Manager, cGMP Manufacturing
Company: Enzyvant Therapeutics
Posted on: January 27, 2023
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
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.)
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.
- Hire and develop a high-performing, flexible manufacturing team
(approximately 10 operators) capable of meeting the manufacturing
- 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,
- 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
- Prioritizes the work of others.
- Other duties as required
- 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
- 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.
- Requires clear communication to cross functional peers
- 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
- 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
- Problem solving experience providing consistent judgment,
quality, accuracy, speed, and creativity.
- Takes initiative in making improvement suggestions to promote
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.
Keywords: Enzyvant Therapeutics, Cary , Manager, cGMP Manufacturing, Executive , Morrisville, North Carolina
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