RESEARCH SPECIALIST C/D ASSAY DEVELOPMENT
Duties: The University of Pennsylvania (UPenn) Gene Therapy Program (GTP) is a state-of-the-art facility advancing gene therapy efforts through its own basic and translational research, providing vector-related materials and services through the UPenn Vector Core, and taking therapies into the clinic with scalable production and GLP/ GMP testing in the Process Development group.
GTP's Analytics Group is currently accepting applications for a Research Specialist C/D position in the Assay Development Group Group. The candidate will execute various characterization and lot release assays to assess the potency of viral-based vectors produced in the Gene Therapy Program in support of manufacturing as well as IND-enabling, Pharmacology/Toxicology and Clinical studies. The duties include design of potency assays, report writing, training of QC personnel and thorough documentation for all activities. Must be detail-oriented, organized, technically competent and be able to perform hands-on work in the laboratory.
The Research Specialist C would be responsible for basic research projects, performing assay validation and the Research Specialist D is responsible for multiple complex research projects and will design the validations studies to progress assay development.
The Research Specialist C/D will participate in writing of the SOP and BRF documents and will present data internally. The Research Specialist D will be responsible for training QC personnel and will present data with project sponsors, as well as internally.
For the Research Specialist C requires 3-5+ years relevant laboratory experience is required; for the Research Specialist 6+ years relevant laboratory experience is required.
Qualifications: Experience with cell culture and assay development is required.
Previous analytic assay development in one or more aspects such as ELISA, enzymatic, in-cell westerns, and/or high content imaging technologies is preferred but not required.
Experience with GraphPad Prism and/or JMP is preferred but not required.
Previous development of SOP and BRF is a plus but is not required.
Must be self-motivated and highly effective in a team-based environment.
Strong oral and written communication skills are required
Reference Number: 40-25372
Salary Grade: 026/027
Employment Type: Exempt
Org: DM-Gene Therapy Program
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