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Director, Analytical Development and Quality Control; Fully Remote
Remote / Online - Candidates ideally in
Jacksonville, Duval County, Florida, 32099, USA
Listed on 2026-10-30
Jacksonville, Duval County, Florida, 32099, USA
Listing for:
Kailera Therapeutics, Inc.
Full Time, Remote/Work from Home
position Listed on 2026-10-30
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
- 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 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.
We are looking to fill the Director, Analytical Development and Quality Control (Fully Remote) position at Kailera Therapeutics, Inc. in United States.
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