Director of Product Sciences, this role focuses on driving product characterization efforts, incorporating immunological principles, and developing innovative scientific approaches to solve complex challenges in the cell therapy space. As a senior bench scientist, you will leverage your expertise in immunology, cell biology, and advanced analytical methods to generate actionable product insights and support the development of safe and efficacious cell therapy products that meet our target profiles. This role requires hands-on work in a fast-paced environment, applying scientific rigor and industry knowledge to enable data-driven decision-making. About the Role Key Responsibilities : <ul><li>Develop and refine advanced product characterization methods to assess quality attributes of cell therapy products, intermediates and starting material.</li><li>Design and execute innovative assays to assess T cell function, lineage, cytokine production, proliferation, cytotoxicity, memory composition, differentiation, exhaustion, metabolic profiling, and omics profiling. Qualify appropriate assay parameters to ensure characterization assays are fit for purpose.</li><li>Apply critical thinking skills to identify the right scientific questions aligned with product development goals. Independently design and execute experiments to address foundational and applied questions, leveraging immunological principles and cell therapy expertise.</li><li>Ensure effective data collection, management, and analysis to drive data-driven decision-making processes. Support regulatory filing by providing high-quality data, technical reports, and scientific rationale.</li><li>Collaborate with teams across Analytical Development, Process Development, Regulatory CMC, Biostatistics and Data Sciences to drive cell therapy programs forward.</li><li>Share scientific knowledge and assay development expertise to inform decisions on attribute criticality, specification setting, and control strategies.</li><li>Stay up to date on advances within immunology, cell therapy sciences, and analytical technologies.</li><li>Work proactively (i.e. using statistical methodologies) to address challenges in manufacturing success and clinical outcomes through product and process understanding.</li></ul> Requirements: <ul><li> Ph.D. in Immunology, Cell Biology, or a relevant scientific field </li><li> A minimum of 5 years of post-educational, hands-on experience in developing T-cell characterization assays. Industry experience preferred. </li><li> Applicants must demonstrate a strong track record of bench-level assay development and product characterization in T cell-based therapies or similar therapeutic modalities. </li><li> Deep knowledge of T cell biology and immunology. Familiarity with advanced analytical techniques such as flow cytometry, cell-based assays, ELISA, q/dPCR, Omics, imaging cytometry, and multiplex technologies. </li><li> Strong problem solving and trouble shooting skills in a dynamic and fast-paced environment. </li><li> Exceptional communications, scientific writing, and presentation skills. </li></ul> Desirable Requirements: <ul><li>Practical experience in statistics</li><li>Experience contributing to regulatory filings (IND, BLA) with data packages related to cell therapy product characterization.</li></ul> The salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Sr. Expert, Product Sciences - Cell Therapy Analytical Development

Summary Designs & develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products' life cycle. Provides safety support to the clinical development teams. About the Role #LI-Hybrid Two roles available Key Responsibilities: <ul><li>Provides expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT) -Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.</li><li>Is responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources.</li><li>Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities.</li><li>Is responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues.</li><li>Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members -Contributes to and often leads the development of departmental and functional/business unit goals and objectives.</li><li>Distribution of marketing samples (where applicable)</li></ul>Key Performance Indicators: <ul><li>Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations & procedures -Compliance, consistency and quality of safety deliverables</li></ul>Essential Requirements: <ul><li>Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)</li><li>5 years clinical experience postdoctoral</li><li>At least 5 years progressive experience in drug development in a major pharmaceutical company, including 3 years in safety at a medical position</li><li>Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information - to include NDA submission documents</li><li>Strong experience in leading cross-functional, multicultural teams</li><li>Strong experience with (safety or others) issue management</li><li>Strong experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publication</li><li>Strong leadership skills including coaching, motivating, and directing, and fostering teamwork. Ability to develop and maintain effective working relationships with subordinates, superiors and peers</li></ul> The salary for this position is expected to range between $204,400 and $379,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Global Program Safety Lead

Summary In this individual contributor role, the Quality Control Scientist will support patient throughput and compliance activities within the Quality department. About the Role Number of positions open: 2 Shifts Available: Wed-Sat - Two PM positions open (3pm-3am) Location: Morris Plains, NJ Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you Major Accountabilities Patient Throughput<ul><li>Execute in-process and release testing on batches including, but not limited to, flow cytometry, IFNg potency, qPCR, cell count and viability, sterility, and endotoxin.</li><li>Perform data review, generate Certificates of Analyses for release of final produce in accordance with company procedure</li><li>Work with cross-functional stakeholders to meet company timelines</li></ul>Project Management<ul><li>Helps maintain progress of projects</li></ul>Compliance<ul><li>Ensures that all planned, executed, and documented activities are aligned with company and site objectives.</li><li>Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.</li></ul>Support of Quality partners<ul><li>Assists Quality Control, AS&T, and Quality Assurance in investigations of assay-related issues.</li><li>Executes and supports transfer of analytical methods between APS-QC, to other Novartis sites, and to CMOs.</li><li>Provides timely response to requests for support of manufacturing deviations, investigations and change requests.</li></ul>Other<ul><li>Performs or supports other tasks related to Quality and site operations, as needed</li><li>Performs evaluation of new and existing analytical methods being transferred to or from the site by utilizing a risk-based approach.</li></ul>Key Performance Indicators <ul><li>Timely delivery on commitments and departmental KPIs</li><li>Timely responses and solutions to analytical issues</li><li>Compliance to all relevant company policies and guidelines</li></ul>Ideal Background Education: BA, or MS in biology, chemistry, biochemistry, microbiology or other related science. Languages: English Experience: <ul><li>Experience in Analytical Quality Control, method development, or a technical support function.</li><li>At least 3 years of experience.</li><li>Demonstrated knowledge and skills in multiple analytical techniques</li><li>Understanding of ICH and FDA/EMEA GMP requirements</li><li>Ability to prioritize and execute multiple tasks simultaneously under tight deadlines</li><li>Strong verbal and written technical communication skills</li><li>Strong interpersonal skill</li><li>Proficiency using MS Word, Excel, and MS project</li><li>Knowledge of cGMP, USP and FDA guidelines.</li><li>Knowledge of LIMS systems.</li><li>Knowledge of Quality Management Systems, such as Trackwise and 1QEM</li><li>Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations. </li><li>Detail-oriented with ability towards problem solving and solid decision-making abilities.</li><li>Strong written and verbal communication skills are essential.</li></ul>Competency Profile Specific Professional Competencies: Internal orientation<ul><li>Thorough understanding of cGMP requirements</li><li>Good communication and organizational skills</li><li>Ensure customer satisfaction and react to customer requests</li><li>Is seen as a competent team player</li><li>Independent</li><li>Results-driven and goal-oriented work ethic</li></ul>Others<ul><li>Strong ability to work independently and compliantly</li><li>Strong analysis and decision-making skills surrounding documentation</li><li>Pays attention to detail</li><li>Able to proof work and identify non-standard format or wording, and errors within documents</li><li>Able to communicate with their management as well as other departments. </li></ul> The pay range for this position at commencement of employment is expected to be between $85,400 and $158,600/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

