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Summary The Manager, Technical Compliance, is responsible to support the DI Lead at Gene Therapies North Carolina Site on the Data Integrity Program and support the quality risk management program, including creation, implementation, defining, monitoring and reporting KPIs, creating solutions for KPI improvement and continuous improvement of the program. In addition, the Manager is responsible for the maintenance and monitoring of Quality Engineering and QA IT. The manager will also be responsible for being the Data Integrity Deputy for the GTxNC site. About the Role Location: This position will be located in Durham, NC and will be able to work on Hybrid schedule Key Responsibilities<ul><li>Manages a team that oversees quality engineering and QA IT.</li><li>Manages the team to ensure on time delivery of compliance activities related to QA IT and Quality Engineering.</li><li>Manages the staff responsible for the regulatory CMC related launches and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements</li><li>Supporting the Maintenance and Monitoring of the Quality Risk Management Program</li><li>Assists the DI Lead with proactively drives establishment of Data Integrity culture through implementation and monitoring of the Data Integrity program.</li><li>Serves as the site subject matter expert for all DI-related inquiries/trainings and DI assessment tools.</li><li>Identifies and maintains a network of functional Data Integrity (DI) Subject Matter Experts (SME)/ DI Champions within appropriate GxP functional areas (e.g. Manufacturing, Maintenance, MS&T, engineering, QA Ops, QC, etc.).</li><li>Determines strategy and collaborates with functional DI SMEs/DI Champions to drive behavioral change management activities to strengthen DI culture.</li><li>Drives continuous/sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, etc.</li><li>Manages/Leads DI topics at site in investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties.</li><li>Facilitates the identification of high-risk data processes and systems (via risk assessment, gap assessment, data mapping, etc.).</li><li>Identify and champion opportunities for mid and long-term actions and strategies to reduce DI risk.</li><li>Implementation of DI tools, training materials and guidance (e.g. DI Key cards, Data mapping optimization, audit trail review) at the site according to defined strategy.</li><li>Responsible for supporting QA approval of quality management records for the QA quality systems team.</li></ul>Essential Requirements:<ul><li>BSc in Chemistry, Biology, Pharmacy, business, or related experience.</li><li>Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or Scientific discipline preferred.</li><li>10 years' experience in Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Quality Control, Quality Assurance, Supplier Quality and / or Post Market Quality within the pharmaceutical, diagnostic and / or medical device industries. Experience in advanced therapies (CGT, RLT, etc) is preferred.</li><li>Experience with of industry Data Integrity related experience. Prior experience with aseptic manufacturing is preferred.</li><li>Cross-functional experience in a GxP regulated pharmaceutical industry (e.g Quality Assurance), clinical operations, PV, preclinical operations, manufacturing/engineering operations, Quality Management Departments or equivalent external consultant positions with experience in quality risk management through application of ALCOA+ principles and 21CFR Part 11 requirements. Strong operational background preferred.</li><li>Knowledge of applicable cGMP regulations, for example, FDA Regulations (e.g., 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines,</li><li>EU Pharmaceutical Regulations and Directives, ISO Standards, etc. Strong experience in supporting DI programs, risk analysis, project management, budget, communication and presentation skills.</li><li>Prior experience successfully leading Health Authority Audits / Inspections, including, front room / back room, readiness, strategy and response to findings / observations.</li><li>Experience working in a diverse, fast-paced, local and global SME matrix environment, with ability to drive and manage change.</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 and $ 201,500 annually. 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. #LI-Hybrid 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 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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Manager, Technical Compliance and Data Integrity Lead

Summary #LI-Hybrid Internal job title: Location: This position will be located in Indianapolis, IN or Fort Worth, TX and will not have the ability to be located remotely. This position will require 20% travel as defined by the business We are looking for experience in physical irradiation technologies and related process automation technologies, with an emphasis on isotope production technologies. Our Unit is driving successful execution of a wide range of isotope-related projects. This starts with early strategic and operational discussions on isotope production technologies, assembly of internal teams and execution of desired strategy, up to technical leadership of early process development and the developability assessment of chosen isotope irradiation technologies. You will be reporting to the Head of the Global Isotope Development Unit. You will be leading a Process automation and Physics Development Team consisting of experts from different scientific areas who act as members of radio-isotope development project teams by optimally setting up people, assets, equipment to best serve project needs according to priority, and ensure timely delivery of high-quality products and solutions. About the Role Key responsibilities:<ul><li>Be part of the IDU Leadership team</li><li>Work collaboratively with cross-functional and multidisciplinary teams, spanning multiple NVS global sites develop efficient radio-chemical separation techniques</li><li>Co-lead projects with project lead; formulate and execute on project strategy, manage interfaces with project leads, including timelines, priority, board presentations.</li><li>Build and lead internal Radiochemical team of experimental scientists and project leads. Seek technical and operational input from key stakeholders to build the project execution plan.</li><li>Lead internal project meetings. Collect and interprets data to advance project, adapts strategy, and addresses the right scientific questions. Ensure team discussions and decisions are summarized in minutes. Ensure that key milestones and go / no go criteria are data driven and clearly defined. Own quality of project information and make sure project information is accurate and included in the system(s) in a timely matter.</li><li>Guide projects with respect to isotope approaches and technologies and leads corresponding efforts. Lead developability assessment, manufacturing line development and early process development. Track and oversee projects by maintaining an overview of the project goals, activities and commitments, and timelines of project teams, in line with strategic priorities. Manage and optimize project plans and resource assignments with the aim to manage/mitigate risks.</li><li>Align with RLT LT project strategy and resourcing. Regular project/portfolio updates to IDU LT.</li><li>Manage and communicate project status, issues, and options for resolution to ensure optimal and timely information flow to all stakeholders (NTO and TRD). </li><li>Foster effective, proactive and open communication within and across project teams, build trust among team members to achieve transparency and clarity of program goals, progress and issues. Mentor less experienced team members.</li><li>Contribute to vendor/CRO evaluations, coordination of outsourcing requests, budget monitoring and communication, evaluation of external collaborations and due diligence.</li><li>Ensure best practices, knowledge exchange and continuous mentoring and training of our team members.</li></ul>Essential Requirements:<ul><li>A minimum of a Bachelors degree is required. Master's or PhD is preferred</li><li>At least 5 years of relevant experience in radiopharmaceuticals or related fields, with a strong focus on process automation and physics; academic experience will also be considered</li><li>Strong background in Radiochemistry and radio-isotope production technologies including irradiation technologies and accelerators</li><li>Previous track record of success in leadership position, working with international and multidisciplinary development teams</li><li>Ambitious, yet highly collaborative and fully committed to team's and project success.</li><li>Result- and quality oriented. Able to deal with conflicting interests and willing to make compromises to ensure project progress.</li><li>Excellent project management skills, organizational and team management skills, interpersonal communication, strong verbal and written communication.</li><li>Creativity with demonstrated critical thinking and problem-solving skills, ability to pay attention to detail but also see a bigger picture.</li><li>Comfortable with ambiguity and change, eager and fast learner willing to adopt new tools and processes.</li><li>Ability to operate in a fast-paced dynamic environment and effectively process multiple avenues of communication and requests in parallel</li></ul>The salary for this position is expected to range between $145,600.00 - $270,400.00 USD Annual 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 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.

