Job Title: Cell Processing Technologist
Location: Louisville, KY
This position is responsible for day-to-day operations related to the conduct of Clinical Phase I, II, and III trials in cell therapy. This includes Good Manufacturing Practices (GMP) production of a cell therapy product and research and development. The primary responsibilities of this role focus on cell processing; secondary responsibilities include clinical research and development and programmatic organization activities.
- Conduct aseptic cell processing to produce preclinical and clinical lots of the FCR001 product, following established Standard Operating Procedures (SOPs) and batch records and adhering to applicable regulations and standards
- Proficiently function within an ISO Class 7 and 8 clean room environment, ensuring personal safety and product safety
- Maintain consistent and accurate documentation, following Good Documentation Practices
- Perform cryopreservation of the cell therapy product using a controlled-rate freezer
- Proficiently operate and maintain equipment according to designed procedures. Equipment may include use of CliniMACs cell separator, controlled-rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, liquid nitrogen freezers, micropipets, refrigerators, ultra-cold freezers, tube sealers, dry shippers, and centrifuges
- Notify Management of any deviation that may occur during processing and complete all related documentation in a timely manner
- Participate in R&D and research related to production of the cell therapy product. Responsibilities may include sample preparation, sample shipping, and preparation of media or reagents
- Perform related duties as assigned
- Associate’s Degree in a related field of Science + 2 years relevant work experience
- Current Medical Technologist license or equivalent professional certification preferred
- Experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing facility preferred
- Ability to work effectively in a fast-paced environment and consistently meet deadlines
- Strong work ethic, methodical approach to new challenges
- Team-oriented interpersonal skills are essential
- Flexibility and dedication: Position will require “off-standard hours” and “on-call” hours related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime.
- Please note that the position requires a general occupational health screening performed by an approved occupational health unit to work with the cell therapy product in the cGMP cleanroom facility. These examinations are necessary to protect the cell therapy product during the manufacturing process. Applicants who intend to work with the open product shall not submit to a health screen until after an offer of employment has been made.
Apply: Please submit resume or CV and cover letter to firstname.lastname@example.org