QC Scientist - PM Shift

Summary The Bioprocess Engineer III/IV for Cell Expansion/Upstream is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the site. Perform manufacturing tasks according to schedule, ensuring products meet quality standards and comply with cGMP, safety, and environmental regulations. *The role level will be determined by years of relevant experience. The role is located on-site in our Durham, NC location. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. About the Role Responsibilities:<ul><li>Produces clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.</li><li>Works on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.</li><li>Mentors and provides hands-on training to newly hired Bioprocess Engineers.</li><li>Ensures cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed.</li><li>Participates in information requests for all FDA and internal audits of the manufacturing facilities/processes.</li><li>Maintains quality standards to meet cGMP requirements, CFR's, and internal company policies related to the manufacturing process.</li><li>Leads tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.</li><li>Looks for opportunities to implement operational excellence and continuous improvement.</li><li>Partners with Quality to ensure a quality and compliant manufacturing environment.</li><li>Supports leadership to meet information requirements for quality, compliance, and management reporting.</li></ul>Shift: This role is a 2-2-3 rotating shift schedule. 6am-6pm. Role Requirements: Bioprocess Engineer III:<ul><li>Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with minimum 4 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment.</li></ul> Or <ul><li>A minimum 6 years' experience in cGMP in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree.</li></ul> Or <ul><li>Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 3 years' experience in the manufacturing of Novartis Gene Therapies product;</li></ul>Bioprocess Engineer IV:<ul><li>Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field with 5 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment;</li></ul> Or <ul><li>A minimum 7 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree;</li></ul> Or <ul><li>Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 3+ years' experience in the manufacturing of Novartis Gene Therapies product.</li></ul>Requirements for both levels:<ul><li>Excellent oral and written communication skills. Strong technical writing ability.</li><li>Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence.</li><li>Ability to routinely lift over 35 lbs.</li></ul> The salary for this position is expected to range between: for Bioprocess Engineer III: $32.12 and $59.62 per hour; for Bioprocess Engineer IV: $37.02 and $68.75 per hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Bioprocess Engineer III/IV, Days (Upstream)

Summary The Access & Reimbursement Manager, NPS (Novartis Patient Support) Immunology is a field-based role and covers the following geography, but is not limited to Greater San Francisco area, Sacramento, Fresno and Reno Associate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border. The Access and Reimbursement Manager (ARM) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. The ARM will serve as the key contact and lead for access and reimbursement support-related matters and is responsible for being the local market access expert on payer policy coverage, multi-channel acquisition pathways, billing and coding, claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. Additionally, the ARM will continually need to demonstrate a keen ability to problem solve, analyze access and reimbursement issues and opportunities, and proactively communicate changes in the healthcare landscape. The ARM will partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ARM will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third-party affiliates). About the Role Major accountabilities: <ul><li>Interact within assigned accounts to support patient access within their therapeutic area product(s) providing proactive face-to-face education on product-specific programs to providers and staff in order to support integration of those programs into office processes and workflows.</li><li>Address customer questions for issues related to NPC policies on therapeutic area product ordering, payment, inventorying, and product returns & replacement in offices.</li><li>Work with key members of therapeutic area offices (e.g., providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products.</li><li>Ability to analyze problems and offer solutions. Understand specifics and support questions associated with payer policies (e.g., utilization management, denial, and appeals), drug acquisition and inventory management, and patient / practice reimbursement (e.g., Co-pay, administration, drug claims). Analyze account reimbursement issues & opportunities (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient pull-through.</li><li>Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments.</li><li>Accountable for standing up NVS-sponsored patient support programs to enable patients starting and staying on therapy (i.e., Co-pay).</li><li>Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed). &bull; Interface with Patient Support Center (hub) on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education. Review patient-specific information in cases where the site has specifically requested assistance and patient health information is available in resolving any issues or coverage challenges.</li><li>Collaborate with aligned cross-functional associates within NPC (see above) to share insights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement.</li><li>Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPPA and other privacy laws and regulations and internal Company compliance guidelines).</li><li> Buy and Bill Specific: </li><li>Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel.</li><li>Responsible for establishing preferred acquisition pathways. Educate on and support buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and decentralized acquisition, and use of alternative channels such as white bagging, clear bagging, brown bagging, and alternate sites of care for administration.</li><li>Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement.</li><li>Analyze reimbursement issues & opportunities, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams.</li><li>Accountable for engagement with non-prescribers, for example pharmacy, system leadership, financial counselors, office administrators, revenue cycle managers, etc.</li><li> What You'll Bring to the Role: Education: Bachelor's degree required; Advanced degree preferred. Essential Requirements: </li><li>Minimum three to five years' experience in public or private third-party Reimbursement arena or pharmaceutical industry in managed care, clinical support, or sales.</li><li>Experience with specialty pharmacy products acquired through Specialty Pharmacy networks or specialty distributors (buy and bill)</li><li>Experience with coding, billing and in office support programs</li><li>Prior account management experience or prior experience with complex accounts (Payer landscape, high patient volume, large systems)</li><li>Specialty pharmacy experience required (ability to teach an office the entire process from script to injection)</li><li>Establishing relationships within a practice by working closely with them to help remove Reimbursement barriers to specialty products for their patients</li><li>Knowledge of Centers of Medicare & Medicaid Services (CMS) policies and processes with expertise in Medicare Parts B and D (Medical and Pharmacy Benefit design and coverage policy) a plus</li><li>Knowledge of Managed Care, Government, and Federal payer sectors, as well as Integrated Delivery Network/Integrated Health Systems a plus</li><li>Ability to operate as a "team player" in collaborating with multiple sales representatives, sales leadership, and internal colleagues to reach common goals</li><li>Ability to travel and cover large multistate geography territories, at least 50% travel required, based on geography and territory / targeting make up.</li><li>Must live within assigned territory.</li><li>Superb knowledge of buy-and-bill reimbursement pathway.</li><li>Experience working with established injection networks.</li><li> Desirable Requirements: </li><li>Ability to manage multiple products</li><li>Excellent presentation skills</li><li>Advanced knowledge of medical insurance terminology</li><li>Strong teamwork abilities</li><li>Project management skills</li><li>Ability to work independently</li><li>Ability to manage expenses within allocated budgets</li><li>Good driving record</li><li>Ability to schedule individual work-related travel (air, hotel, rental car as needed)</li><li>Above average computer skills: PowerPoint, Excel, Word, CRM (Salesforce.com)</li><li>Understanding of patient privacy laws including HIPAA and similar state laws</li><li>Strong business acumen</li><li>Ability to travel and possess a valid driver's license to drive to assigned healthcare accounts, unless otherwise specified</li><li></li></ul>Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Access & Reimbursement Manager, Immunology - San Francisco, CA - REMOTE

