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
Preferred Qualifications
- 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
- 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
$140,000 - $170,000 a year
Final compensation will be based on a candidate's qualifications, experience, and geographic location. Employees are also eligible for performance bonuses, equity participation and comprehensive health benefits.
