Director, Drug Substance Tech Transfer & Manufacturing

Kailera Therapeutics; United States; Remote; USD 250.000 - 350.000; Vollzeit

Zusammenfassung

Kailera Therapeutics is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The Director will own drug substance (DS) technology transfer, MSAT, and manufacturing oversight for CDMOs, serving as the sponsor-side technical lead for commercial DS processes.

You will lead process validation, commercialization, and lifecycle management, driving process monitoring, investigations, and continuous improvement across CDMOs.

Qualifikationen

• 10+ years in DS technical operations with leadership experience.
• Deep expertise in synthetic peptide DS manufacturing and cGMP.

Aufgaben

• Lead process validation, commercialization, and lifecycle management across CDMOs.
• Drive process monitoring, investigations, and continuous improvement.

Kenntnisse

Leadership experience

DS technical operations

cGMP knowledge

Jobbeschreibung

Kailera Therapeutics is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The Director will own drug substance (DS) technology transfer, MSAT, and manufacturing oversight for CDMOs, serving as the sponsor-side technical lead for commercial DS processes.

You will lead process validation, commercialization, and lifecycle management, driving process monitoring, investigations, and continuous improvement across CDMOs.