Summary #LI-Hybrid Join Novartis' Breast and Women's Cancer Marketing Strategy team as an Associate Director, Marketing Strategy, where you will be responsible for defining the HCP marketing strategy in metastatic Breast Cancer, focused on Non-Personal Promotion. This individual will support the Marketing Director, including the delivery of key strategic analyses and outputs to inform customer experience planning and execution within the Integrated Marketing & Customer Experience, US Organization. This key role will report directly into the Director of Marketing Strategy, partnering closely with other strategic partners, to ensure that the HCP Marketing Strategy and concepts are effectively orchestrated into campaigns, tactics and experiences. The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If the associate is remote, all home office expenses and any travel/lodging to the East Hanover, NJ site for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 25% travel. About the Role Key Responsibilities: <ul><li>Work effectively with the Director Marketing Strategy, mBC to develop a cohesive and integrated brand marketing strategy and campaign grounded in customer insight for this launch brand</li><li>Establish brand-specific HCP domain expertise, and create engaging brand-centered content and concepts for adaption into personalized and tailored experiences</li><li>Share and embed knowledge on best practices across the Marketing Strategy IMO to engage HCPs and change behavior across the full brand lifecycle, improving impact and creating communities of practice on effective and impactful marketing.</li><li>Implement best in class digital marketing strategies that align to brand goals and maximize business results. </li><li>Ensure digital plans are appropriately implemented and optimized.</li><li>Identify, test, and validate creative concepts and messaging architecture; creating assets for HCPs.</li><li>Foster a high performing team that proactively and effectively interfaces across key functions to achieve the product strategies and objectives</li><li>Support and deliver an integrated plan for the brand to achieve the Product strategy and objectives; define resourcing required and managing the allocated budget for HCP/Patient, collaborating effectively across strategic partners including CXP&O, NPS, Access, Patient Advocacy, Customer Engagement, and Insights and Decision Sciences (IDS).</li><li>Drive excellence in developing the lead asset for HCP/Patient through domain expertise to enable adaptation across the end-end experience, partnering closely with the Customer Experience Planning and Optimization team (CXP&O).</li><li>Provide input and work closely with our HCP/Patient agency (AoR) for brand marketing and partner with Operations to maximize agency relationship(s).</li></ul>Essential Requirements:<ul><li>Bachelor's degree in related field is required; Master of Science and/or MBA preferred</li><li>Minimum of 5 years of experience in commercial marketing in pharmaceutical or healthcare</li><li>At least 3 years of demonstrated experience of leveraging data, analytics, and customer insights to drive personalization at scale in the US market</li><li>Oncology therapeutic area or specialty drug experience</li><li>Strong experience in digital, non-personal promotion, media, and social</li><li>Experience in supporting high performing brands in highly competitive categories within the US; recent launch experience for blockbuster specialty treatments preferred</li><li>Strong cross-functional leadership and ability to collaborate effectively with various stakeholders and teams including Product, Communications, Legal, Regulatory, Compliance and Global</li><li>Excellent written and oral communication skills with the ability to effectively communicate complex ideas and information to a range of audiences and stakeholders</li></ul>Desirable Requirements:<ul><li>Experience in digital strategies and capabilities development</li><li>Multi-functional experience in pharmaceuticals or healthcare</li></ul>Novartis Compensation Summary : The salary for this position is expected to range between $145,600 and $270,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

AD, Marketing Strategy - Breast/Women's Cancer - Non-Personal Promotion

Summary Onsite #LI-Onsite Cambridge, MA About the role: We are in search of a Principal or Senior Principal Biostatistician to join a passionate team in early phase drug development. Come to an industry leader where you will lead implementation of modern and innovative trial/experimental designs, statistical models, and analysis and data exploration methodologies at the study or project level, and you will be responsible for all statistical work, scientific and operational, in collaboration with the clinical trial teams and other quantitative partners in the Early Development - Advanced Quantitative Sciences team. About the Role About the role: We are in search of a Principal or Senior Principal Biostatistician to join a passionate team in early phase drug development. Come to an industry leader where you will lead implementation of modern and innovative trial/experimental designs, statistical models, and analysis and data exploration methodologies at the study or project level, and you will be responsible for all statistical work, scientific and operational, in collaboration with the clinical trial teams and other quantitative partners in the Early Development - Advanced Quantitative Sciences team. Your Key Responsibilities: <ul><li>Responsible for all statistical tasks on the assigned trials.</li><li>Protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities.</li><li>Contribute to planning and execution of statistical analyses and statistical consultation within your cross-functional teams.</li><li>Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.</li><li>Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight.</li><li>Collaborate cross-functionally (e.g., data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables.</li><li>Contribute to external engagement with consultants, advisory boards, health authorities, congresses, and scientific meetings.</li></ul>Video Link Meet the Data Analytics team This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. Role Requirements: Essential Requirements: <ul><li>Principal / Senior Principal level commensurate with experience. PhD with 3+ years experience or MS with 7+ years preferred.</li><li>Fluent English (oral and written).</li><li>Strong communication and presentation skills.</li></ul>Preferred Requirement:<ul><li>Previous experience in oncology research.</li></ul>Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $119,700 and $222,300/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Principal / Senior Principal Biostatistician

