Kailera is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1 therapies to provide options for people living with obesity. Backed by a16z.
About the role
Kailera Therapeutics is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1-based therapies for people living with obesity, including ribupatide (an injectable, once-weekly GLP-1/GIP dual agonist currently in global Phase 3 trials), an oral formulation of ribupatide, KAI-7535 (an oral GLP-1 receptor agonist), and KAI-4729 (an injectable GLP-1/GIP/glucagon tri-agonist). Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Working knowledge of ISO medical device standards (11608, 11040, 10993, 13485, 14971), 21 CFR Part 4, and EU MDR Article 117 requirements for combination products
- Experience with oral solid dose formulation development in addition to injectable/parenteral products
- Prior authorship and ownership of CMC sections for at least one BLA, NDA, or MAA submission, with direct experience interacting with FDA and/or other health authorities on CMC and device matters
- Proven track record building, leading, and scaling technical teams, including establishing global commercial product supply chains
- Experience managing CDMO and device supplier relationships, including technical oversight, platform evaluation, and contract/quality agreement negotiation
- A hands-on operator who is equally comfortable setting long-range CMC strategy and rolling up their sleeves on day-to-day execution in a lean, fast-moving organization
More about this role
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
Kailera Therapeutics is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1-based therapies for people living with obesity, including ribupatide (an injectable, once-weekly GLP-1/GIP dual agonist currently in global Phase 3 trials), an oral formulation of ribupatide, KAI-7535 (an oral GLP-1 receptor agonist), and KAI-4729 (an injectable GLP-1/GIP/glucagon tri-agonist).
The Vice President, CMC Drug & Device Development will own Chemistry, Manufacturing, and Controls (CMC) strategy and execution across this portfolio — spanning drug substance, drug product,...
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