We are looking for a talented and dedicated Analytical Scientist to join our team! 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.

The position includes leading and supporting cell-based development (e.g., ELISA, flow cytometry, potency assays), evaluating new analytical technologies, and enabling method transfer to Quality Control and external partners. The role also contributes to regulatory filings through authoring and reviewing technical reports and CMC sections.

This role collaborates cross-functionally with Process Development, Manufacturing, and Quality teams, while supporting a culture aligned with company values.

Essential Duties and Responsibilities

Analytical Development & Execution

• 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.

Method Lifecycle & Technology Transfer

• 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.

Collaboration & Leadership

• 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.

Laboratory Operations

• Maintain, calibrate, and operate laboratory equipment and instrumentation.
• Ensure proper documentation and organization or experimental data.
• Participate in equipment qualification and upkeep.

Additional Responsibilities

• Contribute to risk assessments, comparability studies, and specification justifications.
• Perform other duties as required.

Education & Experience

• 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.

Working Conditions:

Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.

Must be able to lift and carry up to 20 pounds.

Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.

Disclaimer:

Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.