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Manager, cGMP Manufacturing

Manager, cGMP Manufacturing

  • Raleigh-Durham, NC
  • Full Time
  • Manager
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 Dainippon Pharma Co., Ltd.)

Description

The Manager, cGMP Manufacturing role will ensure initiatives related to production readiness and compliance are optimized and executed appropriately in the areas of GMP production. This role will be expected to work both independently as well as with cross functional team members to achieve success. The Manager, cGMP Manufacturing will report to the Manufacturing Site Head. This role will begin as Monday-Friday and will transition to a 2-2-3 shift work schedule in approximately 2 years.

 

Responsibilities

  • Hire and develop a high-performing, flexible manufacturing team (approximately 10 operators) capable of meeting the manufacturing operation timeline.
  • Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized for training and to manufacture RETHYMIC and future clinical programs for on time delivery.
  • Oversee the training, development, retention, and performance of staff for the execution of manufacturing operations.
  • Closely partner with QA peers for  creation of SOPs, closure of documentation, inclusive of training records, deviations, batch records and CAPAs, required for timely disposition of batches.
  • Ensure smooth production operations through proactive scheduling and planning of activities
  • Lead efforts in scheduling personnel for follow-up and emergency production work.
  • Responsible for ensuring alarm monitoring, response, and reconciliation is performed in a timely fashion.
  • Attend and actively participate in waste walkthroughs, 5S, Gemba walkthroughs, kaizen events, or any other operations, lean six-sigma, quality, safety, or environmental training/initiatives, as required.
  • Coach operators in high quality deviation write-ups and appropriate CAPA development/effectiveness checks; drives manufacturing deviations to on-time closure and works with team to assure minimal deviations.
  • Support regular operation of manufacturing facility and responds to issues as needed.
  • Prepare for and successfully participate in internal audits and FDA inspections.
  • Prioritizes the work of others.
  • Other duties as required

 

Qualifications

 

  • A minimum of 5 years of relevant experience working in the pharmaceutical, biopharmaceutical, regenerative medicine, or medical device industry is required.
  • Minimum 2 years of management or cross functional project management experience in a professional setting
  • Previous experience working in ISO 7 & 8 cleanrooms along with isolators is preferred.
  • Experience at an FDA approved or late-stage cGMP manufacturing site
  • Experience in production batch record review, investigation of deviations, root cause analysis, effective CAPA development, good documentation practices and change control management
  • Experience delivering consistently prompt, efficient, dependable, highly skilled service to multiple stakeholders
  • Bachelor’s degree in science or engineering, or a degree in a relevant technical trade, is required.

Skills

  • Requires clear communication to cross functional peers daily.
  • Ability to build strong, open and collaborative working relationships with both internal and external stakeholders.
  • Sound knowledge of current Good Manufacturing Practices.
  • Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation, and initiative required.
  • Strong oral/written technical communications and leadership skills required.
  • Ability to work well with all levels of company personnel.
  • Ability to work independently with minimal supervision.
  • Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.
  • Problem solving experience providing consistent judgment, quality, accuracy, speed, and creativity.
  • Takes initiative in making improvement suggestions to promote operational goals.

Enzyvant is committed to maintaining a safe and productive workplace and work experience for our team members. As part of these ongoing efforts to the extent permitted by applicable law, Enzyvant requires all employees to be fully vaccinated against COVID-19, and this position requires that you be fully vaccinated against COVID-19 prior to your start date, as a condition of employment. If you are unable to be vaccinated, we will consider requests for reasonable accommodations in accordance with applicable legal requirements.

Contact us for more information