Job Description

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

QC Analytical Scientist

QC Analytical Scientist - 5AM Ventures

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