Director, Drug Substance Manufacturing & Tech Transfer — Remote/Hybrid

Kailera Therapeutics; Waltham (MA); Hybrid; USD 196,000 - 240,000; Full time

Job summary

Kailera Therapeutics in the United States is seeking a Director, Drug Substance Commercial Manufacturing to lead DS technology transfer, MSAT, and manufacturing oversight within Kailera's CDMO network. Responsibilities span from transfer-in and validation through launch, CPV, and lifecycle management, with sponsor-side leadership across multiple sites.

The role requires extensive DS experience, CPV, regulatory readiness, and strong cross-functional collaboration with QA, Regulatory, CMC, and

Qualifications

• 10+ years in drug substance operations with leadership for tech transfer.
• MSAT/DS operations in CDMOs including CPV and lifecycle changes.
• Experience overseeing commercial DS manufacturing campaigns with external partners.
• Deep expertise in synthetic peptide DS manufacturing and purification.
• Experience with PPQ, tech transfer, control strategies, and regulatory readiness.
• OpEx improvements and governance for external sites.
• Experience with DS CMC documentation and regulatory submissions.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead DS transfer to CDMOs with plan, milestones, risks through PPQ and launch.
• Oversee DS tech transfer, validation, commercialization, and lifecycle management.
• Serve as technical owner of commercial peptide DS processes and performance.
• Drive process monitoring, investigations, CAPAs, and CPV.
• Provide technical leadership for CDMO development and manufacturing activities.
• Author DS CMC docs and support regulatory submissions and inspections.
• Evaluate CDMO selection, audits, and external spend management.
• Build and develop MSAT and manufacturing teams with cross-functional partnerships.

Skills

MSAT experience

Technology transfer

Process validation

CDMO oversight

Regulatory coordination

Leadership

Communication

Strategic thinking

Education

BSc Chemistry

MS/PhD preferred

Job description

Kailera Therapeutics in the United States is seeking a Director, Drug Substance Commercial Manufacturing to lead DS technology transfer, MSAT, and manufacturing oversight within Kailera's CDMO network. Responsibilities span from transfer-in and validation through launch, CPV, and lifecycle management, with sponsor-side leadership across multiple sites.

The role requires extensive DS experience, CPV, regulatory readiness, and strong cross-functional collaboration with QA, Regulatory, CMC, and