Bioassay Developer

Screen reader users may encounter difficulty with this site. For assistance with applying, please contact . If you have questions while submitting an application, please review these frequently asked questions . Current Employees and Students: If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following:

• Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required.
• Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.

Job Title:Bioassay DeveloperDepartment:James | Cell Therapy Laboratory

Scope of Position

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 (e.g., Nationwide Children’s 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, which involves developing and validating new processes or QC testing assays, 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 focus of the Senior BioAssay Developer is to perform translational development of these new manufacturing processes and QC testing assays. This will be done in the CTL’s Process Development Laboratory, which is regularly staffed five days a week (Monday through Friday) with weekend hours as needed.

Position Summary

The CTL Senior 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.

Minimum Qualifications

• A Bachelor’s degree in an appropriate biological / health science is required; Master’s 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.

Additional Information:Location:Wiseman Hall (0157)Position Type:RegularScheduled Hours:40 Shift: First Shift Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions .

The Ohio State University is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability, ethnicity, gender identity or expression, genetic information, HIV/AIDS status, military status, national origin, race, religion, sex, gender, sexual orientation, pregnancy, protected veteran status, or any other basis under the law.

Applicants are encouraged to complete and submit the Equal Employment Identification form.