Responsible for the daily supervision and training of operating personnel in the production of clinical or commercial products. Works in concert with other supervisors. Responsible for the accurate and timely completion of production related cGMP documentation. Facilitates the transfer, planning,
implementation, and maintenance of manufacturing processes and procedures. Ensures the effective use of material, equipment, and personnel in producing quality products.
- Develops weekly goals and schedules and set priorities for staff. Reviews weekly production schedule and priorities to determine unit assignments and critical actions.
- Reviews all materials and batch records required to support shift and any off shift needs for the day.
- Provides on the floor training to support formalized technical and GMP training. Check that operator training files match and support the processes they are required to carry out.
- Monitors operator training files and work with compliance specialist to keep files up to date.
- Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Reviews new Batch records and SOPs.
- Works with technology transfer team to incorporate new processes in the plant.
- Works interdepartmentally to see that work orders, dispensing, preventative maintenance, QC, and documentation issues are resolved and enhances communications at all levels.
- Ensures that direct materials budgets and overtime budgets are met.
- Provides supervision primarily to skilled nonexempt and junior level exempt employees. Acts as advisor to unit or sub-unit, becomes actively involved as required. Acts as mentor for less senior personnel.
- Evaluates staff performance.
- Bachelor’s degree required with eight plus years’ experience or equivalent, in all aspects of manufacturing/ production processes
- Chemical Engineering degree required
- Computer proficiency and scheduling experience required
- Good writing and communication skills.
- Working knowledge of safety, quality systems, and cGMPs is required
- Familiarity with industrial automation (e.g., distributed control, PLC-based systems, and Delta V)
- Familiarity with equipment and facilities validation
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced