QC Analytical Scientist

Requirements

• 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

Additional Information

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.

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Company Intel

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