Senior Scientist , Functional Biocharacterization & Impurities

Responsibilities:

• Serve as a subject matter expert in development of cell-based assay formats for early and late phase biologics programs.
• Lead a team to implement method development and phase-appropriate validation for cell-based assays across formats.
• Supervise and develop direct reports; mentor and train junior staff.
• Transfer methods to Quality Control laboratory.
• Author technical documents.
• Participate in process development teams (potentially as potency lead and analytical team lead).
• Execute comparability and biosimilarity assessments.
• Lead technology development to improve throughput, efficiency, and onboard new technologies.
• Author and contribute to regulatory filing documents (IND, INDa, BLA, IMPD).
• Present data to internal teams, clients, conferences, and peer-reviewed journals.
• Lead cross-functional teams and initiatives.

• PhD (3+ years), MS (5+ years), or BS (10+ years) in Biochemistry, Molecular/Cellular Biology, Chemical Engineering, Bioengineering, Chemistry, or related.
• Understanding of ICH/USP guidelines for analytical and potency assay development/validation.
• Experience in development and phase-appropriate validation of potency and methods.
• Experience managing and mentoring direct reports.
• Strong understanding of link between Mechanism of Action and analytical method development; effects of impurities on biological manufacturing.
• Technology development experience relevant to potency assays (e.g., FcgR effector function assays, large-scale cell banking, image/flow cytometry).
• Strong oral and written communication; ability to thrive in fast-paced, collaborative environments.

• Experience with Soft Max Pro, JMP, and Microsoft Office.
• Experience with late-stage regulatory filings.