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Manufacturing Operations Leader

2 months ago

Somerville, New Jersey, United States AbbVie Full time
Job Summary

The Manufacturing Supervisor role offers a dynamic opportunity to lead and train a team of operating personnel in the production of clinical or commercial products. By ensuring accurate documentation and adherence to cGMP standards, you will play a vital role in maintaining product quality.

Key Responsibilities
  • Develops weekly goals and schedules and sets 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.
  • Monitors operator training files and works 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 the technology transfer team to incorporate new processes in the plant.
  • Works inter-departmentally 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.
Requirements
  • Requires a Bachelor's degree or equivalent: 8+ years experience in all aspects of GMP manufacturing/packaging processes.
  • Computer proficiency and scheduling experience are required, as well as good writing skills.
  • Working knowledge of safety, quality systems, and cGMP Manufacturing packaging and or required.
  • Sterile/aseptic clean room is preferred.
  • Cell/Gene Therapy is preferred.
  • Quality Control experience is a plus.
  • Familiarity with equipment and facilities validation.
  • At least 5 years of leadership/management experience including managing production personnel.
  • Confidence in MS Office to include Word, Teams, and Excel.