Director, Production
Bristol Myers Squibb
11 days ago
On-site
Indianapolis, IN
Operations
The Director, Production directs the day-to-day production activities to achieve corporate objectives at the site. Oversees and leads a team of production personnel to deliver quality finished radiopharmaceutical products on time and per the production schedule. Works with Director, Operations to ready the site for scalability toward commercialization and expanded pipeline products.
Job Responsibilities
- Provide leadership and direction to production team members.
- Collaborate with other functions for triage of deviations, investigations, and CAPAs.
- Represent production for internal/external technical transfer of future projects.
- Collaborate with Project Management to ensure schedule adherence.
- Assist Director, Operations with mentoring and development of key team members.
- Align with Isotope Production leadership to ensure GMP compliance.
- Partner with Quality, Validation, Engineer Services, and Facility Engineering to develop/implement novel radiopharmaceutical technologies.
- Work with EM/Microbiology to ensure contamination control and timely response to OOT/OOS.
- Develop/manage production performance metrics.
- Assist with production-related budgeting.
- Ensure compliance with site EHS and Radiation Safety; promote a safety culture.
- Review/author/revise technical documents (SOPs, forms, deviations, etc.).
- Up to 15% travel required.
Education and Experience (Required)
- 10+ years manufacturing experience in a cGMP injectable or Radiopharmaceutical environment.
- Proven production leadership/management; experience creating/managing production metrics.
- Working knowledge of ERP/EQMS (or similar).
- BS or MS in a related technical field.
Skills/Qualifications
- Leadership/personnel management; strong injectable/radiopharmaceutical manufacturing knowledge.
- Ethics/integrity; organized/detail-oriented; strong time management and communication.
- Motivated, adaptable, able to work under pressure.
- Leverages AI to drive program/portfolio/functional performance through prioritization and scaled adoption.
Job Responsibilities
- Provide leadership and direction to production team members.
- Collaborate with other functions for triage of deviations, investigations, and CAPAs.
- Represent production for internal/external technical transfer of future projects.
- Collaborate with Project Management to ensure schedule adherence.
- Assist Director, Operations with mentoring and development of key team members.
- Align with Isotope Production leadership to ensure GMP compliance.
- Partner with Quality, Validation, Engineer Services, and Facility Engineering to develop/implement novel radiopharmaceutical technologies.
- Work with EM/Microbiology to ensure contamination control and timely response to OOT/OOS.
- Develop/manage production performance metrics.
- Assist with production-related budgeting.
- Ensure compliance with site EHS and Radiation Safety; promote a safety culture.
- Review/author/revise technical documents (SOPs, forms, deviations, etc.).
- Up to 15% travel required.
Education and Experience (Required)
- 10+ years manufacturing experience in a cGMP injectable or Radiopharmaceutical environment.
- Proven production leadership/management; experience creating/managing production metrics.
- Working knowledge of ERP/EQMS (or similar).
- BS or MS in a related technical field.
Skills/Qualifications
- Leadership/personnel management; strong injectable/radiopharmaceutical manufacturing knowledge.
- Ethics/integrity; organized/detail-oriented; strong time management and communication.
- Motivated, adaptable, able to work under pressure.
- Leverages AI to drive program/portfolio/functional performance through prioritization and scaled adoption.