Cell Culturing Specialist

DUTIES AND RESPONSIBILITIES:

• Perform all tasks associated with the manufacture of commercial product following batch records and SOPs
• Work as part of a small team to execute GMP runs in close collaboration with Product Sciences 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

REQUIREMENTS:

• Requires 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 commercial manufacturing
• Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment including Wave bioreactors
• 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
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Ability to work off-shift and long hours as required