Associate Director Physics Team Leader and Process Automation

Summary Manage Quality aspects of clinical programs and projects within area of responsibility. Ensure and support overall GxP conformity and Compliance with the Novartis Quality Management Systems. Identify and execute on OpEx opportunities. Build/manage stakeholder relationships and expectations About the Role Location: Durham, NC #LI-Onsite Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Major accountabilities: <ul><li> Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting -Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner -Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual -Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. </li><li> Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality. </li><li> Contributes to an improvement of current processes and/or to an implementation of modified processes. </li><li> Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate. </li><li> Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments -Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation Supports Compliance review of projects and inspection readiness and management -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) </li></ul> Key performance indicators: <ul><li> In accordance with departmental objectives such as support of projects with agreed quality and delivery date -passing of internal and external inspections. </li><li> Maintain sound working relationships with partners and customers -Demonstrated/recognized leader of specific GxP; early external/industry engagement -Basic financial knowledge (e.g., cost management, budget forecast, etc.) -Role Model of Novartis culture, values & behaviors for his/her department </li></ul> Minimum Requirements: Work Experience: <ul><li> Functional Breadth. </li><li> Collaborating across boundaries. </li><li> Operations Management and Execution. </li><li> Project Management. </li></ul> Skills: <ul><li> Agility. </li><li> Audit Management. </li><li> Business Partnering. </li><li> Change Control. </li><li> Continuous Learning. </li><li> Health Authorities. </li><li> Influencing Skills. </li><li> Knowledge Of Capa. </li><li> Qa (Quality Assurance). </li><li> Quality Management. </li><li> Quality Management Systems (Qms). </li><li> Risk Management. </li><li> Root Cause Analysis (Rca). </li><li> Self Awareness. </li><li> Sop (Standard Operating Procedure). </li><li> Technological Expertise. </li></ul> Languages : <ul><li> English. </li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $77,000 and $143,000 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 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, Quality Control Microbiology

Summary The Senior Automation Engineer reports to the AD Process Automation and is responsible for providing automation design team leadership and serving as a technical subject matter expert for a Novartis Aseptic Drug Product facility. About the Role Location: This position will be located in Durham, NC and will be an On-Site role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities:<ul><li>Ensure automation aspects of new equipment are appropriately designed, meet Novartis standards and are appropriately commissioned and qualified.</li><li>Provide oversight for automation aspects of projects including integration of 3rd party equipment to other standard plant systems, e.g., DCS, BMS, Historian, Infrastructure.</li><li>Provide design, configuration, installation, and maintenance of automation software and associated hardware for existing equipment and processes.</li><li>Prepare scopes of work for large projects, lead small teams and manage automation contractors as required to complete required work within project timelines.</li><li>Lead discussions with internal business partners on priorities, timelines and transparent sharing of information.</li><li>Develop, review and approve lifecycle documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).</li><li>Develop and maintain procedures to meet GMP requirements, CFR's and internal company policies.</li><li>Participate and/or lead new product implementation processes to ensure smooth transition from process development into GMP manufacturing.</li><li>Drive operational excellence and continuous improvement.</li><li>Partner with Quality to ensure a quality and compliant manufacturing environment including participation in regulatory audits as an automation SME.</li><li>Solve technical related issues impacting production.</li><li>Support 24x7 site-based operations including rotating on-call responsibilities.</li><li>Support investigations of non-conformances related to automation systems.</li><li>Other related duties as assigned.</li></ul>Essential Requirements:<ul><li>B.S. degree in Engineering, Computer Science, or related technical field.</li><li>8 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (12 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.</li><li>Excellent oral and written communication skills, including demonstrated technical writing skills.</li><li>Experience programming, troubleshooting, and maintaining various site automation systems including DCS, BMS, PLC, SCADA, historian, infrastructure, including use of various industrial protocols.</li><li>Experience in development and execution of system level qualification testing including providing guidance on qualification plans in conjunction with C&Q department.</li><li>Proven experience applying S88 in an automated environment and development of control system standards aligning with S88 methodology.</li><li>Experience in field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and experience with instrumentation.</li><li>Experience writing and executing complex change controls.</li><li>In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.</li><li>Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.</li><li>Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.</li><li>Provide technical support on all manufacturing issues when driving towards issue resolution.</li><li>Up to 10% travel may be required.</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $103,600 and $ 192,400 annually. 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. #LI-Onsite 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 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 Engineer, Automation

Summary The Senior Manager, CGT ITOT/Automation, reports to the AD, Process Automation and leads a team of site-based automation engineers to install, maintain and support automation systems primarily associated with Aseptic Drug Product equipment and facilities. About the Role Location: This position will be located in Durham, NC and will be an On-Site role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities:<ul><li>Leads automation processes for the design, installation, maintenance and support of process equipment and automation systems.</li><li>Continuously improves and seeks innovation related to site automation systems.</li><li>Executes automation strategy and proper system management per global Novartis standards.</li><li>Owns computerized systems for process related equipment.</li><li>Manages engineers supporting 24/7 operations providing clear, consistent leadership, management and mentoring.</li><li>Develops, monitors and improves KPI's for system reliability.</li><li>Change management and CAPA ownership to drive continuous improvement for automation systems.</li><li>Leads SME's for deviation investigations involving automation systems.</li><li>Leads SME's for automation systems in regulatory audits.</li><li>Ensures training curriculum is optimized and ensures cross training of individuals across the team.</li><li>Supports creation of standard lifecycle documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS), etc.</li><li>Works closely with operations and manufacturing sciences to evaluate new product introductions and impact to automation systems.</li><li>Supports the development of site facility and equipment master plans, network business processes associated with automation systems, and GTx Engineering initiatives or programs.</li><li>Other related job duties as assigned.</li></ul>Essential Requirements:<ul><li>Bachelor of Science degree in Engineering or other relevant degree with 9 years of experience across multiple ITOT/Automation platforms, e.g., DCS, PLC, SCADA, MES, Historian, as well as experience with process equipment in the drug substance and drug product areas.</li><li>Industry expertise in the design, reliable operation, modification, maintenance, and retirement of computerized systems.</li><li>Demonstrated ability to work and collaborate on cross functional teams (QE, QA, validation, operations) in a fast paced, dynamic team setting.</li><li>Strong interpersonal and excellent verbal and written communication skills are essential.</li><li>Knowledgeable of health, safety and environmental regulations, and FDA (and similar) cGMPs.</li><li>Planning, problem analysis, and decision-making skills.</li><li>Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS).</li><li>Self-motivated with a strong sense of ownership in areas of responsibility.</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 and $ 201,500 annually. 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. #LI-Onsite 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 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 Manager, CGT ITOT/Automation

