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Associate Director, CMC Manufacturing Sciences & Technology

Associate Director, CMC Manufacturing Sciences & Technology

  • Raleigh-Durham, NC
  • Full Time
  • Associate Director

Who We Are

Enzyvant is a commercial-stage biotechnology company on the leading edge of regenerative medicine for rare diseases. Our lead asset is FDA-approved RETHYMIC®, a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. It is an exciting time for the Enzyvant team as we deliver on our patient purpose and execute on our bold vision for growth.

Patients are the heart and soul of Enzyvant, inspiring deep meaning, passion, and purpose in our work. They are all the reasons for why, how, and what we do. At Enzyvant, we see a world where the promise of our breakthrough biotechnologies is fully realized to transform the lives of patients battling devastating rare diseases. To achieve this vision, we are pursuing new uses and geographies for our biotechnologies and providing extensive support to help families navigate the complexity of rare diseases with our Enzyvant Connect program.

The Enzyvant team includes some of the most innovative talent in the regenerative medicine sector today. We attract people in biotech who want to make their mark in regenerative medicine and deliver truly meaningful, life-changing solutions for patients. Our company culture values teamwork, innovation, empowerment, and integrity. Enzyvant has a small company feel with the reach and resources of our global parent company Sumitovant Biopharma Ltd. (wholly owned by Sumitomo Pharma Co., Ltd.)

Description

The Associate Director, CMC MS&T (Manufacturing Sciences & Technology) will establish the MS&T function at the new cGMP manufacturing facility being built by Enzyvant and support the CMO partner responsible for the production of RETHYMIC. The Associate Director reports to the Vice President, Pharmaceutical Development and Manufacturing.

Responsibilities

  • Ensure that key initiatives that bridge Development and Manufacturing are efficiently and proactively advanced and implemented through regulatory approval.  Initiatives include new drug product container, significant process changes, process validation, and comparability study design.
  • Ensure efficient cGMP processes and software systems such that the compliant delivery of product is optimizing delivery of product supply.
  • Provide support to the Enzyvant CMO partner to assure achievement of product quality and production goals.  Provide technical leadership during deviation investigations and related cGMP documentation, as necessary.
  • Contribute to risk analysis and mitigation plans to ensure product quality
  • Work closely with cross-functional teams (e.g. clinical, development, manufacturing, quality and commercial) to meet product demand and phase appropriate cGMPs.
  • Contribute to writing and review of regulatory filings.
  • Perform manufacturing trending and data analysis.
  • Utilize project management tools such as schedules, action lists, and clear scope definition to ensure the timely implementation of process improvements at CMOs and internal operations.

Minimum Qualifications

  • Minimum of 5 years of relevant pharmaceutical/biotechnology experience.
  • Advanced degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences or equivalent
  • Experience with sterile or aseptic processing, GMP manufacturing and statistical process control is required.
  • Experience with cellular or tissue culture products preferred.
  • Experience with cGMP packaging design and vendor management is preferred
  • Detailed knowledge of ICH, FDA, EMA regulations for manufacturing of biologicals
  • Experience managing suppliers and 3rd party contract organizations

Contact us for more information