Sr. Supervisor, Manufacturing

Biogen-posted 4 months ago
$95,000 - $124,000/Yr
Full-time • Mid Level
Durham, NC
Chemical Manufacturing
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This position is on a 12-hour rotation, Night shift on a 2, 2, 3 schedule. This position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on a Night shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments.

  • Supervises Manufacturing Associates - observing/instructing, coaching, leading and developing staff.
  • Identifies technical/non-technical development gaps and implements applicable plans/objectives.
  • Performs manufacturing activities per cGMPs, ensuring that reports are fully trained on a given activity prior to performing the activity.
  • Schedules and directs daily manufacturing activities, timely communicating scheduling changes/issues to staff and management.
  • Coordinates manufacturing activities with other departments, providing updates to production schedulers, and working closely with quality control, materials management, manufacturing sciences, validation, facilities, process engineering, and quality assurance.
  • Reviews and approves batch related documents, ensuring the proper cGMP documentation practices are followed.
  • Trains manufacturing associates on process activities, including Safety requirements and cGMP requirements.
  • Reviews safety records and identifies/implements corrective measures.
  • Supervises validation activities, ensuring proper and timely execution of validation protocols required in respective areas.
  • Troubleshoots operational and equipment problems and makes recommendations.
  • Coordinates emergency repairs, changeovers, and preventative maintenance activities with the facilities group.
  • Coordinates and drafts revisions of batch related documents, including batch records and SOPs.
  • Grounded understanding of the operating principles for biologics manufacturing.
  • Solid knowledge of the engineering and scientific principles associated with designated areas of responsibility.
  • Understands the primary design principles for the facility (e.g., air pressure differentials, material flow, people flow, utility systems).
  • Basic understanding of the roles of other functional groups within the company.
  • Particularly knowledgeable on safety, GMP, and Human Performance principles.
  • Can influence through effective communication of vision and purpose.
  • Experience in a GMP pharmaceutical manufacturing facility.
  • Technical/practical experience in Purification Manufacturing.
  • Competency in electronic systems (Oracle, CMMS, Trackwise, etc.)
  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation
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