Senior Director, Drug Substance Commercial Manufacturing

Kailera Therapeutics

. Own drug substance technology transfer, MSAT, manufacturing oversight, and operational excellence for assigned CDMO sites .

Posted 11/2/2026full-timeWaltham • Massachusetts • United StatesSenior💰 $241,000 - $295,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in drug substance technology transfer, MSAT, and commercial manufacturing operations, with a strong focus on process validation, operational excellence, and regulatory compliance. Proven ability to lead cross-functional teams and manage external partnerships effectively while driving continuous improvement initiatives.

Highest-signal resume keywords

Drug Substance Technology TransferMSAT LeadershipCommercial Manufacturing OperationsProcess ValidationSynthetic Peptide Manufacturing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process ValidationTechnology TransferOperational ExcellenceCPVTroubleshootingSynthesisPurificationImpurity ControlChange ManagementBatch Record Review

Soft Skills

Strong Business AcumenExcellent CommunicationStakeholder ManagementScientific JudgmentTeam Development

Industry Keywords

CGMPPharmaceutical Quality SystemsRegulatory CMCAnalytical RequirementsGlobal Drug Substance RegulationsCDMO Operating ModelsGovernanceCapacity PlanningHealth Authority InteractionsContinuous Improvement

About the role

Key responsibilities & impact

Own drug substance technology transfer, MSAT, manufacturing oversight, and operational excellence for assigned CDMO sites
Serve as sponsor-side technical and operational owner of drug substance processes from transfer-in and validation through launch, routine commercial supply, CPV, and lifecycle management
Develop and execute drug substance strategy with the Vice President of Commercial Manufacturing
Lead the MSAT and manufacturing oversight team and day-to-day relationships with multiple CDMOs
Ensure approved processes and methods are implemented at CDMOs without unapproved changes
Coordinate with peer drug substance leaders to maintain consistent process knowledge, controls, and analytical performance across the network
Partner with Quality, Regulatory CMC, Drug Product, Supply Chain, CMC Development and Analytical, and the PMO
Drive drug substance commercial manufacturing operations, supply, operational excellence, and continuous improvement
Manage commercial manufacturing budgets, external spend, and strategic investments
Lead transfers to assigned CDMOs, including process knowledge packages, equipment and facility fit assessments, scale-up, engineering batches, and transfer acceptance criteria
Lead technology transfer, process validation, commercialization, and lifecycle management across CDMO partners
Oversee commercial peptide drug substance processes, manufacturing performance, yield, quality, robustness, control strategies, and improvement initiatives
Drive process monitoring, comparability assessments, investigations, change control, CAPAs, and CPV
Provide technical leadership for CDMO development and manufacturing activities, including campaign readiness, deviation management, risk mitigation, capacity planning, and operational governance
Author and support drug substance CMC documentation, regulatory submissions, inspection readiness activities, and health authority interactions
Evaluate and support CDMO selection, audits, technical agreements, process changes, capacity strategies, business continuity planning, and external spend management
Build, lead, and develop MSAT, manufacturing oversight, and technology transfer teams

Requirements

What you’ll need

12+ years of relevant experience in drug substance technical operations
At least 8 years of leadership with accountability for technology transfer and process validation at external manufacturers through commercial supply
Strong business acumen and experience balancing technical, operational, financial, and strategic priorities
Experience leading global drug substance manufacturing operations and commercial supply strategies
Hands-on MSAT or technical operations experience for commercial-stage drug substance manufacturing at CDMOs, including CPV, troubleshooting, and lifecycle change management
Experience overseeing commercial drug substance manufacturing campaigns at external partners, including batch record review, deviation response, and recovery of at-risk supply
Deep expertise in synthetic peptide drug substance 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 at CDMOs or external manufacturing sites
Strong understanding of CDMO operating models, capabilities, capacity constraints, and commercial drivers
Experience establishing governance and managing external partner performance
Experience contributing to drug substance CMC documentation for marketing applications and supporting regulatory review for inspection readiness
Strong understanding of cGMP, pharmaceutical quality systems, analytical and stability requirements, comparability, and global drug substance regulatory expectations
Proven ability to build and develop technical teams and deliver multiple workstreams with clear priorities, budgets, and accountability
Strong scientific judgment and business acumen
Excellent communication and stakeholder management skills
Ability to travel domestically and internationally to CDMOs and company sites
Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, biotechnology, or a related field required

Benefits

Comp & perks

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability insurance
Life insurance
Annual bonus opportunities
Equity grants