Indianapolis, IN
Order: 110545
Pro Talent Group, a division of MS-IL Staffing & Packaging, and its local client are NOW HIRING a Director of Production in the Indianapolis, Indiana, area!
We are seeking a dedicated and experienced Director of Production to play a critical role in delivering innovative radiopharmaceutical products to patients in need. In this role, the Director of Production will report to the Director of Operations and will oversee day-to-day production activities to ensure that corporate objectives are met efficiently and effectively.
This leader will be responsible for managing and guiding a team of production personnel to achieve timely, high-quality delivery of finished products, all while adhering to the production schedule. Additionally, the Director of Production will work closely with the Director of Operations to prepare the site for scalability, as our client advances toward its commercialization goals and broadens its product pipeline.
Job Responsibilities:
· Lead and provide direction to the production team, including managers, supervisors, operators, and associates.
· Collaborate across departments to address deviations, conduct investigations, and manage CAPAs (Corrective and Preventive Actions).
· Act as the production representative for internal and external technical transfers on future projects.
· Partner with Project Management to ensure adherence to the production schedule and timely project execution.
· Support the Director of Operations in mentoring and developing key production team members.
· Align with leadership on the Isotope Production team to ensure GMP (Good Manufacturing Practice) compliance and cohesive site operations.
· Work with Quality, Validation, Engineering Services, and Facility Engineering teams to implement new radiopharmaceutical technologies successfully.
· Collaborate with the EM/Microbiology team to maintain contamination control strategies and promptly address any OOT (Out of Tolerance) or OOS (Out of Specification) issues.
· Develop and track performance metrics related to production efficiency and quality.
· Assist in production-related budgeting and financial planning with the Director of Operations.
· Ensure compliance with site Environmental Health and Safety (EHS) and Radiation Safety programs, fostering a culture of safety.
· Review, draft, and update technical documents such as SOPs, forms, and deviation reports as needed.
· Perform other duties as assigned.
Job Requirements:
· 10+ years’ manufacturing experience in a cGMP injectable or Radiopharmaceutical environment is REQUIRED.
· BS or MS Degree in a related technical field.
· Proven production leadership and management experience.
· Demonstrated experience creating and managing production related metrics.
· Working knowledge of industry related electronic systems (ERP, EQMS, etc.)
· Up to 15% of travel is REQUIRED
Skills for Success:
· Proven leadership and personnel management experience.
· Strong knowledge of injectable and/or radiopharmaceutical drug product manufacturing.
· Excellent professional ethics, integrity, and ability to maintain confidential information.
· Organized and detail oriented.
· Strong time management and organizational skills.
· Strong interpersonal communication skills.
· Motivated, adaptable, and able to work under pressure.
Physical Requirements:
· Can regularly sit, reach with hands and arms, talk or hear, and climb staris with or without accommodation.
· Can occasionally lift and/or move up to 50 pounds.
· Specific vision abilities required by this job include close vision and distance vision.