Cell Therapy Specialist I Job at Fladger Assoc. Inc. in Frederick

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