Job Description
Job DescriptionSenior Scientist, Potency Assay
Location: San Diego, CA
Employment Type: Full-time
Hiring Company: BioPhase (on behalf of our client)
Pay: $145,000–$165,000 base + bonus; stock options
Hours: Monday–Friday, full-time
Job Description:
We’re seeking a Senior Scientist to develop and qualify target-binding and cell-based potency assays for protein biologics and conjugates. You’ll own assay strategy from discovery through CMC, and lead method transfer/implementation at CDMOs for lot release, stability, and characterization in support of clinical manufacturing.
Essential Duties and Responsibilities:
• Build GMP QC-compatible target engagement and cell-based potency assays for multiple modalities.
• Culture/maintain cell lines and create well-documented cell banks for assay use.
• Identify, qualify, and manage critical reagents; maintain assay readiness.
• Author/review development reports, method transfer/verification/qualification protocols, and summaries.
• Review GMP release/stability results; support OOS/OOT investigations, QC data review, and batch release at partner sites.
• Partner with CDMOs on reference standard qualification and assay lifecycle management.
• Collaborate cross-functionally to advance programs from discovery to CMC.
Qualifications:
• MS/PhD in Biology, Biochemistry, or related field.
• 5+ years’ industry experience developing potency assays.
• Hands-on expertise qualifying recombinant and cell-based assays (target binding, signaling, cytotoxicity) for GMP use.
• Proficient with data analysis tools (e.g., GraphPad Prism, SoftMax Pro).
• Strong communicator; effective with internal teams and external CDMOs.
Preferred:
• Prior CDMO collaboration and exposure to regulatory filings.
• Experience with process-related impurity testing (bioburden, HCP, residual DNA, leached Protein A).
Benefits:
Comprehensive package including medical, dental, vision, life & disability insurance; 401(k); FSA; EAP; PTO & parental leave; flexible schedule; relocation assistance; year-end shutdown.
Apply today and join our team!