Job Description
Job Description
Frederick, MD
Contract Duration : 6-18 months
Rate : Negotiable
Responsibilities :
- Excellent employment opportunity for a Cell Therapy Specialist I in the Frederick, MD area.
- 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.
Experience :
- 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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