

Sr. Scientist, Analytical Development
Actalent
02/22/2022
Posting ID: JP-002663157
Description:
The Analytical Development Senior Scientist will be responsible for development and establishment of analytical assays to be used in the characterization and evaluation of our viral vector and cell product. Candidates are expected to demonstrate the ability to design and conduct critical analytical assays using techniques with cell culture, flow cytometry, molecular biology, virology, and chemical analyses. The Analytical Development Senior Scientist will support activities involving projects and documentation performed internally and externally relating to the evaluation of our viral vector and cell product platforms. This support includes assay and protocol development for vector and cell characterization, killing/phagocytosis, chemical analyses, and vector and cell-based potency assays.
The candidate is expected to also perform routine and custom assays, review results, and aid in validation/qualification.
Responsibilities:
Responsible for resource management and initiating timely resource planning based on production forecasts and business needs
Help to establish the growing Analytical Development laboratory, including parameters related to facilities, instruments, processes, and procedures
Manage projects in collaboration with other team members, both internally and at external contract development and manufacturing organizations, to evaluate and implement new analytical and process technologies to develop next generation Cell and Gene Therapeutics
Lead, schedule, and execute laboratory studies for development, optimization, and manufacturing of vector and cell product including design, planning, execution, analysis, and reporting
Execute analytical method for validation/qualification and perform routine testing using analytical techniques for cell culture, flow cytometry, killing/phagocytosis, molecular biology, virology, chemical analyses, and vector and cell-based potency assays
Write and conduct routine assays in compliance with Carisma Standard Operating Procedures
Manage samples inventory, raw materials, and reference standards.
Participates in investigations related to assay failures, system deficiencies, deviations, equipment, and assay troubleshooting
Participates in transferring methods and procedures for new assignments as required
Participate in the batch record review process, including escalation of issues and maintain timelines for reporting
Author and review protocols, technical reports, regulatory source documents and memos to summarize experiments and support investigations
Support Regulatory submissions and Quality Assurance with technical content and expertise
Appropriately analyze data, interpret results, maintain and review laboratory notebook and logbook; prepare and deliver presentations at team meetings
Interact with internal cross-functional team members including Research, Process Development, Quality Control, Manufacturing, Nonclinical, Clinical, Quality Assurance, Regulatory, and Legal
Work effectively in a team environment to meet project timelines and objectives
Occasional travel may be required
Perform other duties as assigned
***VIROLOGY EXPERIENCE REQUIRED***
Skills:
cell based assay, vector, characterization, killing/phagocytosis, ELISA, HPLC, cell culture, potency assay, virus, Digital PCR, Infectivity
Top Skills Details:
cell based assay,vector,characterization,killing/phagocytosis,ELISA,HPLC,cell culture,potency assay,virus,Digital PCR,Infectivity
Additional Skills & Qualifications:
A degree in biology, biochemistry, chemical/bioengineering, cell biology, immunology, virology, or related discipline and
BS with 6+ years of relevant experience
MS with 4+ years of relevant experience
PhD with 1+ years of relevant experience
Biopharmaceutical industry experience preferred, in analytical assay development, GLP/GMP testing facility, or research and discovery
Proficient in target specific primer and probe assay design, blast, and alignment
A strong background in several of the following areas of expertise: cell culture, potency assays, infectivity assays, cell-based analytical methods, flow cytometry, killing/phagocytosis, MSD, ELISAs, qPCR, ddPCR, and other molecular based assays, HPLC and other physical/chemical-based technologies with expectations for significant expertise in developing, optimizing and qualification or validation of assays
Proven ability to critically analyze data and interpret results
Experience authoring and reviewing written records of work in the form of laboratory notebooks (paper or electronic)
Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, interpersonal skills, and a helpful team spirit
Able to read, comprehend, and make appropriate alterations to documents such as batch records, SOPs, etc
Proficiency with Microsoft Excel and statistical analysis software for analyzing and presenting data
Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees
Effective personal organization and time management skills
Highest moral and ethical integrity
A desire and willingness to learn, adaptability, and a “can do” attitude
Preferred:
Experience in development of potency panel assays for viral vector and cell product
Knowledge and understanding of current Good Manufacturing Practices (cGMP
Experience Level:
Expert Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Contact Information
Recruiter: Jean Chambers
Phone: (410) 579-3072
Email: jchambers@careercircle.com