Summary The Study Start-Up (SSU) Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans. The Study Start-Up Lead works collaboratively with other key CTT members and leads the SSU Team (CTT sub-team) comprised of the country SSU Management, Vendor Management, Regulatory, Grants and Contracts, Translations, Document Management, Clinical Supplies, and others as needed to accelerate study, country, and site activation. The Study Start-Up (SSU) Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans. The Study Start-Up Lead works collaboratively with other key CTT members and leads the SSU Team (CTT sub-team) comprised of the country SSU Management, Vendor Management, Regulatory, Grants and Contracts, Translations, Document Management, Clinical Supplies, and others as needed to accelerate study, country, and site activation. #LI-Hybrid The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific East Hanover for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. About the Role Key Responsibilities: Early Planning and Team Leadership :<ul><li>Contributes SSU insights to the development of the trial Operational Execution Plan (OEP) and aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones and dashboards with Study Leader/Clinical Trial Team (CTT).</li><li>Configures and ensures proper trial-specific set-up of SSU systems (e.g., Expected Document Lists, eTMF, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.)</li><li>Prepares global SSU planning and leads SSU Team (CTT sub-team) from kick-off through completion of SSU (all countries and 95% sites enrolling or as defined per trial)</li><li>Implements global aspects of protocol and OEP amendments, activates and oversees country implementation of amendments as determined per trial and in conjunction with Study Leader.</li></ul> Leads Global SSU Activation: <ul><li>Ensures timely collection global trial level document readiness (including vendor and IMP (Investigational Medicinal Product) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation</li><li>Supports the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents</li><li>Ensures Protocol and ICF (Informed Consent Form) global trial template is ready for country usage as necessary including translations</li><li>Drives transparency of timelines of global SSU deliverables with SSU Managers to ensure country alignment and efficiency</li><li>Directs the Study Grants Expert for investigator grant plan/fair market value assessment initiation and finalization of country site budget and contract template readiness in conjunction with protocol timelines</li><li>Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness</li><li>Provide proactive oversight and risk management for SSU team activities to achieve start-up timelines and quality execution, proposing and implementing corrective actions where appropriate, according to Novartis standards and local and international regulations</li><li>Collaborates with GCS (Global Clinical Supply) to ensure coordination and readiness of global clinical supply</li><li>Ensures proper hand-off of activities applicable to the Study Leader and other roles as necessary</li><li>Ensures the use and date completeness/accuracy of applicable technology platforms during SSU</li></ul> Accountable for Country SSU: <ul><li>Enables country Study Start-up Managers to drive timely start-up activities from country allocation to Ready to Enroll" within assigned trial</li><li>Provides oversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to plan, including set-up and usage of tools/systems, timely delivery of SSU deliverables (e.g. IRB/IEC submission packages, Informed Consent review, local submission package for submission to IRB/IEC,CTA (Clinical Trial Application)Hub (Europe: acc. to new EU-CTR)as well as Health Authorities and adherence to process standards.</li><li>Supports the VPM as needed to ensure global vendor activation and site readiness in collaboration with to meet site activation timelines/plan.</li><li>Ensure global deliverables to enable site initiation readiness is in place for initial drug release</li><li>Ensures global and country budget (TCF (Trial Commitment Forms)) processes and approvals support SSU activities and timelines</li></ul> Role Requirements :<ul><li>A degree in scientific or health discipline, with a preference for an advanced degree with clinical trial and/or project management experience</li><li>Minimum 2 years' experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials</li><li>Minimum 1 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization</li><li>Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations.</li><li>Excellent English communication, influencing and negotiating skills</li><li>Good knowledge of Good Clinical Practice, clinical trial set-up design and global drug development process</li><li>Demonstrated effective influencing and negotiation skills at all levels.</li><li>Data and Digital expertise. Experience working with electronic databases, clinical and/or project management planning and reporting and analytics systems</li><li>Data and timeline driven, Willingness and ability to champion the use of new technology</li></ul>The salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Study Start-Up Lead

Summary #LI-Hybrid The Director, Marketing Strategy will lead the marketing efforts for the Immunology pipeline and brand within the Novartis US Integrated Marketing Strategy team. This role involves defining the marketing strategy and supporting enablement initiatives while collaborating with various cross-functional teams. Reporting to the Executive Director, Senior Marketing Strategist, this individual will work closely with the Integrated Marketing Strategy Leadership Team and other partners to create and execute robust, insight-based marketing strategies and campaigns. The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover, NJ for periodic live meetings will be at the employee's expense. This position will require 20% travel; the expectation of working hours and travel (domestic and/or international) is defined by the hiring manager. About the Role Key Responsibilities:<ul><li>Collaborate with the Marketing Strategy Lead and stakeholders to create unified marketing strategies, brand platforms, and campaigns based on customer insights and data analysis.</li><li>Develop engaging content and concepts for personalized experiences</li><li>Foster a high performing team that proactively and effectively interfaces across key functions to achieve the brand platform strategies and objectives</li><li>Define and deliver the brand platform integrated plan to achieve the strategy and objectives; define resourcing required and manage the allocated budget</li><li>Drive excellence in developing assets to enable adaptation across the end-end experience, partnering closely with the Customer Experience Planning team</li><li>Drive best in class digital marketing strategies that align to goals and maximize business results and ensure digital plans are appropriately implemented and optimized.</li><li>Collaborate with Product Strategy and Global / IMI teams on integrated strategy, plan, and asset(s), as appropriate</li></ul>Essential requirements:<ul><li>Education: Bachelor's degree in a related field is required; Master of Science, and/or MBA preferred</li><li>Minimum of 7 years in commercial marketing with experience in driving high performing brands in highly competitive categories within the US</li><li>Minimum of 5 years of demonstrated experience of leveraging data, analytics, and customer insights to drive personalization at scale</li><li>Demonstrated ability to build strong business collaborative relationships with various stakeholders and work effectively on a team</li><li>Transformational Leader with strategic experiences to transform the business into next generation engagement</li><li>Strong understanding of AI and Interactive Experiences</li><li>Ability to develop and deliver resources/programs/tactics on time, on scope, on budget, with strong financial acumen</li><li>Skilled at navigating complex platforms and brands </li><li>Ability to translate in market data signals to actions</li></ul> Desirable requirements: <ul><li>Multi-functional experience in consumer-packaged goods, pharmaceuticals or healthcare</li><li>Launch experience for immunology, oncology, or neuroscience and adept in understanding behavioral science</li></ul>Novartis Compensation Summary: The salary for this position is expected to range between $185,500 and $344,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Director, Marketing Strategy - Immunology

