Sr. Scientist, Bioanalytical CRO Management, DMPK (Orexin Programs)

Position Summary: 

The Senior Scientist in Bioanalytical CRO Management, DMPK, partners with CROs to support the development (qualification), validation, and application of bioanalytical methods for quantifying small molecule drugs and metabolites in biological matrices. This role supports both preclinical and clinical studies and requires a strong foundation in analytical chemistry, hands-on experience with mass spectrometry and related instrumentation.  The role requires a proven ability to manage CROs to ensure that bioanalytical method development and sample analyses are executed efficiently, with a quality mindset aligned with regulatory compliance. 

Key Responsibilities: 

• Collaborate with and manage CROs for method transfer, qualification/validation, sample analysis, and data review; ensure data integrity and timely delivery
• Review statements of work (SOWs) to ensure alignment with project objectives
• Analyze and interpret bioanalytical data, ensuring accuracy and consistency and review study plans, method development summaries, validation reports, and regulatory documents (e.g., INDs, NDAs)
• Coordinate compound shipments in collaboration with CMC teams
• Track study deliverables and communicate progress to cross-functional teams and management
• Ensure compliance with GLP and other applicable regulatory guidelines.
• Write standard operating procedures (SOPs) and document key team decisions.
• Represent the DMPK function in project team meetings; present results and contribute to data-driven decision-making.
• ~10% travel to monitor CRO as needed 

Education and Qualifications: 

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
• Minimum of 4 years of industry experience in a biotech or pharmaceutical setting
• Proven experience managing CROs and overseeing external assay transfers required
• Strong analytical and problem-solving skills, with emphasis on assay sensitivity, selectivity, and reproducibility
• Hands-on experience with quantitative LC-MS/MS method development and validation for small molecule drug development
• Proficiency with LC-MS/MS instrumentation (e.g., Sciex, Waters, Thermo) and associated software (e.g., Analyst, MassLynx, Xcalibur)
• Prior experience supporting IND-enabling studies and clinical stage development programs
• Familiarity with regulatory bioanalytical guidelines (e.g., FDA, EMA, ICH M10) and GLP/GCP environments
• Demonstrated ability to work cross functionally and communicate scientific findings clearly and effectively

POSITION: Full-Time, Exempt

Work Location: This is a fully remote position open to candidates based in either the United States or the United Kingdom, with infrequent travel (less than 10%) to our headquarters in Boston, MA.