Director, Production
Bristol Myers Squibb
11 days ago
On-site
Indianapolis, IN
Operations
Job Description
Director, Production (reports to Director, Operations) directs day-to-day production activities to achieve corporate objectives at the site. Oversees and leads a production team to deliver quality finished radiopharmaceutical products on time and per the production schedule. Supports site readiness for scalability toward commercialization goals and expanded pipeline products.
Job Responsibilities
- Provide leadership and direction to production team (manager(s), supervisor(s), operator(s), associate(s)).
- Collaborate on triage of deviations, investigations, and CAPAs.
- Represent production for internal/external technical transfer of future projects.
- Collaborate with Project Management to ensure production schedule adherence.
- Assist with mentoring and development of production team members.
- Align with leadership on Isotope Production to ensure GMP compliance and cross-site synergy.
- Partner with Quality, Validation, Engineer Services, and Facility Engineering to develop/implement radiopharmaceutical technologies.
- Partner with EM/Microbiology for contamination control; address OOT/OOS issues timely.
- Develop/manage production performance metrics; assist with production budgeting.
- Ensure compliance with site EHS and Radiation Safety; promote a safety culture.
- Review/author/revise technical documents (SOPs, forms, deviations).
- 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 and Qualifications
- Leadership and personnel management; strong injectable/radiopharmaceutical manufacturing knowledge.
- Ethics/integrity; confidentiality.
- Organized/detail-oriented; strong time management.
- Interpersonal communication; motivated/adaptable; able to work under pressure.
- Leverages AI to drive performance via prioritization and scaled adoption.
Director, Production (reports to Director, Operations) directs day-to-day production activities to achieve corporate objectives at the site. Oversees and leads a production team to deliver quality finished radiopharmaceutical products on time and per the production schedule. Supports site readiness for scalability toward commercialization goals and expanded pipeline products.
Job Responsibilities
- Provide leadership and direction to production team (manager(s), supervisor(s), operator(s), associate(s)).
- Collaborate on triage of deviations, investigations, and CAPAs.
- Represent production for internal/external technical transfer of future projects.
- Collaborate with Project Management to ensure production schedule adherence.
- Assist with mentoring and development of production team members.
- Align with leadership on Isotope Production to ensure GMP compliance and cross-site synergy.
- Partner with Quality, Validation, Engineer Services, and Facility Engineering to develop/implement radiopharmaceutical technologies.
- Partner with EM/Microbiology for contamination control; address OOT/OOS issues timely.
- Develop/manage production performance metrics; assist with production budgeting.
- Ensure compliance with site EHS and Radiation Safety; promote a safety culture.
- Review/author/revise technical documents (SOPs, forms, deviations).
- 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 and Qualifications
- Leadership and personnel management; strong injectable/radiopharmaceutical manufacturing knowledge.
- Ethics/integrity; confidentiality.
- Organized/detail-oriented; strong time management.
- Interpersonal communication; motivated/adaptable; able to work under pressure.
- Leverages AI to drive performance via prioritization and scaled adoption.