Head of Manufacturing
Responsible for overseeing Progenics manufacturing function. Oversees development of manufacturing processes and capabilities for the company developmental candidates and the flow of the organization’s commercial products through production, including the planning of production schedules, coordinating materials requirements, and formulating and recommending manufacturing policies and programs. Oversee the execution of the organization’s contract manufacturing, outsourcing and/or in-sourcing relationships and opportunities
This is a key leadership position that will interface with various functions at Progenics as well as Progenics’ partners to ensure timely and cost-effective development and manufacturing of radiopharmaceutical drugs for clinical supply and commercial launch.
The major functions to be performed in this position are as follows:
Lead in-house and outsourced activities to develop and optimize processes for Progenics’ novel therapeutics or imaging agents
Lead outsourced development and manufacturing activities for small molecule active pharmaceutical ingredients and/or precursors used in radiopharmaceutical products
Identify manufacturing and testing facilities for radiopharmaceuticals. Establish partnerships with CMOs, manage tech transfer and GMP manufacturing for clinical drug supply
Technical writing and review of CMC related regulatory documents, SOPs, Quality Events, RFPs, etc
Experience: Candidates should have a minimum of 7-10 years relevant work experience.
Knowledge and experience in the following areas:
• Manufacturing operations under cGMP compliance, aseptic processing, protein purification, process engineering, validation, technical writing, operations and maintenance of utility systems
• Experience with technetium, lutetium, indium and iodine radiopharmaceutical isotopes is highly desirable
• Ability to properly assess resources and plan accordingly
• Attentiveness to details; strong communication and coaching skills; team-oriented focus; strong planning and organization skills
• Willing to travel when needed