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 within a quality management system (i.e. GLP / GMP)
Strong understanding of both:
Instrumental analysis as applied to drug substance drug product characterization
Experience overseeing and critically evaluating CRO-generated data
Working knowledge of GLP / GMP analysis and regulatory expectations (e.g., ICH Q2(R2))
Solid grounding in chemical kinetics and interpretation of concentration–time rate data
Preferred Qualifications
Experience in the development, qualification, and transfer of stability-indicating analytical methods, execution of forced degradation studies, and support of stability programs.
Experience across multiple molecular modalities (polymers, peptides, proteins, and, small molecules)
Background in analytical development or QC for regulated products
Experience supporting IND-enabling and early/late stage GMP method validation studies for clinical programs
Familiarity with complex or long-acting drug delivery systems
Own analytical strategy and method validation
Define fit-for-purpose analytical approaches for drug substance / drug product, and mechanistic studies
Select appropriate assay platforms (RP-HPLC/UPLC and SEC, LC-MS, colorimetry, pH, viscosity, osmolarity, endotoxin, bioactivity, and other common USP methods.)
Validate methods that define our products critical quality attributes.
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 instrument 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 Q2(R2))
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 CMC, pharmacology, and clinical teams to interpret data correctly
Provide clear recommendations based on quantitative evidence
Write reports that enable cross-functional understanding of methods and results.
Operate across modalities
Apply consistent analytical thinking across polymers, peptides, biologics, and small molecules
Ensure comparability and continuity of data across platforms and studies
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.
We believe in building balanced teams. We are an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected characteristics.