Production Lead, External Manufacturing

  • Cambridge, MA
  • Full-time
  • Department: Manufacturing
  • Region: US

Job Description

About This Role

In this role you will work under the coordination of a Virtual Plant Manager and manage  manufacturing operations for specific product(s) at one or more CMOs.

What You’ll Do

  • Responsibilities include commercial and/or clinical supply.
  • Participate to one or several virtual plant teams. Manages a subset of product(s) with one or more CMOs.
  • Be responsible for direct communication with contract site on production and production issues.
  • Work closely with internal Biogen groups, and coordinate the corresponding virtual plant team(s) (Quality, Planning, Logistics, Sourcing, Manufacturing Sciences, and Technical Development).
  • Ensure continued supply of API / Drug Product / Finished Product as per clinical and/or commercial demand.
  • For products under your responsibility, ensure projects (product lifecycle management, technology transfers, change control etc.) are smoothly implemented at the CMO and in coordination with concerned Biogen functions.
  • Act as backup to the Virtual Plant Manager in charge of concerned CMO(s).

Qualifications

Required Skills

  • Bachelors Degree.
  • Minimum 2 - 4 years of experience In biotech/pharmaceutical cGMP manufacturing industry.
  • Some experience in project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams.
  • Good negotiation skills.
  • Manufacturing experience in other modalities is a plus.
  • English fluent

Preferred Skills

  • Master Degree (Life Science, Quality, Engineering), additional competences in Business Administration, Supply Chain or related fields.
  • Experience with supplier relationships.
  • Experience with either biologics and oral solid dosage manufacturing including a mix of parenteral filling, API, oral solid dosage and finished products manufacturing.

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.

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