Analytical Scientist

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