Production Lead
About The Position
The Production Lead will be an integral part of bringing RayzeBio’s innovative radiopharmaceuticals to patients in need. As the Production Lead, you will play an active role in daily operations, striving to ensure the department’s culture of compliance and teamwork is upheld, and the production team is compliant with site safety requirements on the production floor. You will be responsible for assisting with oversight of the daily activities of production operators and provide feedback on their performance to Production Management as needed. As RayzeBio expands the production site and its portfolio of new products, you will support validation work for future initiatives and expansion of the production team. You will become a subject matter expert for production and support management with internal projects, scheduling, and training.
Requirements
- 4 – 6 years’ experience operating in a GMP environment, demonstrating increased responsibilities.
- Associate’s or Bachelor’s Degree in a STEM field is preferred.
- Experience operating aseptically within ISO 7/Class C strongly preferred.
- Experience with radiochemistry and/or radiopharmaceuticals strongly preferred.
- Strong knowledge of cGMP and aseptic practice.
- Knowledge of injectable and/or radiopharmaceutical drug product manufacturing.
- Excellent professional ethics, integrity, and ability to maintain confidential information.
- Well organized and detail oriented.
- Strong interpersonal communication skills.
- Motivated, adaptable, and able to work under pressure while meeting the needs of the production schedule.
- Uses AI tools to enhance individual productivity and quality of work
Responsibilities
- Provide leadership and guidance for production operators on the production floor.
- Oversee day-to-day production operations, including scheduling and upkeep of the production area.
- Ensure production personnel comply with site EHS and Radiation Safety programs and promote a culture of safety.
- Review of production technical documents (e.g., batch records, logbooks, forms, etc.) as needed.
- Author and/or revise production technical documents (SOPs, forms, etc.).
- Execute GMP manufacturing activities as needed.
- Support development, execution, and continuous improvement of the operator training program.
- Support and execute validation activities for clinical and commercial manufacturing.
- Support process improvements, both internally and cross-functionally, as opportunities present.
- Support Production Management in investigation of quality events (deviations, OOS, etc.).
- Support Production Management with coordination of external vendors and partners.
- Support department with inventory management, including cleaning supplies and personal protective equipment.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually for new hires
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
