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 StatesLead💰 $196,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in drug substance technology transfer, MSAT, and manufacturing oversight, with a strong focus on operational excellence and regulatory compliance. Proven ability to lead technical teams, manage external partnerships, and drive continuous improvement in commercial-stage drug substance manufacturing.

Highest-signal resume keywords

Drug Substance Technology TransferMSAT LeadershipProcess ValidationSynthetic Peptide ManufacturingCGMP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Technology TransferProcess ValidationCPVTroubleshootingProcess CharacterizationControl Strategy ImplementationOperational ExcellenceBatch Record ReviewDeviations ManagementRegulatory Submissions

Soft Skills

Stakeholder ManagementCommunicationScientific JudgmentBusiness Acumen

Industry Keywords

CDMOPharmaceutical Quality SystemsAnalytical RequirementsGlobal Regulatory ExpectationsContinuous Improvement

About the role

Key responsibilities & impact

Own drug substance technology transfer, MSAT, manufacturing oversight, and operational excellence for assigned CDMO sites
Serve as the sponsor-side technical and operational owner of drug substance processes from transfer-in and validation through launch, routine commercial supply, CPV, and lifecycle management
Lead the MSAT and manufacturing oversight team and manage day-to-day relationships with CDMOs
Ensure approved processes and analytical 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, and the PMO
Lead process knowledge packages, equipment and facility fit assessments, scale-up, engineering batches, transfer acceptance criteria, PPQ, registration, and launch planning
Oversee manufacturing operations, process performance, yield, quality, robustness, control strategies, and continuous improvement
Drive process monitoring, comparability assessments, investigations, change control, CAPAs, and CPV
Provide technical leadership for CDMO development and manufacturing activities, campaign readiness, deviation management, risk mitigation, capacity planning, and operational governance
Author and support drug substance CMC documentation, regulatory submissions, inspection readiness, 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

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 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
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