Bioassay Developer

The Cell Therapy Laboratory (CTL) performs manufacturing, testing and storage of therapeutic cellular therapy products for administration to patients of the James Cancer Hospital, Wexner Medical Center and other outside hospitals under contract (, Nationwide Childrens Hospital). The CTL is regulated by the Food and Drug Administration (FDA) as both a registered manufacturer of human cells, tissues, and tissue-based products (HCT/Ps) and under current Good Manufacturing Practices (cGMP) for investigational new drug (IND) applications. The CTL is heavily involved in clinical research, performing translational development of new processes or QC testing methods, validating these new methods, preparing IND submissions, manufacturing investigational cell therapy products, maintaining blinding and performing randomization of patients if needed, and maintaining investigational drug accountability and other study records. The CTL is available 24/7 as needed to meet the needs of the clinical programs it serves.

The CTL Bioassay Developer develops, evaluates, and transfers complex laboratory tests and cell processing methodologies from translational research into the clinical laboratory providing intellectual and scientific expertise to support and conduct complex clinical research in cellular therapy. Process development often entails the acquisition, modification and/or use of new technology and requires more cell biology, immunology and molecular experience and expertise than routine cell processing. Primary responsibilities are design, development and validation of new manufacturing and QC testing processes in an FDA-regulated environment ensuring compliance with current Good Manufacturing Practices (cGMPs). Primary technical job duties are process and assay development and/or refinement, preparation of validation protocols, troubleshooting process failures, maintenance of development and clinical data and assisting in the preparation and publication of pre-clinical and clinical research studies with an emphasis on novel cell therapy processing methods. Additional administrative duties are technical procedure writing and development of training materials for technologists, residents and fellows, keeping current with scientific literature that pertains to processing and testing performed in the laboratory and guiding policy for the implementation of new processes. This individual primarily works first shift, Monday Friday, but evenings and weekends may occasionally be required at times to accomplish job duties.

Minimum Qualifications

• A Bachelors degree in an appropriate biological / health science is required; Masters degree or an equivalent combination of education and experience is preferred.
• Extensive experience in a biological / health science or research, a variety of cell biology, immunology and molecular techniques is heavily preferred.
• Experience in a progressively responsible administrative capacity is preferred.
• Experience in cGMP manufacturing, grant or article preparation, SOP writing is desired.
• Must work independently and be self-directed.
• Attention to detail, and excellent written and verbal communication skills are required.