Manufacturing Operations Leader
4 weeks ago
AbbVie is seeking a skilled Manufacturing Supervisor to lead and train a team of operating personnel in the production of clinical or commercial products. This role offers a dynamic opportunity to ensure accurate documentation and adherence to cGMP standards, maintaining product quality and driving excellence in manufacturing operations.
The ideal candidate will have a strong background in GMP manufacturing/packaging processes, with at least 8 years of experience and a Bachelor's degree or equivalent. Computer proficiency, scheduling experience, and good writing skills are also required.
This is an onsite position in Branchburg, NJ, with a requirement for work rotatory shifts. The successful candidate will have the opportunity to collaborate with various departments, resolve issues, and incorporate new processes, contributing to the overall success of the manufacturing operations.
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 specialists to keep files up to date.
- Works with QA and Subject Matter Experts (Tech Ops or Process Sciences) to resolve exceptions and reviews new batch records and SOPs.
- Works with the technology transfer team to incorporate new processes in the plant.
- Ensures that direct materials budgets and overtime budgets are met.
- Provides supervision primarily to skilled nonexempt and junior-level exempt employees.
- Evaluates staff performance.
Qualifications:
- 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 is required.
- Sterile/aseptic clean room experience is preferred.
- Cell/Gene Therapy experience is preferred.
- Quality Control experience is a plus.
- Familiarity with equipment and facilities validation is required.
- At least 5 years of leadership/management experience, including managing production personnel.
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