Production Lead, Weekend Nights

Production Leads play an active role in daily production of isotope manufacturing as well as setup and preparation of instruments and equipment. The Production Lead adheres to regulatory requirements while performing job functions, executing production as per batch records and SOPs. Responsibilities are performed within a team and according to an assigned production shift schedule. The Production Lead works closely with the Shift Supervisor and Production Manager to ensure production is executed in a safe and timely manner.

• Execute all activities related to the manufacturing of RLT isotope products.
• Operate and maintain grade C isolators, focusing on KPI goals and ensuring all state, federal, and Novartis radiation safety guidelines are adhered to.
• Ensure successful, on‑time completion of required training curriculum comprising the necessary SOPs, techniques, gowning qualifications, and other relevant training, including HSE for the specific role.
• Support all technical aspects related to production readiness, including manual cleaning of the cell and performing sterilization of the isolators.
• Conduct routine and dynamic environmental monitoring as required.
• Prepare all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
• Participate in assigned qualification/validation activities, as necessary.
• Facilitate a culture of “speaking up” and ensure all cGMP compliance activities are followed.
• Prepare applicable documents and records such as batch records, shipping documents, and training materials.
• Participate in periodic mandatory overtime to ensure process continuity and completion.
• Ensure technicians complete all required training in accordance with the published curriculum.
• Participate in technician professional development counselling to foster a growth culture.
• Other duties may be assigned as necessary.

• Bachelor of Science strongly preferred; if the applicant does not have a degree, a minimum of 2 years of experience in a cGMP or aseptic environment can be substituted.
• Training in radiochemistry or radio pharmacy preferred.
• 4+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing preferred.
• Good understanding of manufacturing and validation requirements and activities.
• Ability to exploit new technology and techniques to eliminate non‑value‑adding activities and improve productivity via new processes.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Near‑vision performance of 20/20 with no impairment of color vision; corrective lenses permitted.
• Prohibition of makeup, jewelry, nail polish, perfume/cologne, and other potential microbial sources in restricted areas.
• Ability to lift or carry up to 35 pounds.

Shift: Weekend days, 12 hours

Seniority level:
Mid‑Senior level

Employment type:

Full‑time

Job function:
Management and Manufacturing

Industries:
Pharmaceutical Manufacturing