Sr. Manufacturing Associate, cGMP Manufacturing

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview:

The Senior Manufacturing Associate (Sr. MA) is a key contributor within the cGMP Manufacturing organization and plays a critical role in supporting Sumitomo Pharma America (SMPA) by ensuring the safe, compliant, and reliable execution of regenerative medicine manufacturing operations. This group directly supports SMPA’s mission by enabling facility start‑up, sustaining routine production, and maintaining operational readiness to deliver high‑quality clinical and commercial products.

Senior Manufacturing Associates serve as subject-matter experts on the manufacturing floor, executing and troubleshooting GMP processes, supporting process validation, and leading documentation activities, including batch records and SOP development. Through strong collaboration with Quality, Engineering, Supply Chain, and other cross‑functional partners, the group helps ensure inspection readiness, continuous improvement, and uninterrupted manufacturing operations aligned with SMPA quality and compliance standards.

Essential Functions Required for Job

Execute critical cGMP manufacturing operations in support of SMPA regenerative medicine production, including aseptic processing, material preparation, equipment operation, and in‑process activities in a controlled cleanroom environment.

Serve as a manufacturing subject matter expert (SME) by independently executing, troubleshooting, and coaching others on GMP manufacturing processes while ensuring adherence to approved procedures and regulatory expectations.

Support facility start‑up, process validation, and ongoing production readiness activities by performing process runs, providing real‑time feedback, and identifying opportunities for process robustness and efficiency improvements.

Author, review, redline, and manage manufacturing documentation , including Standard Operating Procedures (SOPs), batch records, forms, and labels, ensuring accuracy, completeness, and data integrity in compliance with cGMP requirements.

Own and support minor deviations, quality events, CAPAs, and change controls related to manufacturing operations, including root cause analysis and implementation of corrective actions in collaboration with Quality and Operations leadership.

• •Actively participate in continuous improvement initiatives such as 5S, waste walkthroughs, Kaizen events, and Lean or operational excellence activities to enhance safety, compliance, and manufacturing performance .
• •Maintain a high standard of safety and compliance, following OSHA, environmental health and safety, and SMPA site‑specific procedures while proactively identifying and escalating potential risks or compliance concerns .

Knowledge, Skills and Abilities (general & technical):

Demonstrated knowledge of cGMP manufacturing principles, aseptic processing, and cleanroom operations within a regulated pharmaceutical or cell and gene therapy environment.

Working to advanced knowledge of manufacturing equipment, materials, and processes, with the ability to independently execute and troubleshoot critical processing steps.

Strong 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 and continuous improvement.

Familiarity with process validation, facility start‑up activities, and inspection readiness expectations in a multi‑product manufacturing facility.

Strong problem‑solving and troubleshooting skills, with the ability to assess manufacturing issues, identify root causes, and communicate risks or solutions effectively to cross‑functional partners.

Ability to train, coach, and mentor Manufacturing Associates by providing technical guidance and reinforcing GMP expectations on the manufacturing floor.

Effective written and verbal communication skills, particularly for documenting manufacturing activities, authoring or revising SOPs, and collaborating with Quality, Engineering, and Operations teams.

Education & Experience Requirements:

A minimum of 3+ years of experience in a cGMP manufacturing environment along with a degree in science or a technical related discipline OR a minimum of 5+ years of cGMP manufacturing experience with a high school diploma is required.

Prior experience supporting new facility start-up and validation preferred.

Experience in aseptic operations required.

Scientific and or engineering knowledge attained through a degree or certificate program is preferred but not required.

Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.

Background in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations is strongly desired

Experience with batch record execution, including good documentation practices.

Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.

Individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds.

Travel Requirements:

Employees based in North Carolina onsite may need to travel up to 10% of the time as required. (Managers can modify this travel requirement to suit the particular role or business needs.)

Mental/Physical Requirements:

Lifting and Carrying: Ability to lift and carry materials, including heavy items, as part of daily operations.

Standing and Walking: Prolonged periods of standing and walking

Manual Dexterity: Handling and operating equipment and tools.

Climbing and Reaching: Ability to climb ladders or steps and reach for items stored at various heights.

Environmental Conditions: Working in varying temperatures and handling materials in different environmental conditions.

People Management

This is an individual contributor role and does not have direct reports or formal people‑management responsibilities.

Travel Requirements:

Employees based onsite may need to travel domestically and/or internationally up to 10-25% of the time as required. Additional travel may be required for Management roles.

Mental/Physical Requirements:

• •Lifting and Carrying: Ability to lift and carry materials, including heavy items, as part of daily operations.
• •Standing and Walking: Prolonged periods of standing and walking
• •Manual Dexterity: Handling and operating equipment and tools.
• •Climbing and Reaching: Ability to climb ladders or steps and reach for items stored at various heights.
• •Environmental Conditions: Working in varying temperatures and handling materials in different environmental conditions.

The base salary range for this role is

$70,900.00 - $88,600.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes up to 120 hours of vacation per year, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter and access to our service recognition program. Total compensation, including base salar