Analytical Scientist

About the role

The Scientist/Senior Scientist, Analytical Sciences is responsible for the development, optimization, qualification, validation, and execution of analytical methods supporting raw materials, in-process, intermediate, and finished product testing for cell therapy products. This role plays a key part in advancing analytical strategies from early development through commercialization, ensuring compliance with FDA and ICH guidelines.

Responsibilities

• Design, develop, optimize, qualify, validate, and execute analytical methods for product characterization and release.
• Lead and/or support development of cell-based bioassays, potency assays, immunophenotyping, and multiplexed protein assays.
• Perform routine testing to support development studies and clinical batch release.
• Track, trend, and statistically analyze data to evaluate method performance and support specification setting.
• Advance analytical methods from concept through qualification and transfer to Quality Control and external partners.
• Apply Quality by Design (QbD) and Design of Experiments (DOE) principles to method development.
• Support scale-up and commercialization of analytical methods.
• Manage outsourced testing activities when needed.
• Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams.
• Present scientific data and serve as subject matter expert (SME) for analytical methods.
• Lead or mentor junior scientists and assist in training on analytical methods.
• Support and contribute to departmental and organizational initiatives.
• Maintain, calibrate, and operate laboratory equipment and instrumentation.
• Ensure proper documentation and organization of experimental data.
• Participate in equipment qualification and upkeep.

Qualifications

• Bachelor’s degree in biological sciences, biochemistry, chemistry, cell biology, or a related field with 7-10+ years of relevant industry experience, OR Master’s degree in a related field with 5-8+ years of experience, OR PhD in a related field with 2-5+ years of experience.
• 10+ years of experience preferred, particularly within GMP/CMC or other regulated environments and spanning development through commercialization.
• Experience supporting clinical and commercial development of pharmaceutical, biological, or cell therapy products, including scale-up to commercialization.
• Hands-on experience with analytical method development (e.g., immunoassays, multi-parameter flow cytometry, cell-based potency assays) in a QC or regulated setting preferred.