Job Details

ID #11830857
State North Dakota
City Researchtrianglepark
Job type Full-time
Salary USD TBD TBD
Source Biogen
Showed 2021-04-04
Date 2021-03-29
Deadline 2021-05-28
Category Et cetera
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Head of Manufacturing, Gene Therapy Operations

North Dakota, Researchtrianglepark 00000 Researchtrianglepark USA

Vacancy expired!

Job Description

About This Role

Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Head of Gene Therapy Manufacturing leads and directs all cross-functional I departmental activities associated with Gene Therapy Manufacturing operations. This role provides operations leadership and strategy in all areas of Gene therapy production to ensure an uninterrupted supply of quality products to our patients within the Biogen global drug supply network. This role will also be a member of the Gene Therapy Site Leadership Team.

What You’ll Do

  • Provide leadership to ensure a high level of communication and coordination between the production operations and the support departments to address issues and meet production schedules
  • Lead a multi-faceted team through start-up to licensure, covering Microbial Plasmid expression, Mammalian based production phase and Gene Therapy final fill operations
  • Establish and refine an operational vision that ensures the highest standards of employee safety and environmental protection, the highest standards of compliance and overall operational excellence
  • Ensure that the key start up milestones are being met
  • Develop near and long-term strategy and plans associated with new process introductions, facility utilization and manufacturing flexibility
  • Build organizational and operational capability to meet the needs of the business
  • Lead the manufacturing team position during regulatory audits
  • Embody the Biogen core behaviors, leadership competencies and provide thoughtful and high-quality leadership to the Gene Therapy Team

Who You Are

You are a strategic leader that influences business outcomes with high quality manufacturing decisions. You are dedicated to contributing to the generation of pioneering gene therapies.

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Qualifications

Education

  • University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines

Required Skills

  • Typically requires 12-15 years'experience in pharmaceutical or biotech manufacturing environment
  • Prior experience with facility construction and Biotech operations
  • Proficiency with manufacturing and business processes associated with automation and integration of novel production systems
  • Strong Communication and stake-holder management skills
  • Prior experience with Gene Therapy operations or live virus vaccine manufacturing.
  • Strong GxP knowledge

Preferred Skills

  • Prior experience in Gene Therapy Manufacturing operations and startups is preferred

Additional Information

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.

Vacancy expired!

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