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Manager, Manufacturing

3 months ago

Durham, United States Biogen Full time
Job Description

About This Role

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 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.

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

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.


Qualifications

Required Skills & Behaviors  

  • Leadership (champions the correct behaviors, values driven, sets & maintains culture)
  • Organization (maintaining a supportive work environment, team-development)
  • Accountability (consistency, clear understanding of roles, responsibilities, expectations)
  • Tactical (can allocate resources effectively depending on tasks at hand, according to incoming and outgoing batches/campaigns

Preferred Skills 

  • Technical/practical cell culture/fermentation experience
  • Competency in electronic systems (Oracle, CMMS, Trackwise, etc.)
  • Resourcefulness

Required Skills

Supervisor

  • Bachelor’s Degree (STEM strongly preferred) + 7 years of transferrable experience.
  • Associates’ Degree + 9 years of transferrable experience
  • High School Diploma (or equivalent certificate) + 11 years of transferrable experience


Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.