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
The Director, Drug Substance Commercial Manufacturing will own Drug Substance (DS) technology transfer, Manufacturing Science and Technology (MSAT), manufacturing oversight, and Operational Excellence (OpEx) for assigned CDMO sites in Kailera’s CDMO network. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Hands-on experience in MSAT or technical operations for commercial-stage DS manufacturing at CDMOs, including CPV, troubleshooting, and lifecycle change management
- Experience overseeing commercial DS manufacturing campaigns at external partners, including batch record review, deviation response, and recovery of at-risk supply
- Deep expertise in synthetic peptide DS manufacturing, including synthesis, purification, impurity control, scale-up, and process troubleshooting
- Demonstrated experience in technology transfer, process characterization, control strategy implementation, and PPQ
- Experience driving operational excellence and continuous improvement (yield, cycle time, cost, robustness) at CDMOs or external manufacturing sites
- Strong understanding of CDMO operating models, capabilities, capacity constraints, and commercial drivers, with experience establishing governance and managing external partner performance
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.
The Director, Drug Substance Commercial Manufacturing will own Drug Substance (DS) technology transfer, Manufacturing Science and Technology (MSAT), manufacturing oversight, and Operational Excellence (OpEx) for assigned CDMO sites in Kailera’s CDMO network. Reporting to the Vice President, Commercial Manufacturing, this leader is the sponsor-side technical and operational owner of the DS process at those sites, from transfer-in and validation through launch, routine commercial supply, continued process verification (CPV), and lifecycle management. Where an assigned CDMO is also developing...
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