Summary This position will be located at the Cambridge, MA or East Hanover, NJ location and will not have the ability to be located remotely. This is 1 of 2 positions. About the Role The Insights and Decision Science (IDS) team is dedicated to enabling improved decision - making at Novartis by leveraging data and advanced analytics capabilities to generate actionable insights that drive business growth. We collaborate closely with the US business, bringing insights and challenging ideas to empower smarter, data-driven decision-making. Reporting into the Executive Director , Emerging Data Product s , this role is crucial in driving the transform ation of patient care by leveraging advanced data analytics and innovative methodologies to uncover opportunities for growth and optimize treatment strategies . The Director will lead cross-functional teams to deliver innovative data solutions, leveraging advanced analytics and cutting-edge technologies to generate actionable insights. By fostering a culture of collaboration and innovation, this role will enhance Novartis' ability to make data-driven decisions and maintain a competitive edge in the pharmaceutical industry. Key Responsibilities:<ul><li> Develop and articulate a clear vision for data product innovation that aligns with Novartis' strategic objectives . </li></ul><ul><li> Oversee and implement novel concepts that enhance business outcomes through emerging technologies, advanced data collection, data engineering, and AI-driven insights. </li></ul><ul><li> Drive the adoption of cutting-edge technologies to transform patient care and uncover new growth opportunities. </li></ul><ul><li> Execute a comprehensive product roadmap for emerging solutions, ensuring alignment with business needs, market trends, and evolving technological capabilities. </li></ul><ul><li> Actively manage the product backlog, prioritizing initiatives that provide the highest strategic value and scalability. </li></ul><ul><li> Ensure continuous improvement and adaptability in response to changing market conditions and business needs. </li></ul><ul><li> Ensure smooth onboarding, training, and communication for stakeholders using new technologies and solutions. </li></ul>Essential Requirements: Novartis is seeking an experienced and dynamic leader to drive patient finding initiatives, leveraging data analytics and insights to identify underdiagnosed or untreated patient populations. The ideal candidate will possess a deep understanding of the pharmaceutical landscape, with expertise in applying advanced methodologies from varied data sources to uncover patient growth opportunities and optimize treatment strategies. This role requires a leader who excels in fostering collaboration across cross-functional teams, developing talent, and cultivating a culture of innovation. The ED will establish a robust framework for delivering actionable insights through secondary data analytics, empowering strategic initiatives and enhancing patient care. Education: Bachelor's degree in related field is required ; Master of Science and/or MBA strongly preferred <ul><li> Minimum of 10+ years of experience in the pharmaceutical or healthcare industry, with a strong focus on data analytics , patient identification and strategic insights. </li></ul><ul><li> Proven track record of leading data-driven decision-making at a senior leadership level. </li></ul><ul><li> Expertise in claims/EHR analytics, AI/ML, and strategic analytics. </li></ul><ul><li> Minimum of 5+ years of people management experience, with a focus on developing talent and fostering a culture of innovation. </li></ul><ul><li> Strong analytical and strategic thinking skills, with the ability to translate complex data into actionable insights. </li></ul><ul><li> Excellent communication and collaboration skills, capable of influencing and engaging with leadership across functions. </li></ul><ul><li> Experience in leading cross-functional and matrixed teams, with demonstrated ability to maintain flexible collaboration with diverse teams including internal IPST/TA teams and external partners to meet strategic objectives </li></ul><ul><li> Ability to thrive in a fast-paced, dynamic environment and adapt to changing business needs and priorities </li></ul>Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $168,000.00 and $312,000.00/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Dir, Data Products Owner

Summary "We're a team of dedicated and smart people united by a drive to achieve together" Are you passionate about shaping the future of clinical development and making a meaningful impact in Cardiovascular medicine? We are looking for an experienced and visionary Clinical Development Medical Director (CDMD) to take the lead in driving the strategic planning and execution of our cutting-edge clinical programs with a focus on anticoagulation. In this pivotal role, you will oversee the end-to-end clinical development process for assigned programs within the Cardiovascular Therapeutic Area. Your expertise and leadership will ensure the seamless execution of clinical development plans while fostering a culture of empowerment, agility, and collaboration within a dynamic matrixed environment. If you thrive in a fast-paced, purpose-driven organization and have the skills to adapt swiftly to evolving business needs, we would love to have you on board! About the Role Major Accountabilities <ul><li>Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program</li><li>Leading development of clinical sections of trial and program level regulatory documents</li><li>Driving execution of the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable</li><li>Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues</li><li>Supporting the Clinical Development Head (CDH) and GPCH by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas</li><li>As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards</li></ul>. Required Experience Essential<ul><li>MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in disease area preferred</li><li>Extensive experience in clinical research or drug development</li><li>Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.</li><li>Experience of contributing to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.</li><li>Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports</li><li>Demonstrated ability to establish effective scientific partnerships with key stakeholders</li><li>Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes</li><li>Previous global people management experience is preferred, though this may include management in a matrix environment.</li></ul> The salary for this position is expected to range between $236,400 and $439,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Clinical Development Medical Director - Cardiovascular

Summary The Warehouse & Aph / FP Manager is responsible for leading, organizing, sustaining, and continuously improving the warehouse and the Apheresis / Final Pack operations in support of the manufacturing activities at the plant. This individual will work to ensure materials and products are received, stored, delivered, and shipped in a safe, compliant and efficient manner. This position will be responsible for all material handling and storage at the plant and the Apheresis receipt and the Final Pack shipments. About the Role Responsibilities:<ul><li>Manage and lead the day-to-day Warehouse and APH/Pack team operations and personnel, across all shifts, 24 hours per day x 7 days per week.</li><li>Support manufacturing operations with timely delivery of all required materials in accordance with the manufacturing schedule.</li><li>Ensure cGMP documentation is filled out correctly, training for all team members is current, and all Quality requirements are being followed. Lead or participate in tours or information requests for all Regulatory and internal audits and respond to any observations received per procedure.</li><li>Ensure that the teams are adhering to quality standards that comply with all cGMP requirements, CFR's, and internal company policies and SOPs, related to Warehouse and APH/Pack operations.</li><li>Proactively looks for opportunities to implement operational excellence and continuous improvement.</li><li>Partner with Quality and Safety to ensure a high quality,compliant and safe operation. Support Director Supply Chain to meet information requirements as needed for quality, compliance, and management reporting.</li><li>Ensure compliance with federal, state, and local requirements for warehousing, material handling, and shipping by staying abreast of existing and new legislation.</li><li>Ensure material availability by managing inventory accuracy and levels through physical counts and reconciling with ERP system.</li><li>Plans and coordinates work schedules for personnel to ensure the proper staffing levels and shift structure is in place to support processes across all shifts for the Warehouse and APH/Pack teams.</li><li>Responsible for hiring, training, and evaluating the performance of Associates, and for developing supervisors to effectively oversee the daily responsibilities of their assigned team members.</li><li>Ensures the teams achieve Operational targets for Quality, Safety and Cost efficiency </li></ul>Requirements:<ul><li>B.S. degree in supply chain, engineering, science, business or related field.</li><li>A minimum of 3-5 years of experience in biopharmaceutical based GMP manufacturing operation including direct experience receiving, shipping and warehousing.</li><li>1-3+ years of supervisory experience with demonstrated effectiveness in providing input, guidance, mentorship and support to staff.</li><li>Working knowledge of FDA regulations and cGMP practices.</li><li>Excellent oral and written communication skills with strong technical writing ability required.</li><li>Ability to motivate staff and influence peers, foster a culture of continuous improvement and operational excellence.</li><li>Experience with 3rd parties (material suppliers, equipment suppliers, contract manufacturing partners, etc.).</li><li>Project management skill set with experience in strategic/tactical planning, team building, and overall budget requirements. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.</li></ul>Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $103,600 and $192,400 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You'll Receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Manager, Warehouse & Aph/FP  - Cell Therapies

