Cell Therapy Specialist
11 hours ago
Fladger Assoc. Inc. is seeking a highly skilled Cell Therapy Specialist I to join our team in Frederick, MD.
Job SummaryWe are looking for a detail-oriented and organized individual to perform tasks associated with the manufacture of clinical and commercial product following batch records and SOPs. The successful candidate will work closely with Process Development and Quality to execute GMP runs and assist in the development of standard operating procedures, batch records, deviations, and change controls.
Responsibilities- Perform all tasks associated with the manufacture of clinical and commercial product following batch records and SOPs.
- Work as part of a team to execute GMP runs in close collaboration with Process Development and Quality.
- Assist in the development of standard operating procedures, batch records, deviations, and change controls.
- Successfully troubleshoot processing and equipment issues.
- Other duties as assigned.
- Associates Degrees or High School Diploma with industry experience, Bachelor's Degree and/or advanced Degree or 3 or more years of cGMP experience in a Manufacturing Pharmaceutical/Biotechnology environment.
- Cell culture processing experience.
- Previous experience with cell therapy products is a plus.
- Demonstrated knowledge of Pharmaceutical Manufacturing of Biotechnology products, aseptic processing, cell culture products.
- Strict adherence to SOPs and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing.
- Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment.
- Experience with handling and propagation of human primary cells, including T cells.
- Excellent skill in Microsoft word, Excel and data analysis.
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
- Ability to work off-shift and extra hours as required.
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