Summary The Buyer Planner II plays a pivotal role in keeping operations running smoothly. This position oversees the entire journey of inventory materials - from the moment an order is placed to time of delivery, ensuring precision and timeliness every step of the way. Beyond tracking, this role drives innovation by sourcing new materials that power our manufacturing and lab activities, including identifying and partnering with the right suppliers to keep us ahead of the curve. About the Role Location: Durham, NC #LI-Onsite This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you Key Responsibilities: &bull; Perform periodic review of supplier performance and work with his/her manager to alleviate any supplier issues. Periodic review may require setting reoccurring meetings with key suppliers. &bull; Support the Process Science Team by attending weekly production meetings, forecasting material needs and coordinating with the warehouse to ensure materials are available for scheduled production. &bull; Track all raw materials from time of purchase to time of receipt. &bull; Maintain data within the ERP system. &bull; Attend/host regular meetings with suppliers to review open orders/supplier performance. &bull; Accountable for maintaining inventory at planned levels. &bull; Works with manufacturing and lab teams to identify and source new raw materials. &bull; Maintain and update the Item Master as requested. &bull; Create and report key performance metrics related to purchasing and inventory management. &bull; Identifies and sets-up new suppliers through the Supplier Quality Management process. &bull; Work closely with Strategic Procurement to negotiate supply agreements, blanket orders and long-term purchase agreements. &bull; Forecast/Plan material needs to support manufacturing. &bull; Assist Warehouse team with any incoming receipt issues. &bull; Other related duties as assigned. Essential Requirements: &bull; B.S. degree in supply chain, engineering, science, business or related degree or an equivalent combination of education and related experience. &bull; 2 years of supply chain or buyer/planner experience preferred. &bull; Must be able to operate with limited supervision and exercise proper judgment. &bull; Strong communication and organizational skills, detail oriented. &bull; Proficient in MS Office suite of products. &bull; Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. &bull; Approximately 5% travel. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $63,600 and $118,200 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. 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 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.

Buyer Planner II

Summary This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 20% travel as defined by the business (domestic and/ or international). The Director, Business Excellence Lead will be responsible for providing ongoing strategic, operational, and business planning recommendations/ plans to the Integrated Product Strategy Team (IPST) that will increase impact of our product(s). This unique role will be integrating product and portfolio insights and analytics across functions; and distill the most important insights and actions that drive impact. Lead preparations for critical performance reviews, investor relations and business reviews with various leadership teams; as well as lead cross functional team impact reviews to assess progress against KPIs that are integrated across all functions. Lead strategic core initiatives across the product/ portfolio that will have long lasting impact for patients in need of, or treated with, our products and the ideal candidate is passionate about both strategy, insights and analytics and operational specificity required to translate strategy to impact. This individual will play an integral role in driving excellence in execution across the business. About the Role Key Responsibilities: <ul><li> Run the Integrated Product Strategy, including the setting of priorities, agendas, action items, and follow-ups </li></ul><ul><li> Lead strategic, operational, and business planning recommendations/ plans to GM and leadership teams </li></ul><ul><li> Lead integration of product insights from multiple functions to prioritize the most impactful actions </li></ul><ul><li> Lead preparations for impact reviews with various stakeholders across local and global landscape </li></ul><ul><li> Lead creation of investor relations package and narrative for assigned product(s) </li></ul><ul><li> Lead large cross-functional strategic projects that aim to improve operational efficiency and/or result in significant customer impact </li></ul><ul><li> Partner with finance and insights and analytics to identify criteria for, and measure resource allocation decisions </li></ul><ul><li> Ensures alignment to, compliance with, and ownership of all NPC policies, including the Code of Conduct and all applicable laws and regulations. </li></ul>Essential Requirements:<ul><li> 8+ years in pharmaceutical, biotech, healthcare, or healthcare consulting industry inclusive of at least 2 different types of cross-functional roles/experience </li></ul><ul><li> 2+ years in project management and translation of strategy into execution </li></ul><ul><li> 2+ years leading complex projects requiring global and local alignment </li><li> Education: Bachelor's Degree is required in relevant area, MBA or relevant graduate degree preferred </li></ul>Desirable Requirements:<ul><li> Therapeutic Area experience </li></ul><ul><li> 2+ years within a significant consultancy group ( e.g. McKinsey, BCG, Bain) </li><li> Minimum 5+ year commercial experience preferably with multi -functional experience in a pharmaceutical, biotech, healthcare, or consulting environment </li><li> Demonstrated strategic acumen </li><li> Strong analytical skills and an ability to generate insights and develop relevant action plans </li><li> Strong ability to simplify complex concepts & strategies and tell a story " orally and in writing </li><li> Curious, with excellent listening skills; able to challenge current thinking </li><li> Track record of exceptional performance and execution that drives results </li><li> Ability to lead, manage and motivate teams, with or without authority </li><li> Experience working collaboratively across the matrix </li><li> Strong influencing skills, and the ability to exercise tact and diplomacy in stressful situations </li><li> Ability to manage multiple priorities and a heavy workload </li></ul> The pay range for this position at commencement of employment is expected to be between: $185,500.00 and $344,500.00/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 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, Business Excellence Lead, ASCVD