Summary #LI-Onsite The Bioprocess Engineer II/III for Cell Expansion/Upstream is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the site. Perform manufacturing tasks according to schedule, ensuring products meet quality standards and comply with cGMP, safety, and environmental regulations. *The role level will be determined by years of relevant experience. The role is located on-site in our Durham, NC location. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. About the Role Responsibilities:<ul><li>Produces clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.</li><li>Works on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.</li><li>Ensures cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed.</li><li>Participates in information requests for all FDA and internal audits of the manufacturing facilities/processes.</li><li>Maintains quality standards to meet cGMP requirements, CFR's, and internal company policies related to the manufacturing process.</li><li>Supports tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.</li><li>Looks for opportunities to implement operational excellence and continuous improvement.</li><li>Partners with Quality to ensure a quality and compliant manufacturing environment.</li><li>Supports leadership to meet information requirements for quality, compliance, and management reporting.</li></ul>Shift: This role is a 2-2-3 rotating shift schedule. 6pm-6am. Role Requirements: Bioprocess Engineer II:<ul><li>Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with minimum 2 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment.</li></ul> Or <ul><li>A minimum 4 years' experience in cGMP in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree.</li></ul> Or <ul><li>Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 1 year experience in the manufacture of Novartis Gene Therapies product;</li></ul>Bioprocess Engineer III:<ul><li>Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with minimum 4 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment.</li></ul> Or <ul><li>A minimum 6 years' experience in cGMP in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree.</li></ul> Or <ul><li>Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 3 year experience in the manufacture of Novartis Gene Therapies product;</li></ul>Requirements for both levels:<ul><li>Excellent oral and written communication skills. Strong technical writing ability.</li><li>Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence.</li><li>Ability to routinely lift over 35 lbs.</li></ul> The salary for this position is expected to range between $32.12 and $59.62 per hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Bioprocess Engineer II / III, Nights (Upstream)

Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals. The Supervisor, Maintenance and Calibration is responsible for oversight and leadership of all maintenance and calibration activities support for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. They will lead a team of site-based technicians to establish, maintain and improve site maintenance and calibration programs and activities. Responsible for reliable, efficient and sustained operation of the facility and all equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area. About the Role Major accountabilities: &bull; Manages team of maintenance and calibrations technicians to support manufacturing continuously, efficiently, and effectively through corrective and preventative maintenance activities. &bull; Ensures equipment operates to required HSE, Quality, Environmental and Reliability standards &bull; Contribute to equipment, utility, facility improvement projects (e.g. energy efficiency, productivity, environmental compliance &bull; Support continuous improvement of the maintenance and calibration program &bull; Support internal and external audits &bull; Act as maintenance/calibration SME in relation to new initiatives and special projects &bull; Enter master data into CMMS (e.g. confirmation and technician time allocations) &bull; Establish vendor contracts, project engineering & control and identify technical solutions &bull; Work with maintenance planner to coordinate and plan maintenance / calibration activities &bull; Perform a wide range of maintenance repair activities on production equipment, central utilities systems, environmental monitoring systems, and building management systems. &bull; Assist in troubleshooting and repair of various systems (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision. &bull; Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. &bull; Write/revise training documents and maintenance procedures for various production and utility systems. &bull; Completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System &bull; Supply information and technical data for securing spare parts. &bull; Provide responsive customer support with emphasis on customer satisfaction. &bull; Support startup and commissioning activities with an emphasis on maintenance and calibration development. (Sensor Risk Assessments, Work Plans, FMECA) &bull; Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs &bull; Own or support change controls related to maintenance and calibration &bull; Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment. &bull; Complete and provide accurate documentation, as required in cGMP operations. &bull; Oversee work and provide training of less experienced maintenance technicians and/or new technicians. &bull; Other related duties as assigned. &bull; Use of CMMS system for documentation of relevant work. The salary for this position is expected to range between $93,800 and $174,200 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements: &bull;High School diploma or equivalent is required; Bachelor's Degree is preferred. &bull; 5+ years of experience in a maintenance or calibration related field &bull;Previous supervisory, team/project lead experience is required. &bull; Self-motivated with a strong sense of ownership in areas of responsibility. &bull; Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere. &bull; Demonstrated ability to work and collaborate on cross functional teams (QE, QA, validation, operations) in a fast paced, dynamic team setting. &bull; Strong interpersonal and excellent verbal and written communication skills are essential. &bull; Planning, problem analysis, and decision-making skills. &bull; Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS). &bull; Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.) &bull; Experience in operating and maintaining mechanical systems in a cGMP or other regulated environment. &bull; Ability to climb ladders and lift up to 50 lbs. &bull; Must be flexible to work nights, weekends, and holidays as required. Desirable requirements: &bull; 3+ years pharmaceutical based GMP manufacturing operations including aseptic fill/finish and/or radio pharmacy (preferred) &bull; Experience working with/around radioactive material (preferred) &bull; Radiation safety education (preferred) Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Maintenance and Calibration Supervisor

