Director, Drug Substance Commercial Manufacturing

The role

The Director, Drug Substance Commercial Manufacturing owns drug substance technology transfer, MSAT, manufacturing oversight, and operational excellence for assigned CDMO sites. This leader acts as the sponsor-side technical and operational owner of the DS process from transfer-in through lifecycle management.

What you will do

• Lead DS transfer to assigned CDMOs including scale-up and engineering batches
• Lead drug substance technology transfer, process validation, and lifecycle management
• Serve as technical owner of commercial peptide DS processes
• Drive process monitoring, investigations, change control, and CPV
• Provide technical leadership for CDMO development and manufacturing activities
• Author and support DS CMC documentation and regulatory submissions
• Evaluate and support CDMO selection, audits, and technical agreements
• Build, lead, and develop MSAT, manufacturing oversight, and technology transfer teams

Required qualifications

• 10+ years of relevant experience in drug substance technical operations
• 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
• Experience overseeing commercial DS manufacturing campaigns at external partners
• Deep expertise in synthetic peptide DS manufacturing
• Demonstrated experience in technology transfer, process characterization, control strategy implementation, and PPQ
• Experience driving operational excellence and continuous improvement at CDMOs or external manufacturing sites
• Strong understanding of CDMO operating models, capabilities, and commercial drivers
• Experience contributing to DS CMC documentation and supporting regulatory review
• Strong understanding of cGMP, pharmaceutical quality systems, and global DS regulatory expectations
• Proven ability to build and develop technical teams
• Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, biotechnology, or a related field

Nice to have

• Commercial launch experience
• Experience with peptide therapeutics at commercial scale
• Experience managing a multi-CDMO network
• Experience with a first product launch, global DS networks, and supply continuity planning
• Experience with minimum annual volume and take-or-pay commitments
• Hands-on plant or CDMO experience combined with sponsor-side oversight
• Experience providing sponsor oversight of CDMO process development
• 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

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.