Summary #LI-Onsite Location: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible. Join us in shaping the future of pharmaceutical manufacturing! As an Senior Engineer, Utility, you'll play a critical role in ensuring the reliability and efficiency of essential utility systems that power life-changing therapies. This is your opportunity to lead impactful projects, drive innovation, and collaborate with cross-functional teams to maintain world-class standards. Your expertise will help safeguard compliance, optimize performance, and support continuous improvement - making a real difference in patient outcomes and operational excellence. About the Role Key Responsibilities:<ul><li>System ownership responsibilities for site-based utility, electrical, and HVAC systems; including but not limited to water-for-injection, water pre-treatment, chillers, boilers, compressed gases, plant steam/condensate, wastewater, biowaste inactivation, air handling units, cold rooms, switchgear, emergency generators, cooling towers, fire protection, and control systems.</li><li>Oversee installation, maintenance, troubleshooting, and repair of critical facility and utility assets to ensure reliability and minimize downtime.</li><li>Manage equipment changes and upgrades to maintain validated states, ensuring compliance with qualification and regulatory requirements.</li><li>Create, review, and approve essential documentation including SOPs, engineering drawings, maintenance plans, and equipment specifications to support robust operations.</li><li>Investigate non-conformance events and alarm issues, applying root cause analysis and developing effective engineering solutions to prevent recurrence.</li><li>Drive operational excellence initiatives, implementing strategies to optimize system reliability, reduce failure modes, and improve energy efficiency.</li><li>Provide SME-level leadership on projects, guiding all phases from concept through closeout, ensuring timely delivery and adherence to quality standards.</li><li>Collaborate with cross-functional teams including operations, quality, and manufacturing sciences to achieve site objectives and support new product introductions.</li><li>Mentor and coach junior engineers, fostering technical growth and promoting best practices across the engineering team.</li></ul>Essential Requirements<ul><li>B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with a minimum of 8 years' work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry</li></ul>OR<ul><li>Associate's degree/Diploma/Certification in Engineering Technology or Related Skilled Technical Field, with a minimum of 10 years work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry</li></ul>OR<ul><li>Equivalent work experience (12+ years) experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry</li></ul>AND<ul><li>Strong technical writing skills and ability to create clear, compliant documentation</li><li>Proven expertise in troubleshooting complex equipment and applying root cause analysis techniques</li><li>Hands-on experience with automated building management systems and industrial PLCs</li><li>Demonstrated ability to lead projects from initiation through completion, ensuring compliance and timely delivery</li><li>Excellent communication and collaboration skills, with a track record of working effectively in cross-functional teams</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $103,600 and $192,400 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. 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 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 Engineer, Utility

Summary Location: East Hanover, NJ, (Hybrid) #LI-Hybrid This is an on-site role, at minimum 3 days/week. Job Purpose The US People and Organization (P&O) team is seeking a new People Partner to support teams in the Development Business Unit of Novartis. 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: &bull; First point of escalation for all leaders and managers on their day-to-day P&O topics, providing expert advice, guidance and support. Accountable for credible P&O People Partnering to leaders, managers and associates, offering advice and guidance on the moments that matter. Coaches and guides people managers on role evaluations in line with local governance. May consult and advise on Team Effectiveness including Psychological Safety. &bull; Implements P&O initiatives, supporting the overall P&O strategy. Ensure People Partnering processes are accomplished with high quality and efficiency. Champions culture and supports implementation of corporate initiatives. &bull; 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. &bull; Embraces customer feedback to understand the customer journey with moments that matter and makes recommendations for continuous improvement. Implement enhancements and modification as necessary to meet both the business and customer needs. &bull; Ensure compliance with local equity / Equal Employment Opportunity (EEO) regulations. &bull; Manage the delivery of in-country transformations, consult with legal, provides advice and guidance for managers through the local US process, oversee associate notice / handover meetings and overall restructuring life cycle. &bull; Manage the execution of local implementation of large-scale organizational and day-to-day organizational structure changes, in line with country regulations / policies. &bull; Ensures local Employee Relations regulations are in line with local regulations and Novartis integrity standards from a cross divisional / country lens. Manages Employee relations within client group, coaching and mentoring associates and managers. &bull; Manage internal movement offers and mobility. &bull; Promotes the contribution of ideas and solutions to the P&O network (Country Business Partners, Global Business Partners and Country P&O Boards). Seeks to establish strong relationships with cross-divisional P&O community members to understand needs and challenges and drive continuous improvement. &bull; Support and coach leaders, manager and associates on all P&O topics including promoting self-sufficiency in people processes. Provides coaching and counselling to Country P&O Business Partners on local policies and processes. What you will bring to the role: &bull; BA Degree in a relevant HR or related discipline. &bull; At minimum 5+ years' work experience in P&O - with breadth of experience across P&O disciplines. At minimum 3+ years supporting a complex and matrix organization within the US. A good understanding of global organizations will be an advantage. HR experience supporting a pharmaceutical or biotech development team is preferred. &bull; Strong Interpersonal skills; Proactive, responsive and ability to work independently with all levels of the organization. Ability to handle multiple conflicting tasks and work in an agile way to support a fast-paced environment is a must. Stakeholder Management and ability to collaborate across boundaries. &bull; 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. &bull; Fluency in English both oral and written communication skills. &bull; Experience working in a variety of organizations country wide. The salary for this position is expected to range between $ 98,700 to $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 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.

People Partner

Summary Lead the reliability backbone of our Morris Plains, New Jersey site. As Senior Manager, Engineering - Asset Lifecycle Management, you will guide a team of site-based engineers to ensure every process and laboratory asset is designed, maintained, improved, and retired with intention. You will set maintenance strategy, champion data-driven reliability, and own master data and Key Performance Indicators to keep equipment available, compliant, and audit-ready. Partner across Operations and Manufacturing Sciences to support new product introductions, define User Requirements, Functional Specifications, and Detailed Design Specifications, and drive facility changes aligned to five- and ten-year plans. By strengthening Root Cause Analysis and Corrective and Preventive Action disciplines and investing in training and cross-skilling, you will directly enhance patient safety, regulatory confidence, and uninterrupted production. #LI-Onsite Location: Morris Plains, NJ About the Role Key Responsibilities: &bull; Define and continuously improve site maintenance strategy for all equipment. &bull; Execute asset lifecycle management to meet global Novartis standards. &bull; Lead the site reliability program using data-driven approaches. &bull; Mentor and manage engineers supporting 24/7 operations. &bull; Own and optimize master data for process, utility, Quality Control, and Technical Research and Development equipment. &bull; Develop, monitor, and enhance Key Performance Indicators for system reliability. &bull; Drive change management and Corrective and Preventive Actions to ensure equipment reliability. 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. Essential Requirements: &bull; Bachelor's degree in Engineering. &bull; Minimum 5 years of engineering experience in a Good Manufacturing Practice-regulated environment. &bull; Proven experience with regulatory audits and inspections. &bull; Demonstrated use of Root Cause Analysis tools (5 Whys, Fishbone, Failure Modes and Effects Analysis). &bull; Strong background in leading or supporting investigations. &bull; Excellent communication and leadership skills. Desirable Requirements: &bull; Professional experience in Reliability Engineering. &bull; Experience in the pharmaceutical industry. 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 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 Manager,  Engineering - Asset Lifecycle management

