Sr. Manufacturing Associate, cGMP Manufacturing

Sumitomo Pharma•Morrisville, NC

About The Position

The Senior Manufacturing Associate is an individual contributor in Sumitomo Pharma America’s cGMP Manufacturing organization. The role supports the safe, compliant, and reliable execution of regenerative medicine manufacturing operations, including facility start-up, routine production, and operational readiness for clinical and commercial products. The associate serves as a manufacturing subject-matter expert on the manufacturing floor, executing and troubleshooting GMP processes, supporting process validation, and leading manufacturing documentation activities. The position works closely with Quality, Engineering, Supply Chain, and other cross-functional partners to maintain inspection readiness, support continuous improvement, and help ensure uninterrupted operations in accordance with company quality and compliance standards. Work takes place in a controlled cleanroom environment and requires special gowning, including a face mask. Onsite employees may be required to travel; the posting gives a North Carolina estimate of up to 10% and also states that onsite employees may travel domestically and/or internationally up to 10–25% as required.

Requirements

At least 3 years of cGMP manufacturing experience with a degree in science or a related technical discipline, or at least 5 years of cGMP manufacturing experience with a high school diploma.
Experience in aseptic operations.
Demonstrated knowledge of cGMP manufacturing principles, aseptic processing, and cleanroom operations in a regulated pharmaceutical or cell and gene therapy environment.
Ability to independently execute and troubleshoot critical manufacturing processing steps.
Understanding of GMP documentation practices, including batch records, SOPs, forms, logbooks, and data integrity requirements.
Knowledge of deviation management, CAPA, and change-control processes as they relate to manufacturing operations.
Strong problem-solving and troubleshooting skills, including assessing manufacturing issues, identifying root causes, and communicating risks and solutions.
Effective written and verbal communication skills for documenting activities, authoring or revising SOPs, and collaborating with cross-functional teams.
Ability to work in a controlled or cleanroom environment and wear special gowning, including a face mask.
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 various heights.

Nice To Haves

Prior experience supporting new facility start-up and validation.
Scientific or engineering knowledge attained through a degree or certificate program.
Background in cell or tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations.
Experience with batch record execution and good documentation practices.

Responsibilities

Execute cGMP manufacturing operations supporting regenerative medicine production, including aseptic processing, material preparation, equipment operation, and in-process activities in a controlled cleanroom.
Independently execute and troubleshoot GMP manufacturing processes and coach others while ensuring compliance with approved procedures and regulatory expectations.
Support facility start-up, process validation, and ongoing production readiness by performing process runs, providing real-time feedback, and identifying opportunities to improve process robustness and efficiency.
Author, review, redline, and manage SOPs, batch records, forms, and labels, ensuring accuracy, completeness, and data integrity.
Own and support minor deviations, quality events, CAPAs, and change controls, including root-cause analysis and corrective-action implementation with Quality and Operations leadership.
Participate in continuous improvement activities, including 5S, waste walkthroughs, Kaizen events, and Lean or operational excellence initiatives.
Follow OSHA, environmental health and safety, and site-specific procedures, and identify and escalate potential risks or compliance concerns.
Train, coach, and mentor Manufacturing Associates on technical processes and GMP expectations.