Director, Drug Substance Manufacturing & Tech Transfer

Kailera Therapeutics, Inc.; United States; Hybrid; USD 196,000 - 240,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Wellness stipend

Equity grants

Annual bonus

Job summary

Kailera Therapeutics, Inc. is seeking a Director of Drug Substance Commercial Manufacturing to own DS technology transfer, MSAT, and manufacturing oversight for the company’s CDMO network.

This role manages transfer-in, validation, launch readiness, CPV, and lifecycle management, with sponsor-side oversight across multiple sites. The role ensures processes and methods are implemented as approved, partners with Quality, Regulatory CMC, and Supply Chain, and leads a high-performing MSAT and

Qualifications

• 10+ years in drug substance operations with leadership in tech transfer and validation at external manufacturers
• MSAT or technical ops leadership for commercial DS manufacturing at CDMOs
• Experience overseeing commercial DS manufacturing campaigns and batch record reviews

Responsibilities

• Lead DS transfer to CDMOs with execution plan and milestones
• Oversee DS tech transfer, validation, commercialization, and lifecycle management
• Provide technical ownership of commercial DS processes across CDMOs and PPQ
• Drive CPV, CAPAs, investigations, and change control in collaboration with Quality/Regulatory
• Provide sponsor oversight of CDMO development and manufacturing activities
• Author DS CMC documents and support regulatory submissions and inspections
• Evaluate CDMO selections, audits, and external spend management
• Build and develop MSAT and manufacturing oversight teams across the network

Skills

Technology transfer

MSAT leadership

External manufacturing

Education

Bachelor’s in chemistry/engineering/biotech

Advanced degree preferred

Job description

Kailera Therapeutics, Inc. is seeking a Director of Drug Substance Commercial Manufacturing to own DS technology transfer, MSAT, and manufacturing oversight for the company’s CDMO network.

This role manages transfer-in, validation, launch readiness, CPV, and lifecycle management, with sponsor-side oversight across multiple sites. The role ensures processes and methods are implemented as approved, partners with Quality, Regulatory CMC, and Supply Chain, and leads a high-performing MSAT and