Cell Therapy Manufacturing Scientist Position Available In Chester, Pennsylvania

Cell Therapy Manufacturing Scientist 4.4 4.4 out of 5 stars Malvern, PA 19355 A well-funded and rapidly expanding cell therapy company is seeking a passionate and detail-oriented Cell Therapy Scientist to join its manufacturing team. This role supports the production of high-quality cell therapy materials during process transfers, routine manufacturing, and continuous innovation efforts. You’ll play a key role in ensuring timely delivery of GMP-compliant product for clinical trials and future commercial use.

Key Responsibilities:

Perform aseptic mammalian cell culture within a Grade A cleanroom environment. Execute production batch records and work orders according to SOPs, protocols, and quality standards. Support all aspects of cell therapy manufacturing, including inventory tracking, material movement, maintaining production metrics, completing log sheets, and assisting with special projects. Participate in manufacturing batch record reviews to ensure compliance and completeness. Under supervision, initiate deviations and contribute to root cause investigations and CAPA implementation. Draft and revise documentation, including SOPs, WINs, and batch records. Prepare and batch media in accordance with production needs. Maintain cleanliness of manufacturing spaces and equipment to GMP standards. Identify opportunities for process optimization and drive continuous improvements. Strictly follow safety policies, quality systems, and GMP guidelines. Perform final drug product visual inspections to ensure integrity and quality.

Qualifications:

Bachelor’s degree in Pharmaceutical Sciences, Biology, Chemistry, or a related scientific field. Prior experience working in a cGMP environment performing mammalian cell culture is required. Experience working in a cleanroom setting is essential; candidates must be comfortable in a highly controlled and sterile environment.