Supervisor, Manufacturing (Harvest - Large Scale Manufacturing)

  • Full-time
  • Region: US
  • Department: Manufacturing

Job Description

This position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on either a day, night, or hybrid shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments.

Major responsibilities for this role include but are not limited to:

  • 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. This includes providing updates to production schedulers, and working closely with quality control, materials management, manufacturing sciences, validation, facilities, process engineering, and quality assurance, etc. to ensure execution of PPRs, sampling, validation, etc.
  • 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. Also 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

Qualifications

Bachelor’s Degree (BS/BA) from an accredited college or university in a relevant scientific or engineering discipline with 4 years of relevant experience, or an Associate’s Degree (AS/AA) in the scientific or engineering discipline with a minimum of 6 years relevant experience, or a High School diploma with a minimum of 8 years relevant experience.

Good understanding of the operating principles for large scale 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 Hu principles.

  • Prior experience in Biologics Manufacturing operations
  • Ability to work in a continuous operation environment (7 day a week/ days, nights or hybrid shift)
  • Excellent oral and written communication skills.
  • Able to multi-task.
  • Practical knowledge and application of GMP regulations.
  • Detail-oriented person with exceptional documentation practices.
  • Good process knowledge with expertise in multiple biotech production unit operations.

Additional Information

This position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on either a day, night, or hybrid shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments.

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