Manager, cGMP Manufacturing

Sumitomo Pharma•Morrisville, NC

1d•Onsite

About The Position

The Manager, cGMP Manufacturing will ensure production readiness and compliance initiatives are optimized and executed appropriately in GMP production at Sumitomo Pharma America’s manufacturing facility in Morrisville, North Carolina. The role leads a manufacturing team of approximately five operators and supports production of RETHYMIC and future clinical programs, with responsibility for on-time delivery, staff development, efficient use of resources, and smooth production operations. The manager works closely with Quality Assurance and other stakeholders on procedures, training and batch documentation, deviations, CAPAs, and timely batch disposition. The position is onsite and follows one of two shifts on a 2-2-3 schedule. Workdays Sunday through Thursday are 7:00 a.m.–7:30 p.m.; workdays Friday and Saturday are 7:00 a.m.–5:30 p.m. Weekends and holidays are required as scheduled. Onsite employees may travel domestically and/or internationally up to 10–25% of the time as required; additional travel may be required for management roles.

Requirements

At least 5 years of relevant experience in the pharmaceutical, biopharmaceutical, regenerative medicine, or medical device industry.
At least 2 years of management or cross-functional project management experience in a professional setting.
Bachelor’s degree in science or engineering, or a degree in a relevant technical trade.
Experience at an FDA-approved or late-stage cGMP manufacturing site.
Experience with production batch record review, deviation investigations, root cause analysis, effective CAPA development, good documentation practices, and change control management.
Ability to communicate clearly with cross-functional peers and build collaborative relationships with internal and external stakeholders.
Sound knowledge of current Good Manufacturing Practices.
Strong interpersonal, teamwork, adaptability, innovation, initiative, oral and written technical communication, and leadership skills.
Ability to work well with all levels of company personnel and independently with minimal supervision.
Ability to rapidly absorb technical data and apply it to a pharmaceutical manufacturing environment.
Problem-solving experience demonstrating sound judgment, quality, accuracy, speed, and creativity.
Ability to make improvement suggestions that promote operational goals.
Ability to deliver prompt, efficient, dependable, highly skilled service to multiple stakeholders.
Ability to lift and carry materials, including heavy items; stand and walk for prolonged periods; handle and operate equipment and tools; climb ladders or steps and reach for items at different heights; and work in varying temperatures and environmental conditions.
Willingness to travel domestically and/or internationally up to 10–25% as required; additional travel may be required for management roles.

Nice To Haves

Previous experience working in ISO 7 and ISO 8 cleanrooms and with isolators.
Background in cell or tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations.

Responsibilities

Hire and develop a high-performing, flexible manufacturing team of approximately five operators to meet manufacturing timelines.
Ensure people, facilities, supplies, and other resources are efficiently used for training and manufacturing RETHYMIC and future clinical programs, supporting on-time delivery.
Oversee staff training, development, retention, and performance for manufacturing operations.
Partner with Quality Assurance peers to create SOPs and close documentation, including training records, deviations, batch records, and CAPAs, for timely batch disposition.
Proactively schedule and plan activities to support smooth production operations.
Schedule personnel for follow-up and emergency production work.
Ensure alarm monitoring, response, and reconciliation are completed in a timely manner.
Participate in waste walkthroughs, 5S, Gemba walkthroughs, kaizen events, and other operations, lean six-sigma, quality, safety, or environmental training and initiatives as required.
Coach operators on high-quality deviation write-ups and appropriate CAPA development and effectiveness checks; drive manufacturing deviations to on-time closure and work to minimize deviations.
Support regular manufacturing facility operations and respond to issues as needed.
Prepare for and participate successfully in internal audits and FDA inspections.
Prioritize the work of others.
Perform other activities as required.
Maintain compliance with applicable regulatory, legal, and operational rules and procedures and uphold industry practices and ethical standards.
Maintain confidentiality of information encountered in the role.