Senior Scientist, Analytical Development and Quality Control

Requirements

• Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs)
• Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards
• Perform detailed review and provide data integrity oversight of data generated at CDMOs
• Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes
• Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements
• Oversee stability programs to support product retest, shelf-life, and expiration dating
• Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs)
• Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data
• Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations
• Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.)
• Work closely with Manufacturing and Quality Assurance teams to generate cGMP compliant data during product development and manufacturing
• Provide technical guidance and support to internal teams and external partners
• Oversee the preparation and review of technical documents, including protocols, reports, and SOPs
• Ensure data integrity and traceability in all analytical documentation

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants