Director, Analytical Development and Quality Control
Benefits
Unlimited PTO
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The Role:
- Lead analytical development and QC strategies for sterile injectable products across the product lifecycle.
- Ensure regulatory CMC readiness for IND/NDA submissions and commercial launch.
What You'll Do:
- Oversee method development, validation, transfer, stability, and external laboratory execution.
- Partner cross-functionally with QC, QA, Regulatory Affairs, Manufacturing, and CDMOs.
Who You Are:
- Bring 10+ years of pharma/biotech experience with expertise in HPLC/UPLC, LC-MS, and cGMP/ICH standards.
- Combine strong technical leadership with project management and staff mentoring skills.
Kailera Therapeutics, Inc.
Kailera is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The company is an inclusive, team-oriented workplace with an entrepreneurial spirit focused on collaboration, integrity, and excellence.