Director/Sr. Director, Analytical Development/Quality Control
Skills
- Technical leadership in analytical development for small molecules
- Hands-on experience with method development, qualification, and validation
- CDMO and contract testing lab management
- Thorough knowledge of cGMP, quality systems, ICH guidelines and regulatory requirements (FDA/EMA)
- Experience with stability testing and specification setting
- Strong written and verbal communication and presentation skills
- Cross-functional collaboration with development, manufacturing, and regulatory teams
- Project and people management, including mentoring and performance oversight
- Willingness to travel to external vendor sites as needed
Responsibilities
- Serve as analytical technical lead for multiple small molecule programs across development stages
- Develop strategies and oversee execution of analytical activities for drug substance and drug product
- Lead analytical method development, transfer, qualification, and validation
- Manage in-process, release, and stability testing and set appropriate specifications
- Oversee analytical and QC activities at CDMOs and contract testing laboratories
- Author, review, and approve development/stability reports, specifications, SOPs, and regulatory documentation
- Provide technical guidance and mentorship to internal team members and foster a culture of scientific rigor and accountability
- Communicate program progress to internal and external stakeholders via reports and presentations
- Travel to CDMOs for vendor assessment, troubleshooting, qualification, and oversight as required
Education
- Ph.D. in Analytical Chemistry or related field (required)
- Extensive industry experience (see qualifications) in pharmaceutical/biotech analytical development and quality control
Benefits
- Competitive salary
- Comprehensive health, dental, and vision insurance
- Retirement savings plan (401k) and potential employer match
- Equity/stock options (typical for private biotech)
- Paid time off and holidays
- Professional development and training opportunities
Average salary estimate
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terremoto biosciences is a covalent drug discovery and development engine creating highly targeted, small molecule medicines with unmatched selectivity, potency and efficacy. the company leverages the power of lysine-based covalency across the dis...
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