Global Senior Director, Drug Substance Manufacturing

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

Job summary

Kailera Therapeutics in Waltham, MA, is seeking a Senior Director, Drug Substance Commercial Manufacturing. You will own DS technology transfer, MSAT, and manufacturing oversight across the Kailera CDMO network, from transfer-in and validation through launch, CPV, and lifecycle management.

This role partners with CMC Development, Analytical, and Quality to ensure processes are approved and executed. Lead a global DS manufacturing program, manage budgets and external spend, oversee PPQ and

Qualifications

• 12+ years in drug substance technical operations with leadership
• Experience leading global DS manufacturing and CDMO partnerships
• Strong cGMP, QA systems, and regulatory readiness knowledge

Responsibilities

• Own DS technology transfer, MSAT, and manufacturing oversight across CDMOs
• Lead CPV, PPQ, lifecycle management, and regulatory readiness efforts
• Develop and execute DS strategy with VP Commercial Manufacturing
• Coordinate with Quality, Regulatory, CMC Development, Analytical, Supply Chain, and PMO
• Build and develop MSAT and manufacturing oversight teams
• Manage DS budgets, external spend, and strategic investments

Skills

DS operations leadership

MSAT leadership

Technology transfer

CPV & PPQ

CDMO governance

Regulatory readiness

Budget management

Cross-functional collaboration

Process validation

Project management

Executive stakeholder mgmt

Manufacturing strategy

Education

Bachelor’s degree in chemistry/chemical engineering/pharma sciences

Advanced degree preferred

Job description

Kailera Therapeutics in Waltham, MA, is seeking a Senior Director, Drug Substance Commercial Manufacturing. You will own DS technology transfer, MSAT, and manufacturing oversight across the Kailera CDMO network, from transfer-in and validation through launch, CPV, and lifecycle management.

This role partners with CMC Development, Analytical, and Quality to ensure processes are approved and executed. Lead a global DS manufacturing program, manage budgets and external spend, oversee PPQ and