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