Summary The Senior Manager, Regulatory Ad Promo will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy. The ideal location for this role is the East Hanover site 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 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 20% travel. About the Role Key Responsibilities:<ul><li>Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (MAP") teams. May include a launch product or indication with oversight.</li><li>Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H with oversight. Establishes strong and positive working relationship with OPDP reviewers.</li><li>Manages OPDP queries on assigned products.</li><li>Applies regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to US promotional issues.</li><li>Ensures regulatory compliance while effectively managing business risks.</li><li>Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.</li><li>Prepares complaint letters to OPDP with oversight.</li><li>Serves as regulatory reviewer for non-promotional medical materials as required by process</li><li>Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.</li><li>Collaborates with Regulatory Development colleagues to provide input to study designs or US label with regard to feasibility of promoting potential data/claims with oversight.</li><li>Participates/assists in US labeling negotiations and FDA meetings as necessary.</li><li>Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.</li></ul>Essential Requirements: Education: BS Degree or equivalent. Advanced degree desirable (MS, PhD, PharmD, or JD)<ul><li>Knowledge of drug development process</li><li>Ability to analyze and interpret efficacy and safety data desired.</li><li>Understanding of business goals of the involved business franchise, marketing concepts and tools.</li><li>Must be able to work in a multi-disciplinary environment.</li><li>Must process strong interpersonal and communication skills.</li><li>Must have analytical and problem-solving skills associated with problem review and inquiries.</li><li>Must be able to provide creative solutions to problems.</li></ul>Novartis Compensation Summary: 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 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 Manager, Regulatory Ad/Promo

Summary The Isotope Shift Supervisor is responsible for the daily operations of the production team, specifically the direction and management of manufacturing operations to deliver high quality isotope products in a safe, compliant, efficient and cost-effective manner. In addition, successful execution of this role ensures all manufacturing operations within scope occur in compliance with both HSE and GMP regulations. About the Role Major accountabilities: <ul><li>Ensures the Shop Floor achieves targets for Quality, Safety, and Productivity (Production throughput times and batch record review).</li><li>Lead and facilitate shop floor meetings, making schedule and personnel adjustments as necessary to properly staff the modules.</li><li>Maintain an "audit ready" shop floor. Assist with internal pre-audit walkthroughs, CGMP housekeeping and general organization of manufacturing spaces.</li><li>Maintain a daily physical presence with direct reports on and off the shop floor to supervise, coach, and support.</li><li>Ensure Associates are demonstrating the proper aseptic techniques & behaviors.</li><li>Possess basic technical knowledge and background on multi product processes.</li><li>Proficient in the use of production related IT systems such as SAP, LIMS, and MES.</li><li>Responsible for training of all direct reports, including the on-time completion of required training curriculum comprised of global and local SOPs.</li><li>Adhere to all SOPs, cGMPS, and safety rules and regulations; ensure Associates are executing tasks per approved policies and applicable procedures.</li><li>Coordinate, monitor, and improve, production process with a Quality and Continuous improvement mindset.</li><li>Work with team to resolve and implement Corrective Actions and Preventative Actions (CAPAs).</li><li>Support Associates throughout the year during one-on-one discussions and periodic check-ins to achieve annual objectives and development opportunities.</li><li>Manage any disciplinary actions (including PiPs) with direct reports</li><li>Participate in hiring strategy</li><li>Compile area metrics, reports, and performance levels as required; draft and deliver reports to higher level management.</li></ul>Essential Requirements: <ul><li>3-5 year's cGMP manufacturing, cell culture/ cell therapy preferred</li><li>Proven process understanding (Pharma, cGMP, Regulatory Aspects)</li><li>Project management, Operational Excellence, Product/Process Development or Regulatory experience a plus.</li><li>Contribute to site Manufacturing financial/business goals</li><li>Maximize Quality and Process improvements</li><li>Minimize rejected patient lots, media, and write-offs</li><li> Bachelors degree required or 3-5 years of relevant experience in lieu of degree</li><li>1-2 years experience in a Lead or Supervisory role required, with focus on ensuring training and process compliance during daily operations</li></ul>Shift: Weekend days, 12 hours 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 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.

Shift Supervisor, Weekend Days

Summary The Business Operations Lead role in External Innovation (EI) is a strategic and essential position to deliver Biomedical Research's (BR) external innovation and academic collaboration strategy efficiently and compliantly The BR Business Operations Lead supports the goals of the BR EI team by leading essential operational responsibilities, supporting the Global Head of Academic Partnership (AP) and External Innovation (EI) and staff, driving and ensuring optimal alignment of resources and engaging with the wider BR community. #LI-Hybrid Internal Title: Business Operations Lead Location: Cambridge This role is based in Cambridge, MA. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. About the Role Key Responsibilities: Strategic and operational impact<ul><li>The Business Operations Lead role in AP&EI is crucial for implementing our external innovation and academic collaboration strategy efficiently and compliantly.</li><li>This strategic role interfaces with key stakeholders, including Disease Areas (DAs)/Functional Areas (FAs), Ethics Risks and Compliance (ERC), Legal, Finance, academia, and Heads of Operations, aligning projects, resources, and priorities.</li><li> As a member of the EI Leadership Team (LT), this position facilitates complex coordination and process improvement, freeing scientific and senior leaders to focus on strategic and scientific priorities.</li><li>Responsible for leading and driving key cross-functional projects within AP&EI that will support BR's and DAs/FAs strategic interests with academic partners (such as the Early Career Investigator Program, Lead for EI workstreams, Lean In sessions, and EI Updates, Offsite ownership: lead working group for setting agenda, logistics, host for the offsite)</li></ul>Governance of the External Scientific Monetary Support Program (ESMSP)<ul><li>This role is critical in the governance of BR's External Scientific Monetary Support Program (ESMSP) and is fully accountable for the External Scientific Monetary Sponsorship Fund and plays a critical role that requires significant leadership and expertise to identify potential risks when working with third parties.</li><li>Leads the Global Sponsorship Governance Committee meetings which includes the Swiss Fund requests ensuring similar review and triage is conducted and Corporate Funding requests.</li><li>Management of ESMSP requires dedicated ownership of the GEMS database, ensuring compliance, audit readiness, and reducing reputational risk.</li><li>Responsible for reviewing and triaging external sponsorship requests (>150/year) for ESMS, collaborating with DAs/FAs, ERC, and Finance to develop funding strategies and ensure legal compliance (validity of the requestor and engagement with ERC country representative for country code compliance) to reduce risk.</li></ul>Visibility, branding, and partner experience<ul><li>The role centralizes key activities that shape BR's external image reviewing with COMMS third party Communication request, preparing partnering materials, brochures, presentations, and web presence. Coordinates Novartis (NVS) events at partnering conferences such as BIO, AUTM, HBCU Engage and government delegation visits at BR. Serves on panels at conferences (i.e. HBCU Engage) based on topic.</li></ul>Leadership support and financial stewardship<ul><li>The Global Head of AP&EI requires reliable operational and executive support for complex internal and external engagements, leadership meetings, travel, and onboarding.</li><li>In partnership with Finance, plans, tracks, and optimizes the global EI budget, ensuring spending is aligned with strategy and transparently managed.</li></ul>Essential Requirements:<ul><li>B.S. or B.A. in a science or business-related field</li><li>4+ years' experience providing administrative support and managing projects for executives in a global pharmaceutical setting</li><li>Must be able to maintain confidentiality on sensitive matters as needed</li><li>Knowledge and use of MS Word, Outlook, Excel, PowerPoint and Proficiency in the design and use of databases such as SharePoint</li></ul><ul><li>Previous experience in preparing presentations, partnering brochures, web design</li></ul><ul><li>Able to multitask and prioritize multiple responsibilities and projects, and flexibility to adapt to changing priorities?</li><li>Strong organizational abilities and time management skills with keen attention to detail</li><li>Demonstrated ability to work cross-functionally and align interests of multiple parties</li><li>Strong interpersonal skills, high level of self-motivation and drive</li><li>Excellent written and oral communication skills</li></ul>Desirable Requirements:<ul><li>Masters degree in a science or business-related field</li><li>Experience in R&D setting preferred</li></ul>The salary for this position is expected to range between $70,000 and $130,000 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. 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 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.

