Director, Drug Substance Commercial Manufacturing

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.

What You’ll Do:

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 new processes for Kailera, the role provides sponsor oversight of that work.

The role leads the MSAT and manufacturing oversight team and the day-to-day relationship with each CDMO. This role works closely with CMC Development and Analytical, who retain decisions on process development and on analytical methods and specifications. This person ensures the agreed processes and methods are implemented at the CDMO exactly as approved, with no unapproved changes. They coordinate with peer DS leaders to keep process knowledge, controls, and analytical performance consistent across the network, and partners with Quality, Regulatory CMC, Drug product, Supply Chain, and the Project Management Office (PMO).

Required location:
Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

• Lead DS transfer to assigned CDMOs: process knowledge packages, equipment and facility fit assessments, scale-up, engineering batches, and transfer acceptance criteria. Translate network DS strategy into an execution plan with milestones, resources, and risks through PPQ, registration, and launch
• Lead drug substance (DS) technology transfer, process validation, commercialization, and lifecycle management across CDMO partners, ensuring successful scale-up, PPQ execution, regulatory approval, launch readiness, and continuous supply
• Serve as the technical owner of commercial peptide DS processes, providing oversight of manufacturing operations, process performance, yield, quality, robustness, control strategies, and continuous improvement initiatives
• Drive process monitoring, comparability assessments, investigations, change control, CAPAs, and continued process verification (CPV), partnering closely with Quality, Analytical, CMC Development, Regulatory, and Supply Chain functions
• Provide technical leadership for CDMO development and manufacturing activities, including process transfers, method implementation, campaign readiness, deviation management, risk mitigation, capacity planning, and operational governance
• Author and support DS CMC documentation, regulatory submissions, inspection readiness activities, and health authority interactions, ensuring alignment between manufacturing execution and regulatory commitments
• Evaluate and support CDMO selection, audits, technical agreements, process changes, capacity strategies, business continuity planning, and external spend management
• Build, lead, and develop…