Senior Associate Scientist, Automation - Analytical Development – Cell & Gene Therapy, Vaccines
Your job alert was successfully created.
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Associate Scientist, Automation - 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 - Automation, Analytical Development – Cell & Gene Therapy, Vaccines will be responsible for development and automation of assays used in clinical development of cell and gene therapeutics.
• Development, qualification, validation and transfer of analytical methods.
• Drive efficiencies; incorporate automation into new and existing methods.
• Writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups
• Writing analytical sections of regulatory submissions that support regulatory filings including INDs and BLAs
• Provide technical support to QC laboratories, and assist in investigations
• Accurately capturing of data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected.
• Shift work may be required.
• Bachelor's degree in Biology, Immunology or other relevant scientific field, with at least 4 years of industry experience or an MS with 2 years of experience.
• Knowledge of basic immunology techniques is required, such as mammalian cell culture and cell-based assays, ELISA, PCR, and flow cytometry.
• Experience in operation, programming, and basic troubleshooting of liquid handling platforms or integrated systems, such as Tecan, Hamilton, Beckman Coulter, Agilent/Velocity11
• Hands-on experience with CAR-T or other cell and gene therapy products or vaccines is preferred.
• Experience with analytical method development for cell-based bioassays, binding assays and/or residual impurity assays is preferred.
• Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters is helpful.
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.
Janssen Research & Development, LLC (6084)