Location: Indianapolis, IN
Job Summary
The Director, Production is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Director, Operations and be primarily responsible for directing the day-to-day production activities to achieve corporate objectives at the site. The Director, 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, 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 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.
- Up to 15% of travel required.
Education and Experience:
- 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.
Skills and Qualifications:
- 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 Demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear and climb stairs with or without accommodation. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
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