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Director, Quality Control

Director, Quality Control

  • Raleigh-Durham, NC
  • Full Time
  • Director
Location: Raleigh-Durham, NC

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).

Description

The Quality team at Enzyvant takes pride in leading compliant and innovative approaches to the development and
commercialization of life-saving therapies. Enzyvant is building a regenerative medicine manufacturing facility in Morrisville, NC to support both commercial and research needs, and the Quality team is growing significantly. We are looking for a Quality Control (QC) Director to join our team and lead the development of the QC function at Enzyvant and in the new commercial manufacturing facility. The ideal candidate will be dedicated to excellence and high performance, passionate, innovative, and eager to work in a collaborative environment. A demonstrated track record of success in the biopharmaceutical industry and experience directing QC testing of biological or sterile commercial products is expected; experience with advanced therapies is a plus. Importantly, we seek an aspiring professional with potential and desire to grow within the company.

The successful candidate will report to the Senior Vice President of Regulatory Affairs, Quality, and Pharmacovigilance, be an integral leader of a growing Quality team, and work closely with a cross-functional development team and external partners. Given the small company and dynamic nature of the work, the successful candidate must be agile and have strong interpersonal skills, with an ability to maintain focus on efficiently advancing innovative medicines addressing rare and often fatal diseases.

Responsibilities

  • Establishes the QC Analytical and QC Micro Labs at Enzyvant’s new regenerative medicine manufacturing facility, including selecting instruments, SOP development, equipment qualification, method transfer, and method validation / verification processes.
  • Hires and leads a Quality Control staff responsible for raw material and finished product release, stability (as applicable), in-process testing, and Environmental Monitoring testing.
  • Leads assay transfer activities from Analytical Development and external laboratories.
  • Ensures delivery of accurate and timely data to support development and release of investigational and commercial product.
  • Manages team to ensure subject matter expertise is instilled to develop scientists’ motivation, education, efficiency, and performance.
  • Responsible for all systems, processes, metrics, and resources for Quality Control.
  • Coordinates GMP testing with outside testing labs and manages external testing labs to meet product and regulatory requirements
  • Partners with Manufacturing, Supply Chain, Quality Assurance, and Engineering to maintain raw material inventory, support validation activities, and timely batch release.
  • Reviews and supports GMP compliance on OOS, OOT, deviations, and investigations.
  • Partners with Quality Assurance Department to monitor, improve, and sustain an effective and efficient quality management system.

Qualifications

  • B.S. / M.S. in chemistry, biological or pharmaceutical sciences, or related discipline with at least 5 years QC management experience and 10+ years related experience.
  • Demonstrated growth and responsibility in management and leadership.
  • Expert level knowledge of drug product and raw material release and stability testing, industry expectations, methods, and systems for pharmaceutical products.
  • Experience with a wide variety of compendial methods such as endotoxin, sterility and other microbiological assays.
  • Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, FDA/EMA, and ICH.
  • Knowledge of current best practices and industry standards for biologics manufacturing and analysis, including commercial laboratory capabilities.
  • Broad experience directing QC testing of biological or sterile commercial products; CDMO and / or experience with advanced therapies (eg, cell, gene, or tissue) is a plus.

Contact us for more information