Business Operations Lead- External Innovation

Summary The Isotope Shift Supervisor is responsible for the daily operations of the production team, specifically the direction and management of manufacturing operations to deliver high quality isotope products in a safe, compliant, efficient and cost-effective manner. In addition, successful execution of this role ensures all manufacturing operations within scope occur in compliance with both HSE and GMP regulations. About the Role Major accountabilities: <ul><li>Ensures the Shop Floor achieves targets for Quality, Safety, and Productivity (Production throughput times and batch record review).</li><li>Lead and facilitate shop floor meetings, making schedule and personnel adjustments as necessary to properly staff the modules.</li><li>Maintain an "audit ready" shop floor. Assist with internal pre-audit walkthroughs, CGMP housekeeping and general organization of manufacturing spaces.</li><li>Maintain a daily physical presence with direct reports on and off the shop floor to supervise, coach, and support.</li><li>Ensure Associates are demonstrating the proper aseptic techniques & behaviors.</li><li>Possess basic technical knowledge and background on multi product processes.</li><li>Proficient in the use of production related IT systems such as SAP, LIMS, and MES.</li><li>Responsible for training of all direct reports, including the on-time completion of required training curriculum comprised of global and local SOPs.</li><li>Adhere to all SOPs, cGMPS, and safety rules and regulations; ensure Associates are executing tasks per approved policies and applicable procedures.</li><li>Coordinate, monitor, and improve, production process with a Quality and Continuous improvement mindset.</li><li>Work with team to resolve and implement Corrective Actions and Preventative Actions (CAPAs).</li><li>Support Associates throughout the year during one-on-one discussions and periodic check-ins to achieve annual objectives and development opportunities.</li><li>Manage any disciplinary actions (including PiPs) with direct reports</li><li>Participate in hiring strategy</li><li>Compile area metrics, reports, and performance levels as required; draft and deliver reports to higher level management.</li></ul>Essential Requirements: <ul><li>3-5 year's cGMP manufacturing, cell culture/ cell therapy preferred</li><li>Proven process understanding (Pharma, cGMP, Regulatory Aspects)</li><li>Project management, Operational Excellence, Product/Process Development or Regulatory experience a plus.</li><li>Contribute to site Manufacturing financial/business goals</li><li>Maximize Quality and Process improvements</li><li>Minimize rejected patient lots, media, and write-offs</li><li> Bachelors degree required or 3-5 years of relevant experience in lieu of degree</li><li>1-2 years experience in a Lead or Supervisory role required, with focus on ensuring training and process compliance during daily operations</li></ul>Shift: Weekend nights, 12 hours 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 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.

Shift Supervisor, Weekend Nights

Summary The location for this role is East Hanover, NJ. There are 2 Associate Director, Companion Diagnostics Metrics positions associated with this job posting. The roles are as follows: 1- Associate Director, Companion Diagnostics Metrics 2- Associate Director, Companion Diagnostics Metrics 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 ED, Personalized and Precision Medicine , this role is crucial in advancing the frontiers of personalized healthcare. The role of the Associate D irector Companion Diagnostics Metrics is at the forefront of utilizing EHR, clinical and diagnostic data from a specific type of diagnostic to tra ck metrics on companion diagnostics availability, offering, and usages. Key Responsibilities :<ul><li> Collaborate with cross-functional team to analyze healthcare data, including clinical trial datasets, transactional claims, and electronic health records. Apply established statistical and analytical techniques to support patient identification, diagnostics utilization , and RWE analytics. </li></ul><ul><li> Collaborate with providers to identify eligible patients in their existing patient pools. Support the analysis of provider EHR to facilitate patient identification. </li></ul><ul><li> Utilize data generated by digital health technologies (DHTs) to capture patient-generated data, electronic patient-reported outcomes (ePROs), and electronic clinical outcome assessments ( eCOAs ). Support efforts in patient identification, diagnostic utilization , and RWE analytics. </li></ul><ul><li> Monitor and report on metrics related to companion diagnostic availability, offering, and usage. </li></ul><ul><li> Support the analysis of real-world evidence and clinical & diagnostic data to identify patterns and indicators associated with patient response to treatment regimens, focusing on genetic and biomarker indicators. </li></ul><ul><li> Contribute to the drafting and reviewing of technical and study reports, manuscripts for publishing in high-impact peer-reviewed journals, and abstracts and presentations for international conferences. </li></ul><ul><li> Communicate complex concepts and interpretations of analysis and findings to various audiences, including internal leadership and stakeholders, health economists, clinicians, and health systems. </li></ul><ul><li> Share relevant insights on underdiagnosed or undertreated patients with the Patient Finding team to support their initiatives . </li></ul> Novartis seeks an individual with extensive experience in the pharmaceutical or healthcare industry, with a strong understanding of personalized and precision medicine approaches . This individual should have a proven track record in applying epidemiological principles to assess target patient populations and inform treatment strategies . A strong analytical background is essential, with the ability to analyze complex datasets and derive actionable insights. Education:<ul><li> Bachelor's degree in related field is required ; Master of Science and/or MBA preferred </li><li></li></ul>Essential Requirements:<ul><li> Minimum 6 years of experience in the pharmaceutical or healthcare industry, with a deep understanding of personalized and precision medicine </li><li> 5+ years of domain expertise in these areas are highly desired: Personalized and precision healthcare secondary data analytics, data science, primary market research, field analytics and insights, market access and patient service analytics, or other related strategic analytics and management consulting </li></ul><ul><li> 5+ years of people management experience. Proven track record of enabling data-driven decision-making at a senior leadership level, including addressing complex business challenges and shaping organizational strategy particularly in therapeutic areas </li></ul><ul><li> Proficiency in analyzing healthcare data, including clinical trial datasets and electronic health records, using advanced statistical techniques (e.g., data modelling, time to event analysis) </li></ul><ul><li> Familiarity with digital health tools / technologies and their application in capturing patient-generated data and outcomes </li></ul><ul><li> Experience in working with clinical and diagnostic data to identify genetic and biomarker indicators that influence treatment efficacy </li></ul><ul><li> Ability to draft and review technical reports, manuscripts, and presentations for high-impact scientific publications and conferences </li></ul> Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $132,300.00 and $245,700.00 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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 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.

