Scientist, Bioanalytical Assay Development - APPLICANTS MUST HAVE DIRECT ADA (ANTI DRUG ANTIBODY) DEVELOPMENT, QUALIFICATION, AND/OR VALIDATION EXPERIENCE AND ADA SAMPLE TESTING EXPERIENCE
6 - 10 years
South San Francisco, CA
Full-time
Onsite
2 months ago
About the role
Scientist, Bioanalytical Assay Development - APPLICANTS MUST HAVE DIRECT ADA (ANTI DRUG ANTIBODY) DEVELOPMENT, QUALIFICATION, AND/OR VALIDATION EXPERIENCE AND ADA SAMPLE TESTING EXPERIENCE
Position Summary
This is an opportunity for a hands-on bioanalytical scientist to join the ground floor of an early-stage (~20 people), highly funded, stealth-mode biotech company. Backed by premier investors with years of secure financial runway, the company originated in Switzerland and is now anchoring in San Francisco. The organization merges biomolecular computing, AI, and gene therapy to completely redesign how medicine is created.
The cutting-edge platform utilizes computational logic circuits delivered systemically via AAV to detect and destroy cancer cells with unprecedented precision. As the company builds its path to the clinic and prepares for IND-enabling studies, they are seeking a nimble, low-ego, fast-learning "utility player" to fill a critical gap on the team.
The successful candidate will work closely with an internal Bioanalytics lead and receive hands-on mentorship and world-class coaching from a premier industry Consultant in the field.
Key Responsibilities
ADA & Immunogenicity Focus
Bioanalytical & Biomarker Development
Hands-on Sample Testing
CRO Management
Cross-Functional Agility
Required Qualifications (Non-Negotiable):
Preferred Qualifications (Nice-to-Have):
- Location: San Francisco, CA (Onsite)
- Compensation: $100,000 – $125,000 base (depending on experience) + Significant Equity (No bonus)
- Position Type: Full-Time, Direct Hire
Position Summary
This is an opportunity for a hands-on bioanalytical scientist to join the ground floor of an early-stage (~20 people), highly funded, stealth-mode biotech company. Backed by premier investors with years of secure financial runway, the company originated in Switzerland and is now anchoring in San Francisco. The organization merges biomolecular computing, AI, and gene therapy to completely redesign how medicine is created.
The cutting-edge platform utilizes computational logic circuits delivered systemically via AAV to detect and destroy cancer cells with unprecedented precision. As the company builds its path to the clinic and prepares for IND-enabling studies, they are seeking a nimble, low-ego, fast-learning "utility player" to fill a critical gap on the team.
The successful candidate will work closely with an internal Bioanalytics lead and receive hands-on mentorship and world-class coaching from a premier industry Consultant in the field.
Key Responsibilities
ADA & Immunogenicity Focus
- Design, develop, characterize, and validate complex in vitro assay methods to detect and characterize immune responses (ADA, Luminex) evoked by novel biotherapeutics.
- Lead the characterization of immune responses (Immunogenicity).
Bioanalytical & Biomarker Development
- Develop and verify transbiomarker and quantitative analyte assays to measure transgene expression levels across various biological matrices.
Hands-on Sample Testing
- Directly execute on-site sample analysis for non-clinical studies.
- Perform regression analysis, establish validated statistical cutpoints, construct standard curves, and interpolate sample concentrations/antibody titers.
CRO Management
- Act as the primary technical point of contact for external CRO partners to outsource, validate, and transfer bioanalytical methods for GLP-regulated and early-phase clinical studies.
- Manage external CROs to ensure seamless assay transfers for GLP-regulated studies.
Cross-Functional Agility
- Work independently within a nimble, fast-paced environment, managing timelines and collaborating across various in vivo and research workstreams to support upcoming IND filings.
Required Qualifications (Non-Negotiable):
- Direct, hands-on experience with Anti-Drug Antibody (ADA) assay development, qualification, or validation. (Please note: ADA assay experience is mandatory; standard ELISA experience alone is insufficient).
- Strong Immunology background with a deep understanding of characterizing immune responses / immunogenicity.
- Proven experience managing CROs for assay transfers, validation, and sample testing.
- Industry Experience: A minimum of 3–5+ years of relevant biotech/pharma industry experience in a drug development setting.
- Education: BS, MS, or Ph.D. in Immunology, Biochemistry, or a related scientific discipline.
- Platform Expertise: Proficiency with state-of-the-art platforms such as MSD, ELISpot, and Luminex.
Preferred Qualifications (Nice-to-Have):
- Direct experience working with Antibody-Drug Conjugates (ADCs) or oncology therapeutics.
- Specific expertise with AAV or gene therapy therapeutic development.
- Exposure to or familiarity with early-phase clinical trials and IND-enabling study requirements.
Skills
Science and Research