Summary About this role: Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems for the Indianapolis manufacturing site. Location: Indianapolis #LI-Onsite Must be flexible with schedule &bull;Shift Hours: Weekday Night shift from 2PM to 2 AM. &bull;Work Schedule: Rotating workweek with a mix of 4-day and 3-day work periods. Schedule Breakdown: &bull;Week 1: Work Monday to Thursday (4 days), then have 3 days off (Friday to Sunday). &bull;Week 2: Work Monday to Wednesday (3 days), then have 4 days off (Thursday to Sunday). About the Role Key Responsibilities:<ul><li>Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.</li><li>Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.</li><li>Assist functional areas with achieving timely and compliant final product disposition of the product.</li><li>Review, approve and support procedures and production/testing records as required and assist in the training of site associates.</li><li>Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.</li><li>Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.</li><li>Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.</li><li>Other related duties as assigned.</li></ul>Essential Requirements<ul><li> Bachelors' Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 3-5 years in a role within pharma industry that includes quality assurance experience will be considered </li><li> 2+ years of experience in a GxP Biopharmaceutical manufacturing operations </li><li>1+ years of experience in a quality assurance role</li><li>Cross functional collaboration</li><li>QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired</li><li>Proven track record and practical experience with cGMP requirements</li><li> Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. </li></ul> The salary for this position is expected to range between $81,200 and $150,800/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

QA Operations Specialist

Summary The Manager, Tax Technology and Transformation is responsible for supporting all aspects of the tax function including domestic and international tax processes. This role will help drive current and future technology initiatives and automation across operational processes. In addition, this role will also support the tax function in compliance and planning activities when needed. The person will be key in driving the strategic direction of an inclusive, globally integrated, finance based and functionally connected US tax organization, covering end-to-end all relevant aspects of US tax. This role is required to be in our East Hanover, NJ office 3x/week. Please only apply if this works for you. About the Role Key Responsibilities: Leading Tax <ul><li>Lead the design, integration and implementation of technology and data management solutions to automate, streamline, standardize and support data and process requirements for US tax including tax accounting and compliance, transfer pricing, tax planning and controversy.</li><li>Collaborate with Tax, Finance, IT and other internal and external stakeholders in defining and documenting processes (current and future state), system, technical and functional requirements and design specifications to maximize process efficiency, increase quality and governance support and optimize effectiveness in meeting tax reporting and compliance obligations.</li><li>Lead the US tax effort and maximize the value delivered in support of federal and state tax reporting, compliance, and controversy, and act as trusted and respected advisor with stakeholders and senior management</li><li>Provide leadership and technical support as a function aligned with tax provision, tax planning and transfer pricing based on strong finance and accounting skills, promoter of the strategic integration of US Tax into the local and global Novartis organization including business partnering and technical expertise on all dimensions of tax reporting</li><li>Representative of US tax function with policy makers, fiscal authorities, industry associations, tax director community and other external stakeholders to front Novartis on specific tax matters</li></ul>Planning, Compliance and Risk Management<ul><li>Oversee tax systems architecture including project management, development support and production support.</li><li>Ensure design and implementation of the control framework (i.e. SOX) meets governance requirements.</li><li>Lead the implementation and management of intelligent automation tools and solutions, including data transformation and visualization tools and ONESOURCE Income Tax and Tax Provision.</li><li>Administer user access rights, manage periodic updates/upgrades, and provide oversight, problem-solving and technical support for tax technology applications.</li><li>Monitor and keep current on emerging tax technology trends, software tools and continually reevaluate and revise the tax technology strategy to ensure optimal results.</li><li>Develop system/process documentation and deliver end-user training; document policies and procedures for the efficient and effective use of tax technology and information systems.</li><li>Ensure the contemporaneous availability of financial and tax data (P/L and B/S) on all dimensions of IFRS and tax for tax reporting and compliance and audit preparedness</li><li>Support in pro-actively monitoring and developing tax reporting and compliance processes and technology with the aim to achieve simplification and standardization and improve operational effectiveness and efficiency. Ensure clear roles and responsibilities, the maintenance of local guidelines/work instructions in order to properly manage tax processes in coordination with relevant stakeholders.</li></ul>People and Development<ul><li>Encourage an environment of collaboration and professional development, create a sense of empowerment, teamwork and ownership to elevate the US tax team to a knowledge center covering all US tax areas and pro-actively interconnected within US Tax and with US and global stakeholders (HQ Tax, Global FRA, M&A, finance, treasury, funds flow, BR, Development, commercial, legal, etc.)</li><li>Act as a role model and mentor to the US Tax team members, embracing business partnering, knowledge sharing and technical excellence at the crossroads of tax, finance/accounting, and legal</li><li>Ensure training and development opportunities for team members and stakeholders</li><li>Active member of the global tax function driving the strategy, priorities, initiatives, and activities of the global tax function, in close collaboration with business and finance stakeholders</li></ul>Key Performance Indicators<ul><li>Successful execution in all tax aspects of global and local initiatives and projects</li><li>Contribution to US and Group ETR through pro-active, recognized US tax practice closely connected with US and global stakeholders</li><li>Impact on US tax team members through role model, mentoring and technical savviness</li></ul>Essential Requirements:<ul><li>Finance/Accounting degree, with preferred further accredited accounting and/or tax qualification (e.g. CPA, Masters of Tax)</li><li>Minimum of 5+ years of US Tax experience in Big 4 and/or corporate department of a large publicly held multinational company </li><li>Experience with the ONESOURCE suite of tools, Alteryx, Dataiku, PowerBI, PowerQuery, and AI modeling</li></ul>Benefits & Rewards The salary for this position is expected to range between $98,700 and $183,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Manager, Tax Technology and Transformation

