Director, Production- Pharmaceutical Manufacturing

Job Responsibilities

• Provide leadership and direction to members of the production team including manager(s), supervisor(s), operator(s), and associate(s).
• Collaborate with other functional areas for the triage of deviations, investigations, and CAPAs.
• Represent production for the internal and external technical transfer of future projects.
• Collaborate with the Project Management team to assure production schedule adherence.
• Assist the Director, Operations in mentoring and development of key members of the production team.
• Align with leadership on the Isotope Production team to ensure GMP compliance and synergy across all operations at the site.
• Work with Quality, Validation, Engineer Services and Facility Engineering counterparts to successfully develop and implement novel radiopharmaceutical technologies.
• Work with EM/Microbiology team to ensure contamination control strategies are followed and any OOT or OOS issues are addressed in a timely manner.
• Develop and manage production related performance metrics.
• Assist the Director, Operations with production-related budgeting.
• Ensure production personnel comply with site EHS and Radiation Safety programs and promote a culture of safety.
• Review, author and/or revise technical documents (SOPs, forms, deviations, etc.) as needed.
• 10 years’ manufacturing experience in a cGMP injectable or Radiopharmaceutical environment is required.
• Proven production leadership and management experience.
• Demonstrated experience creating and managing production related metrics.
• Working knowledge of industry related electronic systems (ERP, EQMS, etc.)
• BS or MS Degree in a related technical field.