Quality Control Analyst

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.

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field
• 5 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