DS Commercial Manufacturing & Tech Transfer Leader

Kailera Therapeutics, Inc.; United States; Remote; USD 241.000 - 295.000; Vollzeit

Benefits dieser Stelle

Health coverage

401(k) match

Wellness stipend

Zusammenfassung

Kailera Therapeutics, Inc. is seeking a Senior Director, Drug Substance Commercial Manufacturing to lead tech transfer, MSAT, and manufacturing oversight across a multi-CDMO network.

This role anchors process knowledge, controls, and analytics, ensuring commercial supply aligns with regulatory commitments and lifecycle objectives. The position requires deep DS expertise, global manufacturing experience, and strong leadership with a focus on OpEx and efficiency.

Qualifikationen

• 12+ years in drug substance operations with leadership in tech transfer and validation at external manufacturers
• Strong business acumen balancing technical, operational, financial and strategic priorities
• Experience leading global DS manufacturing and commercial supply strategies
• CPV, troubleshooting, and lifecycle change management experience in MSAT or DS technical ops
• Experience with external manufacturing campaigns and transfer to CDMOs

Aufgaben

• Drive DS results contributing to organizational goals
• Lead DS commercial manufacturing operations and continuous improvement across the network
• Manage DS budgets, external spend, and investments to support growth
• Lead DS transfer to CDMOs including PPQ; ensure agreed processes are implemented
• Provide sponsor oversight of DS tech transfer, validation, commercialization, and lifecycle management
• Collaborate with Quality, Regulatory, CMC Development, Analytical, Supply Chain and PMO to align decisions
• Support CDMO selection, audits, and external partnerships
• Build and develop MSAT and tech transfer teams across the network

Kenntnisse

DS leadership

CDMO management

MSAT leadership

Regulatory readiness

Process validation

Ausbildung

Bachelor's degree in Chemistry/Engineering

Advanced degree preferred

Jobbeschreibung

Kailera Therapeutics, Inc. is seeking a Senior Director, Drug Substance Commercial Manufacturing to lead tech transfer, MSAT, and manufacturing oversight across a multi-CDMO network.

This role anchors process knowledge, controls, and analytics, ensuring commercial supply aligns with regulatory commitments and lifecycle objectives. The position requires deep DS expertise, global manufacturing experience, and strong leadership with a focus on OpEx and efficiency.