Senior Director, Drug Substance Manufacturing & MSAT

Kailera Therapeutics, Inc.; Waltham (MA); Hybrid; USD 241,000 - 295,000; Full time

Benefits offered by this job

Health coverage

Wellness stipend

401(k) match

Equity grants

Tuition reimbursement

Commuter benefits

Paid holidays

Annual bonus opportunities

Job summary

Kailera Therapeutics, Inc. seeks a Senior Director, Drug Substance Commercial Manufacturing to lead DS operations across a network of CDMOs.

You will own technology transfer, MSAT, manufacturing oversight, and lifecycle management from transfer to launch and CPV, ensuring quality and compliance. The role reports to the VP, Commercial Manufacturing and coordinates with CMC Development, Regulatory, Quality, and Supply Chain across the Kailera network.

Qualifications

• 12+? (omitted)

Responsibilities

• Drives DS results and aligns with organizational goals
• Leads MSAT and manufacturing oversight across CDMOs
• Oversees DS technology transfer, process validation, and lifecycle management
• Author and support DS CMC documentation and regulatory interactions
• Evaluate and support CDMO selection and external spend
• Build and develop MSAT teams and cross-functional partnerships

Education

Bachelor’s in chemistry/engineering/pharma

Advanced degree preferred

Job description

Kailera Therapeutics, Inc. seeks a Senior Director, Drug Substance Commercial Manufacturing to lead DS operations across a network of CDMOs.

You will own technology transfer, MSAT, manufacturing oversight, and lifecycle management from transfer to launch and CPV, ensuring quality and compliance. The role reports to the VP, Commercial Manufacturing and coordinates with CMC Development, Regulatory, Quality, and Supply Chain across the Kailera network.