Senior Scientist, Analytical Development and Quality Control job at Kailera Therapeutics, Inc. requires a PhD with a minimum of 6 years of experience in analytical development and quality control, or equivalent experience. Responsibilities include overseeing analytical activities, ensuring data integrity, and complying with regulatory requirements.
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
