About This Role

The Manufacturing Supervisor/Sr. Supervisor will supervise Manufacturing Associates; schedule shift tasks; ensure GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; recruits; and coordinates with other departments by performing the duties listed below. The Supervisor/Sr. Supervisor is an established expert in the operation of a variety of processing equipment.  The incumbent also has proven leadership skills and is adept at leading a staff of associates in times of routine, as well as non-routine production activities. The incumbent can quickly identify deviations and potential process issues. Additionally, you are a highly detail-oriented and schedule-driven, creates a culture of disciplined execution and a high level of professionalism for their team.

What You'll Do

• 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.

Who You Are

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 Human Performance principles.

Required Skills

Supervisor

• 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 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.

Sr. Supervisor

• Bachelor’s Degree (BS/BA) from an accredited college or university in a relevant scientific or engineering discipline with 6 years of relevant experience, or an Associate Degree in the scientific or engineering discipline with a minimum of 8 years relevant experience, or a high school degree with a minimum of 10 years relevant experience.

Preferred Skills

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

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.