Vice President, CMC Development and Drug Delivery Innovation
Benefits
Unlimited PTO
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About the Role:
- Lead CMC strategy and execution for Kailera's portfolio of GLP-1-based therapies, including injectable and oral formulations.
- Serve as a key member of Technical Operations leadership, partnering with Regulatory, Quality, Clinical, and Commercial.
Key Responsibilities:
- Own drug substance, drug product, device, and combination product development from late-stage clinical through commercial readiness.
- Direct device development, human factors engineering, and compliance with global standards such as ISO 11608 and 21 CFR Part 4.
- Oversee regulatory submissions and interactions with health authorities globally.
Who You Are:
- A hands-on leader with 15+ years of CMC leadership experience and a track record of building and scaling technical teams.
- An expert in injectable combination products and oral solid dose development, with a deep understanding of regulatory requirements.
Why Kailera:
- Be part of a bold, mission-driven team developing therapies for obesity and related conditions.
- Enjoy comprehensive benefits, flexible time off, equity grants, and a collaborative, inclusive culture.
Kailera Therapeutics
Kailera Therapeutics is a late clinical-stage biotechnology company advancing a pipeline of GLP-1-based therapies for obesity and related conditions, including injectable and oral candidates in global trials. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence as it scales toward commercial launch.