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…