Associate Director, Companion Diagnostics Metrics (1 of 2)

Summary This position will be located at the East Hanover, NJ location and will not have the ability to be located remotely. This is 1 of 2 roles. About the Role The Insights and Decision Science (IDS) team is dedicated to enabling improved decision making at Novartis by leveraging superior data to identify actionable insights that drive enhanced performance. We collaborate closely with the US business, bringing insights and challenging ideas to empower smarter, data-driven decision-making. Reporting into the ED, AI and Innovation Data Science, this role is crucial in leading the development and deployment of advanced AI solutions that enhance operational efficiency and drive strategic growth across the organization. This position plays a vital role in integrating AI-driven solutions across various platforms, fostering collaboration between the US commercial team and the India-based data science team. By championing the exploration of cutting-edge AI technologies, the Director ensures that our strategies are informed by the latest advancements in generative AI and large language models (LLMs). This role will collaborate with other members of the IDS AI and Innovation team members to create, pilot, and scale AI tools to support broader goals of the IDS strategy to transform business processes and outcomes. Key Responsibilities: <ul><li> Lead the development and deployment of scalable AI solutions, focusing on advanced AI applications across various business units. </li></ul><ul><li> Be prepared to engage in hands-on work when necessary to support the team and further our data science initiatives. </li></ul><ul><li> Collaborate with cross-functional teams to integrate AI-driven solutions across various platforms and services. </li></ul><ul><li> Drive innovation by staying current with advancements in AI, particularly in generative models and LLM technologies. </li></ul><ul><li> Champion the exploration and integration of cutting-edge AI technologies, particularly in the field generative AI. </li></ul><ul><li> Act as a key liaison between the US commercial team and the India-based data science team. </li></ul><ul><li> Stay abreast of state-of-the-art foundation models and other innovative trends in data science and leverage these insights to inform our strategies. </li></ul><ul><li> Bring a can-do" attitude and teamwork and inspire others on culture change. </li></ul><ul><li> Acts as an AI role model , championing a culture that embraces cutting-edge AI technologies and encourages experimentation and adoption of best practices </li></ul>Experience: Novartis is seeking an i ndividual with proven experience working with machine learning models. They should have a strong ability to support cross-team development of A I programs . A firm commitment to driving continuous improvement in AI solutions, informed by current innovations , is vital to this role. Essential Requirements: <ul><li> Advanced degree in Computer Science, Engineering, Statistics, or related field </li></ul><ul><li> Minimum of 10 years of experience in data science, with 6-8 years of experience in the pharmaceutical industry </li></ul><ul><li> Build and deploy scalable machine learning models using cloud-based services such as AWS and Azure </li></ul><ul><li> Strong understanding of deep learning algorithms, foundational/ LLM models, statistics, and recommendation system </li></ul><ul><li> Deep knowledge of Large Language Models (LLMs) such as GPT, BERT, Cohere, and their applications in real-world scenarios. </li></ul><ul><li> Ability to operate in a hands-on capacity when necessary. </li></ul><ul><li> Proficient in programming languages such as Python, Spark, TensorFlow, and PyTorch </li></ul><ul><li> E xperience with digital channel selection for next best action" </li></ul><ul><li> Excellent problem-solving skills and ability to identify creative solutions to complex problems </li></ul><ul><li> Strong ability to effectively communicate and work across different time zones </li></ul> The pay range for this position at commencement of employment is expected to be between: $194,600.00 and $312,400.00 a 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 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, Data Science 1 of 2

