Analytical Scientist

• 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 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 (LC, 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