Demo

Director, Production

HIRESIGMA LLC
Queens, NY Full Time
POSTED ON 5/4/2025
AVAILABLE BEFORE 5/27/2025

Title : Director of Production

Location : Indianapolis, IN

Benefits / Duration : Full-Time

Full Relocation Assistance

Must-Haves :

  • 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.

Job Description :

The Director of production is an integral part of bringing innovative drug products to patients in need. In this role, you will report directly to the Director of Operations and be primarily responsible for directing the day-to-day production activities to achieve corporate objectives at the site. The Director of Production will oversee and lead a team of production personnel to successfully deliver quality finished radiopharmaceutical products, on time, and in accordance with the production schedule. Additional responsibilities will include working with the Director of Operations in readying the site for scalability, as we work towards commercialization goals and expanded pipeline products.

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 ensure production schedule adherence.
  • Assist the Director, of Operations in mentoring and developing 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 Client 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.
  • Assist the Director, of 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
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