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