Overview In this role you will advance cell-based potency assays for biopharmaceutical development, ensuring robust validation and successful tech transfer to testing labs. You will collaborate with biology SMEs to implement GMP-compatible methods and maintain data integrity in regulated environments. The work supports early to late-phase development and manufacturing, contributing to safer, scalable medicines. You will operate at the intersection of science, automation, and quality to accelerate asset delivery for patients.
Responsibilities- Develop and validate cell-based bioassays for characterization
- Participate in early/late-phase validation and method transfer to commercial labs
- Provide MOA-focused input for method development
- Collaborate with biology SMEs to ensure GMP-compatible methods
- Ensure compliance with regulatory standards, data integrity, safety and quality
- Identify and address compliance issues; independently manage experiments
- Design, execute and record experimental data; troubleshoot and propose improvements
- Collaborate with data science and automation teams
- Maintain good internal/external relationships within Analytical Development
Key requirements- Ph.D. or Master's degree in Biology, Biological Science or Molecular Biology with 2+ years of relevant experience, or Bachelor's degree with 5+ years in cell-based potency methods
- 2+ years in cell biology, including cell-based method development and troubleshooting
- 2+ years of cell culture experience with immortalized cell lines
- excellent communication
- strong technical writing
- collaboration and teamwork
- cell-based potency methods
- GMP/GLP familiarity
- flow cytometry / FACS (plus)