Summary Location: Cambridge, MA, (Hybrid) #LI-Hybrid This role will be based out of Cambridge, MA. The role will be based on site 3-4 days/week. Job Purpose The US People and Organization (P&O) team is seeking a new People Partner to support BR, Novartis Biomedical Research organization. Our People Partners act as a trusted advisors offering in-country policy expertise and knowledge to support and educate leaders, managers and associates on all People and Organization (P&O) topics on the moments that matter. People Partners support divisional customer groups in country enabling the delivery of lifecycle events, the employee value proposition, talent acquisition, talent management, learning, performance management, employee relations, rewards, pay and reporting. In addition, People Partners implement P&O change initiatives at a country level acting as agents of change by working collaboratively with Business Partners and Senior People Partners. We work collaboratively across divisions and adapt our support to meet the evolving needs of the business. About the Role Major Accountabilities:<ul><li>Accountable for credible P&O People Partnering to leaders, managers and associates, offering advice and guidance on the moments that matter.</li><li>Analyzes relevant data and metrics to understand and anticipate annual workload trends to ensure the team has capacity to meet business needs.</li><li>Champions culture and supports implementation of corporate initiatives. Clarify People Partner team priorities linked to purpose and strategy, helping collaborate with other teams, manage across the matrix, remove obstacles and overcome silos. Collaborates with other P&O People Partner Heads in other countries, regions and clusters to maintain a consistent standard globally.</li><li>First point of escalation for all leaders and managers on their day-to-day P&O topics, providing expert advice, guidance and support. Acts as the escalation point for exceptions to P&O standards (regulations and P&O processes), deviations or appeals.</li><li>Drive buy-in and utilization of data and analytics to identify risk and trends, and to apply these business insights to inform decisions and actions. Drives quality, effectiveness, efficiency and continuous improvement for P&O People Partnering and related processes. Embraces customer feedback to understand the customer journey with moments that matter and drives continuous improvement.</li><li>Ensure compliance with local equity / Equal Employment Opportunity (EEO) regulations.</li><li>Leads the People Partner team to ensure successful country transitions and integrations including effective change management and business continuity ; Lead the delivery of in-country transformations, consult and negotiate with local works council / unions, provide advice and guidance for managers through the local process, oversee associate notice / handover meetings and overall restructuring lifecycle.</li><li>Leads alignment and harmonization of local regulations with P&O Board; monitors compliance, risk management and review P&O controls (as part of the NFCM framework) working with People Partner team.</li><li>Provides coaching and counselling to Country P&O Business Partners on local policies and processes. Lead career and development conversations; understand team aspirations, skills and the capabilities required for success. Identify required critical capabilities for the future and establish plans to meet capability gaps at the organization and individual level.</li></ul>What you will bring to the role; <ul><li>BA Degree in a relevant HR or related discipline.</li><li>At minimum 7+ years' work experience in P&O - with breadth of experience across P&O disciplines. At minimum 3+ years supporting a complex and metrics organization within the US. A good understanding of global organizations will be an advantage.</li><li>Strong Interpersonal skills; Proactive, responsive and ability to work independently with all levels of the organization. Ability to handle multiple conflicting tasks in a fast-paced environment is a must. Stakeholder Management and ability to collaborate across boundaries.</li><li>Coaching and Mentoring; proficient in facilitation, influencing and collaborating across boundaries. Strong Project management capabilities and people analytics skills, effectiveness with data / metrics / reporting to inform decision making. Employee relations, Risk management and Change management expertise.</li><li>Fluency in English both oral and written communication skills.</li><li>Experience working in a variety of organizations country wide.</li></ul> The salary for this position is expected to range between $ 126,000 and $ 234,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Senior People Partner

Summary The Specialist, Clinical Manufacturing, is responsible for providing project support and direct Manufacturing execution support for new product introductions. This includes technical writing skills to author new documents and translate from existing tech transfer documents. This role will work cross functionally with the Manufacturing, MSAT, Engineering and TRD groups in order to bring clinical manufacturing programs into the facility. About the Role This position will be located in Durham, NC. This person is required to be onsite the majority of the time and must be on-site during production runs . Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities:<ul><li>Authors and manages master manufacturing documents of assigned products (e.g. Master Batch Record, Standard Operating Procedure, Bill of Material (BOM), and Recipe, Quality Risk Assessment, Hazard Analysis).</li><li>Implementation and delivery of new Clinical products into the facility.</li><li>Provide direct hands-on front-line support to manufacturing.</li><li>Executes batch activities with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.</li><li>Supports technology transfer projects, to include new product change controls for the introduction of clinical production at the site.</li><li>Manages projects to implement significant changes to Clinical manufacturing processes.</li><li>Supports the PMO group for any technology transfer activities.</li><li>Maintains quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process.</li><li>Supports Deviation/CAPA team.</li><li>Support internal and external audits for group owned processes.</li><li>Other related duties as assigned.</li></ul>Requirements:<ul><li>B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations.</li><li>Strong technical writing ability required, specifically experience writing SOPs and Batch Records.</li><li>Experience in technology transfer of biotechnology candidate clinical products and/or technology transfer of commercial products from site to site. Cell and/or Gene therapy, large molecule or biologics is a plus. </li><li>In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility.</li><li>Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products are preferred.</li><li>Excellent oral and written communication skills.</li><li>Travel as required to other internal sites, vendors, and CMOs as required ( </li></ul>Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $81,200 and $150,800/year ; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Specialist, Clinical Manufacturing

Summary #LI-Hybrid This position will be on-site in Cambridge, MA or East Hanover, NJ and will not have the ability to be located remotely. In the Associate Director in PK Sciences you will provide ADME /PK/PKPD project support to the Neuroscience Therapeutic Area contributing to projects from Discovery to IND filing and First-in-Human studies and beyond. In this unique role you will collaborate and partner with PK Sciences functions including in vitro and in vivo ADME, biotransformation, bioanalytics and modeling & simulation and represent the PK Sciences organization within project teams. About the Role Key Responsibilities: <ul><li>Support teams in developing the strategy for, and coordinate the implementation of, the characterization and selection of lead compounds and drug candidates with favorable PK/ADME properties, elucidate PK/PD relationships driving efficacy/safety and contribute to human PK prediction and dose and regimen selection. </li><li> Provide matrixed leadership across the organization to align and influence across the cross-functional team to identify and mitigate key project issues related to the pharmacokinetic sciences [PKS] discipline (PK, PK/PD, metabolism and clinical pharmacology). </li><li>Proactively contribute to developing drug candidates across the Research Development and Commercial continuum, providing expert pharmacokinetic / drug metabolism and clinical pharmacology input. </li><li>Be responsible for the PK, PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs/NDAs/BLAs within agreed timelines and which meet regulatory requirements as well as prepare appropriate responses to Health Authority questions (globally). </li><li>Oversee or perform PK and PK/PD analyses using a variety of tools and approaches and integrate, interpret and report data to project teams and other customers. Our organization further offers the opportunity to seamlessly gain exposure to different stages of development, different drug modalities and cross-train in multiple indications.</li></ul>Essential Requirements: <ul><li>Ph.D. or Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related biologic background.</li><li>A minimum of 6 plus years in drug discovery or development function including 2 plus years of experience in a lead role overseeing ADME/DMPK or clinical pharmacology strategy of compound development.</li><li>Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.</li><li>Proficient in the application of PK and PK/PD analysis with working knowledge of software such as WINNONLIN/Phoenix</li><li>Hands-on project experience with compounds of various modalities including low molecular weight and biologics drug discovery and development.</li><li>Proven record as leader with good negotiation, organizational and project management skills.</li><li>Strong coaching and mentoring skills desired. </li></ul>Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $145,600 to $270,400/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.