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Senior Manager, cGMP Manufacturing

Senior Manager, cGMP Manufacturing

  • Durham, NC
  • Full Time
  • Senior Manager/Supervisor

Description

The Pharmaceutical Development & Manufacturing Team drives the efficient execution of goals that enable development, commercialization and cGMP compliant manufacture of products in the Enzyvant portfolio. Working cross-functionally and with high visibility across the organization, the Sr Manager of cGMP Manufacturing will be responsible for CMO operations support and planning, sample management, and CMC vendor management. Reporting directly into the VP of Pharmaceutical Development & Manufacturing, the Senior Manager will maintain focus on responding to the needs of project teams and patients in a highly dynamic, fast-moving regenerative medicine environment.

You will:

  • Lead cGMP manufacturing support of commercial activities at Enzyvant’s CMO and testing laboratories.
  • Drive high production throughput in partnership with the QA and CMO Team.
  • Support manufacturing investigations, as needed, and ensure the timely review and closure of deviations
  • Utilize technical expertise and industry knowledge to author and critically review manufacturing batch records, SOPs, protocols, reports, and other relevant technical documents.
  • Lead improvement initiatives across the supply chain and manage projects related to commercial launch readiness.
  • Be an active and helpful member of project teams.
  • Drive and support continuous process verification and process performance monitoring program for products.
  • Collaborate with External Partners to achieve business goals and to establish a common culture that benefits both our company and external partners.

Qualifications

  • BS or MS in a scientific or engineering field with a minimum of 5 years of experience in the pharmaceutical or a related industry
  • Experience applying cGMPs to manufacturing operations; creative, innovative, self-motivated individual with a solid base in engineering fundamentals and process troubleshooting
  • Must demonstrate integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence
  • Excellent organizational skills and ability to work on multiple projects/tasks with tight timelines
  • Solid record of fostering open communication and building collaborative, trust-based relationships with diverse groups including CMOs, Finance, Quality, Regulatory, and Legal
  • Self-directed individual who has a can-do attitude and can work effectively in a fast-paced environment
  • Detailed oriented individual who can simplify complex problems and effectively communicate across a wide range of audiences
  • Ability to motivate a team around a common vision to deliver expected results

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