Production Lead, Weekend Nights

Novartis•Indianapolis, IN

About The Position

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.

Requirements

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.
4+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing preferred.
Good understanding of manufacturing and validation requirements and activities.
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 should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.
Makeup, jewelry, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
Ability to lift or carry up to 35 pounds.

Nice To Haves

Training in radiochemistry or radio pharmacy is preferred.
Exploitation of new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes.

Responsibilities

Executes all activities related to the manufacturing of RLT isotope products.
Responsibilities include operating and maintaining grade C isolators, focusing on KPI goals as well as ensuring all state, federal and Novartis radiation safety guidelines are adhered to.
Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators.
Conducts routine and dynamic environmental monitoring as required.
Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
Participation in assigned qualification/validation activities, as necessary.
Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed.
Prepares applicable documents and records such as batch records, shipping documents, and training materials.
Participates in periodic mandatory overtime to ensure process continuity and completion.
Ensures technicians complete all required training in accordance with published curriculum.
Participate in technician professional development counselling to foster a growth culture.
Other duties may be assigned, as necessary.