Senior Director, Drug Substance Manufacturing & CMC

BioSpace; Waltham (MA); Sur place; USD 217 280 - 266 750; Plein temps

Résumé du poste

A biotechnology company in Waltham is seeking a Senior Director for Drug Substance Manufacturing. The role involves leading GMP manufacturing processes, managing contracts, and ensuring compliance with regulatory standards. The ideal candidate will have at least 12 years of experience in biopharmaceutical manufacturing and strong expertise in bioconjugates. Key responsibilities include vendor management and collaboration with cross-functional teams to support clinical supply chain initiatives. Excellent communication and leadership skills are essential for success in this role.

Qualifications

• Minimum 12 years of experience in biopharmaceutical manufacturing, including CMC management.
• Proven expertise in bioconjugates and biologics manufacturing.
• Comprehensive experience with CMC regulatory submissions.

Responsabilités

• Lead GMP drug substance manufacturing and process performance qualification.
• Manage contracts and oversee suppliers involved in materials planning.
• Support QA compliance with cGMPs and guidance for clinical trial materials.

Connaissances

Bioconjugates expertise

Biopharmaceutical manufacturing

Leadership and interpersonal skills

Strategic thinking and problem-solving

Formation

Bachelor's degree in biology, biochemistry, chemistry, or related field

Advanced degree preferred

Description du poste

A biotechnology company in Waltham is seeking a Senior Director for Drug Substance Manufacturing. The role involves leading GMP manufacturing processes, managing contracts, and ensuring compliance with regulatory standards. The ideal candidate will have at least 12 years of experience in biopharmaceutical manufacturing and strong expertise in bioconjugates. Key responsibilities include vendor management and collaboration with cross-functional teams to support clinical supply chain initiatives. Excellent communication and leadership skills are essential for success in this role.