CMC Lead Senior Manager/Associate Director (Radiopharmaceuticals)

• Oversee CMO/CDMO network for development of radiopharmaceutical therapeutics.
• Build lead and develop a team of process engineers.
• Contribute to CMC sections of regulatory filings.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
• History of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning

Requirements

• Bachelor's Degree in science, engineering, or related field required
• 5-8 years of experience within a cGMP environment in the biotech/biopharma industry concentrated within MSAT, Technical Operations, or Technical Development
• CDMO/CMO leadership experience required, internal team leadership preferred.
• Tech Transfer experience preferably advanced therapeutics and experience in tech transfer, process validation, project management, and change management
• Experience with Isotopes highly preferred.