Job Details

ID #12024548
State North Dakota
City Researchtrianglepark
Job type Full-time
Salary USD TBD TBD
Source Biogen
Showed 2021-04-08
Date 2021-03-31
Deadline 2021-05-30
Category Et cetera
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Head of Manufacturing Sciences, Gene Therapy Manufacturing

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 Director ManufacturingSciences, Gene Therapy provides leadership for the Manufacturing Sciences team at the RTP Gene Therapy manufacturing facility.The Manufacturing Sciences organization is an applied science organization with strong scientific depth and technical project management. The Manufacturing Sciences team focuses on the application of best-in-class manufacturing science and technologies to deliver robust manufacturing processes, to increase process understanding and to provide options for continuous process improvements for our portfolio of gene therapy assets.

What You’ll Do

  • Direct and control, through managers in the function, the broad responsibilities of Manufacturing Sciences at the site. This includes:
    • Participation in the site leadership team, site management and site strategy
    • Clinical and commercial tech transfer, new product introductions and product re-supply support
    • Routine manufacturing support and process investigations
    • Identification of process improvements and technology advancement
  • Provide technical direction, leadership, and development to people leaders and individual contributors in the Manufacturing Sciences team of scientists and support personnel
  • Collaborate globally with directors and managers of other line functions at the site and within PO&T, as well with other members of the Global Manufacturing Sciences leadership team
  • Understand and respond to business priorities and translate into tactical objectives and work direction for the Manufacturing Sciences team. This includes process SMEs/support, laboratory operations, investigation support, and CMC/Regulatory/inspection support.
  • Ensure that asset and partner Program deliverables are met
  • Manage budget, staffing, and performance management duties for the site MS team
  • Ensure compliance with cGXP regulations and maintain a high degree of regulatory compliance with the FDA, EMA, and other agencies by contributing to and reviewing relevant sections of regulatory filings. Provide technical SME support during site regulatory inspections.

Who You Are

You have a patient first mindset, and strong interpersonal/communication skills to lead cross-functionally. You are also a strategic business leader with the ability to influence and enable execution of complex global projects.

#LI-CL1

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
  • Leadership (managing managers) and people development experience required
  • Proven track record of process development and commercialization
  • Strong program and project management skills along with analytical skills that support tracking functional area progress
  • Experience in leading larger global teams of multiple layers, enabling and empowering decisions to the right level, and leading by example for the company's core cultural behaviors

Preferred Skills

  • GMP experience working in a highly regulated environment and with regulatory agencies highly preferred
  • Direct gene therapy development/manufacturing experience preferred

Additional Information

Some Travel may be required, when able, to support global activities ( 5% travel expected)

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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