Analytical Scientist

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 within a quality management system (i.e. GLP / GMP)
• Strong understanding of both: 
• Instrumental analysis as applied to drug substance drug product characterization
• Experience overseeing and critically evaluating CRO-generated data 
• Working knowledge of GLP / GMP analysis and regulatory expectations (e.g., ICH Q2(R2)) 
• Solid grounding in chemical kinetics and interpretation of concentration–time rate data  

Preferred Qualifications

• Experience in the development, qualification, and transfer of stability-indicating analytical methods, execution of forced degradation studies, and support of stability programs.
• Experience across multiple molecular modalities (polymers, peptides, proteins, and, small molecules) 
• Background in analytical development or QC for regulated products 
• Experience supporting IND-enabling and early/late stage GMP method validation studies for clinical programs 
• Familiarity with complex or long-acting drug delivery systems 

• • Own analytical strategy and method validation
    • Define fit-for-purpose analytical approaches for drug substance / drug product, and mechanistic studies 
    • Select appropriate assay platforms (RP-HPLC/UPLC and SEC, LC-MS, colorimetry, pH, viscosity, osmolarity, endotoxin, bioactivity, and other common USP methods.) 
    • Validate methods that define our products critical quality attributes. 
• • 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 instrument 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 Q2(R2)) 
    • 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 CMC, pharmacology, and clinical teams to interpret data correctly 
      • Provide clear recommendations based on quantitative evidence 
      • Write reports that enable cross-functional understanding of methods and results.   
• • Operate across modalities 
    • Apply consistent analytical thinking across polymers, peptides, biologics, and small molecules 
    • Ensure comparability and continuity of data across platforms and studies