Analytical Scientist

Qualifications

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

Responsibilities

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

Apply consistent analytical thinking across peptides, biologics, and small molecules

Ensure comparability and continuity of data across platforms and studies