Director, Drug Substance Commercial Manufacturing

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 high-performing MSAT, manufacturing oversight, and technology transfer teams while fostering strong cross-functional and external partnerships to achieve business, quality, and supply objectives

 

Required Qualifications:

• 10+ years of relevant experience in drug substance technical operations, including at least 5 years of leadership with accountability for technology transfer and process validation at external manufacturers through commercial supply
• 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
• Experience contributing to DS CMC documentation for marketing applications and supporting regulatory review for inspection readiness. Commercial launch experience is strongly preferred
• Strong understanding of cGMP, pharmaceutical quality systems, analytical and stability requirements, comparability, and global DS regulatory expectations
• Proven ability to build and develop technical teams and deliver multiple workstreams with clear priorities, budgets, and accountability
• Strong scientific judgement and business acumen, with the ability to evaluate technical evidence, communicate tradeoffs, and influence cross-functional decisions without owning every decision
• Excellent communication and stakeholder management skills; ability to travel domestically and internationally to CDMOs and company sites

 

Preferred Qualifications:

• Experience with peptide therapeutics at commercial scale
• Experience managing a multi-CDMO network with distinct quality systems and timelines
• Experience with a first product launch, global DS networks, supply continuity planning, and post-approval process improvements
• Experience with minimum annual volume and take-or-pay commitments, including assessing financial exposure and aligning operations to contractual thresholds
• Hands-on plant or CDMO experience combined with sponsor-side oversight, including person-in-plant support during commercial campaigns
• Experience providing sponsor oversight of CDMO process development alongside commercial supply
• Experience with solid-phase, solution-phase, or hybrid peptide synthesis, preparative chromatography, commercial isolation and drying
• Experience with design of experiments, statistical process evaluation, and CPV
• Lean, Six Sigma, or equivalent continuous improvement training or certification

 

Education:

• Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, biotechnology, or a related field required. An advanced degree (M.S., Ph.D., or equivalent) is preferred