QC Analytical Scientist

• 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