The QC Analytical Scientist will lead bioanalytical strategy, oversee CROs, ensure data integrity, and address complex analytical challenges for therapeutics.
We are seeking an experienced, highly quantitative scientist to lead bioanalytical strategy and quality control across a diverse portfolio of peptide, protein, and small molecule therapeutics. This individual will define analytical approaches, oversee external CROs, and ensure that all data generated are accurate, reproducible, and decision-grade.
This role is ideal for someone who combines deep knowledge of bioanalytical methods with a strong QC mindset and the ability to diagnose and resolve complex analytical challenges across multiple assay platforms.
Qualifications
- PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field
- 8–15+ years of relevant experience in biotech, pharma, or CRO environments
- Demonstrated expertise in bioanalytical method development, validation, and data interpretation
- Strong understanding of both:
- Ligand-binding assays (e.g., ELISA, MSD)
- LC-MS/MS-based quantitation (hands-on experience not required, but deep conceptual understanding is essential)
- Experience overseeing and critically evaluating CRO-generated data
- Working knowledge of GLP bioanalysis and regulatory expectations (e.g., ICH M10)
- Solid grounding in pharmacokinetics and interpretation of concentration–time data
- Experience across multiple molecular modalities (peptides, monoclonal antibodies, small molecules)
- Background in analytical development or QC for regulated products
- Experience supporting IND-enabling studies or clinical programs
- Familiarity with complex or long-acting drug delivery systems
Preferred Qualifications
- Own bioanalytical strategy
- Define fit-for-purpose analytical approaches for PK, PD, and mechanistic studies
- Select appropriate assay platforms (ligand-binding, LC-MS-based, hybrid methods)
- Lead CRO oversight
- Design and manage outsourced bioanalytical studies
- Critically review assay development, validation, and sample analysis
- Identify deficiencies in methods, data quality, or interpretation and drive resolution
- Ensure quantitative rigor and data integrity
- Evaluate calibration models, LLOQ, accuracy/precision, and assay robustness
- Detect and troubleshoot issues such as matrix effects, instability, adsorption, and assay interference
- Establish internal standards for data quality across programs
- Apply QC and regulatory principles
- Ensure methods and datasets meet GLP and regulatory expectations (e.g., ICH M10)
- Contribute to analytical sections of IND-enabling packages and regulatory filings
- Implement quality systems and documentation standards where needed
- Support cross-functional decision making
- Work closely with PK/PD, biology, and clinical teams to interpret data correctly
- Distinguish analytical artifacts from true biological signals
- Provide clear recommendations based on quantitative evidence
- Operate across modalities
- Apply consistent analytical thinking across peptides, biologics, and small molecules
- Ensure comparability and continuity of data across platforms and studies
5AM Ventures San Francisco, California, USA Office
501 2nd St, San Francisco, CA, United States, 94107
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