RESOURCE TECHNOLOGIST A
Duties: This position will support cellular manufacturing activities to produce investigational products for early phase I/III cell and gene therapy clinical trials to treat patients diagnosed with cancer and/or infectious diseases supported by the Clinical Cell and Vaccine Production Facility (CVPF) and Center for Advanced Cellular Therapies (CACT) at the University of Pennsylvania. Primary responsibilities may include preparation of clinical reagents and supplies for manufacturing, conducting cell and tissue processing activities including isolation, ex vivo culture maintenance, and dose formulation using sterile technique and universal precautions. Additional duties include preparing manufacturing suite for production runs, gathering all pertinent standard operating procedures (SOPs) and forms for product batch records, clinical data entry and verification, maintaining inventory logs for critical reagents, and preparation of requests and reports for time sensitive submissions. This position will support senior manufacturing leads, and may involve additional responsibilities that may include assisting in process improvement projects, validation plans, and large scale process development activities to initiate first in human clinical studies. This position will involve routine interaction with additional manufacturing technicians, quality control scientists, quality assurance personnel, and additional support staff as necessary. This position is an Essential University employee and is required to report to work in times of inclement weather and University closure. Additional responsibilities may apply.
Position is contingent on continued funding.
Qualifications: Bachelor's degree in Biology or related science and 1-2 years of experience in science or equivalent combination of education and work experience is required. Knowledge of medical terminology and intellectual capacity to use judgement and critical thinking skills to ensure that the data are accurate, logical, and consistent with institutional and regulatory reporting requirements are essential. Experience with general laboratory techniques, mammalian tissue culture and stringent aseptic technique are required. Good verbal and written communication skills and understanding of scientific literature is required. Ability to work in cross-functional teams is essential. Experience with regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations part 211 and a working knowledge of Good Manufacturing Practices (GMPs) are highly preferred but not required. Experience working with clinical trials, and in particular, cellular manufacturing is preferred. Exceptional organizational skills, strong attention to detail, and demonstrated expertise in tissue culture are required. Efficient time management and ability to multi-task to complete activities for several different clinical trial studies at a given time are essential. Flexibility to work off peak hours, including weekend assignments as necessary is required.
Reference Number: 40-25037
Salary Grade: 024
Employment Type: Exempt
Org: PA-Pathology Bioresource
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research