About This Role

The Supervisor/Senior Supervisor is responsible for providing leadership to a team of Manufacturing Associates, with focus on aseptic processing, product quality and patient safety. The Supervisor/Senior Supervisor provides support and manufacturing oversight to GMP operations in the Parenteral Filling process areas. This position supports daily manufacturing operations, manufacturing document management, equipment troubleshooting, validation activities, and may function as the area SME in various cross-functional teams. The ideal candidate will have detailed knowledge of GMP Parenteral Drug Product manufacturing in an isolator environment, as well as possess the ability to successfully engage and lead a team and collaborate with external partners, quality assurance, validation and senior leadership.

What You’ll Do

• Supervises Manufacturing Associates – observing/instructing, coaching, leading and developing their staff. Identifies technical/non-technical development gaps and implements applicable plans/objectives.
• Performs manufacturing activities per cGMPs, in an aseptic parenteral drug manufacturing facility, 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 their 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 PVRs, sampling, validation, etc.
• Reviews and approves batch related documents, deviations, investigations and SOPs 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 their areas.
• Troubleshoots operational and equipment problems, and makes recommendations. Also coordinates emergency repairs, changeovers, and preventative maintenance activities with the facilities group.

Who You Are

You have solid knowledge of the engineering and scientific principles and you understand Parenteral manufacturing operations. As a person you have the ability to influence audience and demonstrate cross functionally

Required Skills

Supervisor, Drug Product Manufacturing

• 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.
• Ability to work twelve (12) hour shifts (days) or others as assigned by management
• Good understanding of the operating principles for most aseptic drug product processing equipment.
• Solid knowledge of the engineering and scientific principles associated with their areas of responsibility.
• Understands the primary design principles for the facility (e.g. air pressure differentials, material flow, people flow, utility systems).
• Good oral and written communication skills.
• 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.

Sr. Supervisor, Drug Product Manufacturing

• 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’s Degree (AS/AA) in the scientific or engineering discipline with a minimum of 8 years relevant experience, or a High School diploma with a minimum of 10 years relevant experience.
• Ability to work twelve (12) hour shifts (days) or others as assigned by management
• Proven experience of the operating principles for most aseptic drug product processing equipment.
• Solid knowledge of the engineering and scientific principles associated drug product manufacturing in a cGMP aseptic processing facility.
• Understands the primary design principles for the facility (e.g. air pressure differentials, material flow, people flow, utility systems).
• Good oral and written communication skills.
• 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.

Why Biogen?

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.