Summary #LI-Hybrid One of the most important functions in today's biopharmaceutical industry is patient services. As ease of accessing HCP prescribed medications has become more difficult, the ability of a company to build, design, implement, and run dynamic end-to-end patient support offerings has become critical to patients successfully starting and staying on therapy. The role of the Director, Novartis Patient Support is to serve as a leader for product and program strategy in support of patient access to achieve product and/or portfolio objectives. This role owns ongoing planning, evaluation/measurement, and optimization of short-term and long-term program performance to enable impact for Novartis and patients. This is inclusive of end-to-end patient and provider journeys, as well as all NPS programs and services (onboarding, co-pay, adherence, e-services, hub operations, external landscape/monitoring, and shifting market dynamic). This role requires a highly collaborative and agile leader to liaise with multiple NPS Centers of Excellence and cross-functional teams, including, but not limited to, Product Strategy, Marketing, Market Access, Customer Engagement (Sales), Field Reimbursement, Ethics and Compliance, Legal, Data Analytics, and Training. Finally, this role is accountable for driving strong business performance in conjunction with other members of the NPS team. This position will be located at the East Hanover site and will not have the ability to be located remotely. This position will require 20% travel as defined by the business (domestic and/ or international). Please note that this role would not provide relocation, and only local candidates will be considered. About the Role Key Responsibilities:<ul><li>Lead a core team of cross-functional NPS stakeholders with a focus on launching new brand, managing ongoing patient support program including refinement and measurement specific to the post-prescription experience in partnership with Program Data Insights and Analytics Center of Excellence (starting and staying on appropriate therapy) </li><li>Serve as NPS subject matter expert on immunology portfolio and provide key inputs to Portfolio Strategy & Lifecycle Management Center of Excellence for program designs related to onboarding, co-pay, adherence, e-services, and hub operations to ensure reconciliation with product P&L and objectives</li><li>Drive integration of NPS priorities and program performance with identified product priorities, strategies and KPIs</li><li> Support the development of marketplace and competitive landscape assessments to inform future state of NPS support required for the Immunology portfolio </li><li> Collaborate with training, NPS Centers of Excellence, field reimbursement, market access and NPS Manager Program Operations to provide input into field reimbursement team training </li><li>Liaising with NPS Enterprise Intelligence and Insights team to gather insights on external and competitive benchmarking, scanning global best practices and liaising across network internal resources (marketing, sales reps, patient coordinators, reimbursement managers) </li><li>Supports successful implementation of any new services launched/administered for NPS including planning, managing, budgeting and launching along with ensuring adequate staffing for operational support</li><li> Oversee the creation of patient access and reimbursement content and resources in partnership with NPS Content Development Center of Exce llence to support field execution of to support field execution of Immunology patient support p rograms </li></ul> Education (minimum/desirable): Bachelor's Degree, (PharmD, RN or MBA a plus) Essential Requirements:<ul><li>7+ Pharma commercial experience, with 3 of those years of experience operating in patient services space and/or market access is required</li><li>Proven success in Hub Services</li><li>Ability to connect commercial, financial, and clinical perspectives to develop enhanced value messages and strategies</li><li>Comprehensive understanding of access journey for a patient with ability to diagnose issues and impact across comprehensive set of channel participants and vendors</li><li>Strong written and verbal communication skills, including comfort level with senior management presentations</li><li>Strong experience with sales force communication </li><li>Proven track record leading across cross-functional teams</li></ul>Preferred Experience:<ul><li>In depth knowledge of specialty product distribution and service company business models </li><li>In-depth knowledge and understanding of patient services challenges and opportunities </li><li>Experience with specialty/buy and bill products</li><li>Home office marketing experience </li><li>Previous consultant or vendor experience</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 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, NPS Program Strategy & Management

Summary This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Shift: Weekend Day Shift. This position may involve mandatory overtime as needed Production Technicians play an active role in daily production of Radioligand Therapies (RLT) as well as setup and preparation of instruments and equipment. The Production Technician adheres to regulatory requirements while performing job functions, executing production as per batch records and SOPs. Responsibilities are performed within a team and according to an assigned production shift schedule. The Production Technician works closely with the Manager and Lead to ensure production is executed in a safe and timely manner. About the Role Key Responsibilities:<ul><li>Executes all activities related to the manufacturing of RLT products. Responsibilities include operating and maintaining grade A isolators, focusing on KPI goals as well as ensuring all state, federal and Novartis radiation safety guidelines are adhered to.</li><li>Responsible for successful on-time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.</li><li>Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators. Conducts routine and dynamic environmental monitoring as required.</li><li>Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure. </li><li>Ensures all cGMP compliance activities are followed.</li><li>Participation in assigned qualification/validation activities, and assist on deviation investigations and inspections, as necessary.</li><li>Prepares applicable documents and records such as batch records, shipping documents, and training materials.</li></ul>Essential Requirements:<ul><li>Bachelor's degree in relevant Engineering or Scientific discipline is highly preferred; If the applicant does not have a degree, a minimum of 1+ year' of experience in cGMP or aseptic environment is required.</li><li>Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing is highly preferred.</li></ul><ul><li>Ability to gown aseptically and work in a clean room environment (Grade C) area for extended periods of time is required.</li><li>Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.</li><li>Ability to lift or carry up to 35 pounds</li><li>Radio Pharma experience preferred.</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 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.

2 X Production Technician, Weekend Days

Summary This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Shift: Weekend Days - position may involve mandatory overtime as needed As a Manufacturing Specialist you will provide front line support to manufacturing, working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions. About the Role Major accountabilities: <ul><li> Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed. </li><li> Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers. </li><li> Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs. &bull; Authoring/Owning investigations related to material transfer, isotope manufacturing, and packaging. </li><li> Ensure processes remain inspection ready at all times. </li><li> Support process optimization and new technology introduction for continued productivity improvement, as appropriate. </li><li> Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects. </li><li> Provide guidance and support to production team through training and knowledge sharing. </li><li> Will demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures. </li><li>Participation in assigned qualification/validation activities, as necessary.</li><li>Facilitates a culture of speaking up" and ensuring all cGMP compliance activities are followed.</li><li>Prepares applicable documents and records such as batch records, shipping documents, and training materials.</li><li>Participates in periodic mandatory overtime to ensure process continuity and completion.</li><li>Other duties may be assigned, as necessary.</li><li>Ensure overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)</li></ul>Essential Requirements: <ul><li>Bachelors degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.</li><li> Training in radiochemistry or radio pharmacy is preferred. </li><li> 3+ years' experience in a process support shop floor role in GMP manufacturing and/or QA/QC. </li><li> Strong awareness of quality issues. Compliance investigations experience required. </li><li> Good understanding of manufacturing and validation requirements and activities. </li><li> Exploitation of new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes. </li><li> Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing. </li><li> Proficient in MS Office applications. </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 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.

Manufacturing Specialist (weekend day shift)

Summary This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Shift: Weekend Nights - position may involve mandatory overtime as needed As a Manufacturing Specialist you will provide front line support to manufacturing, working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions. About the Role Major accountabilities: <ul><li> Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed. </li><li> Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers. </li><li> Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs. &bull; Authoring/Owning investigations related to material transfer, isotope manufacturing, and packaging. </li><li> Ensure processes remain inspection ready at all times. </li><li> Support process optimization and new technology introduction for continued productivity improvement, as appropriate. </li><li> Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects. </li><li> Provide guidance and support to production team through training and knowledge sharing. </li><li> Will demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures. </li><li>Participation in assigned qualification/validation activities, as necessary.</li><li>Facilitates a culture of speaking up" and ensuring all cGMP compliance activities are followed.</li><li>Prepares applicable documents and records such as batch records, shipping documents, and training materials.</li><li>Participates in periodic mandatory overtime to ensure process continuity and completion.</li><li>Other duties may be assigned, as necessary.</li><li>Ensure overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)</li></ul>Essential Requirements: <ul><li>Bachelors degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.</li><li> Training in radiochemistry or radio pharmacy is preferred. </li><li> 3+ years' experience in a process support shop floor role in GMP manufacturing and/or QA/QC. </li><li> Strong awareness of quality issues. Compliance investigations experience required. </li><li> Good understanding of manufacturing and validation requirements and activities. </li><li> Exploitation of new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes. </li><li> Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing. </li><li> Proficient in MS Office applications. </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 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.