Manufacturing Manager (device Assembly And Packing) 12 Hr AM - OH

Manager, Manufacturing

Let's do this. Let's change the world. In this role you will be managing and leading all aspects of either a small manufacturing production area, or a section of a larger production area in an Inspection and Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed.

Specific responsibilities include but are not limited to:

• Compliance: Evaluate and approve reports and protocols. Ensure cGMP and CFR compliance of manufacturing areas. Revise, update, and review procedures. Coordinate the development and revision of SOPs. Evaluate current manufacturing procedures and recommend changes to management to optimize production. Assure all corporate change control procedures are followed, and Regulatory and QA are made aware prior to the changes. Interact with the FDA. Ensure Amgen policies are followed.
• Process/Equipment/Facilities: Ensure maintenance and re validation of systems. Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities. Develop, implement and assess solutions for problems. Responsible for resolving problems during operation. Coordinates set up of critical new manufacturing processes.
• Staff Supervision: Responsible for selection, training, evaluation, staff relations and development of staff. Ensure training programs are maintained. Ensure scheduling of production and maintenance activities. Interacts with management in optimizing organizational structure and responsibilities. Ensure plant safety through auditing and evaluations.
• Administrative: Interacts with management in planning, developing and maintaining budget. Assist in developing and maintaining department goals

Shift: This position will be supporting Second Shift 2:30pm until approximately 11:00pm. Second shift will start in May/June of 2025 and the incumbent will work a M-F first shift until that time.