Careers

Senior Associate Scientist, Logistics - Analytical Development Cell & Gene Therapy, Vaccines

Get Referred

Job Description


Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Associate Scientist, Logistics - Analytical Development Cell & Gene Therapy, Vaccines, located in Malvern, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

As a member of our team, the Senior Associate Scientist will contribute to operations and logistics supporting both method development as well as process analytical support (PAS).

Responsibilities:
• Document generation and data verification for analytical test methods, method transfer protocols and reports, qualification and validation protocols and reports as well as certificate of analysis for critical reagents.
• Contribute to regulatory filing documentation to include verification of raw data associated with in-process, comparability, release/stability testing.
• Drive efficiencies with creation and verification of templates for electronic notebooks and data generating software
• Engage with PAS and QC organizations, to provide critical reagent oversight, trending and forecasting.
• Assisting with sample management and forecasting as required.
• Instrument IO/OQ/PQ, logbook review, and general laboratory operations.
• Utilize electronic systems (LIMS, MES, LES, Empower, etc.)
• Complete laboratory investigation records, corrective and preventative actions (CAPA) and change controls.
• Execute analytical method qualification, validations and transfers as required.


Qualifications
• Bachelor's degree in biology, immunology or other relevant scientific field, with at least 3-4 years of relevant experience OR a Master’s degree with 1-2 years of relevant experience in a biologic, biopharmaceutical, or regulated pharmaceutical industry is required.
• Working knowledge of LabWare LIMS and/or other QC data systems, as well as appropriate GMP quality systems (e.g. SOPs, etc.) is required.
• Experience authoring technical documents is required.
• Familiarity with software such as Molecular Devices Softmax, BD FACs Suite preferred.
• Analytical method development in a BSL2, GxP laboratory is preferred.
• Hands on experience with analytical laboratory techniques such as flow cytometry, PCR, cell-based bioassays, ELISA is preferred.
• Technical understanding of CAR-T, virus, or other cell and gene therapy products is preferred
• This role is based in Malvern, PA and may require up to 10% of domestic travel. Shift work may be required based on business needs.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



Primary Location
United States-Pennsylvania-Malvern-
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
9371191108