Lead Downstream vector production, process optimization & development, and technology transfer in support of pre-clinical & IND-enabling research, early to late phase global clinical trials, and commercialization. Qualifying candidates will have a Master's Degree and 7 to 10 years of relevant industry experience.
Perform a wide range of moderate to complex high-throughput Next-Generation Sequencing (NGS) techniques, including DNA extraction, quantification, fragmentation, quality assessment, PCR, qPCR, Illumina and Oxford Nanopore sequencing. Qualifying candidates will have BS degree and 2-3 years of relevant laboratory experience.
Perform audits of translational research labs against written lab protocols and Standard Operating Procedures (SOP); reviewing SOP’s and updating formatting to comply with our standards; perform validation, batch record, and final written report reviews; perform facility audits as well as pre-audit inspections. Qualifying candidates will have a BS degree and 5-7 years of relevant experience.
Support the development of regulatory documents necessary for the submission of Investigational New Drug (IND) applications. Qualifying candidates will posses a Master's degree and 3 to 5 years of medical/regulatory writing experience. Experience with writing IND applications and eCTD format strongly preferred.
Be involved in planning, conducting and analyzing experiments aimed at development of new gene therapy methods & applications. Qualifying candidates will have a BS degree and 1 to 3 years of experience in research.
Lead and conduct bench research to develop gene therapy treatments for various therapeutic areas. Qualifying candidates will posses a Ph. D. and 5 or more years of relevant research experience.
Lead a GXP Quality Assurance Unit (QAU), including GLP/GMP’s within GTP, supporting the development, manufacture, and testing of viral vectors for clinical trials. Qualifying candidates will have a Master's Degree in life science and 7 to 10 years of biopharmaceutical QAU experience.
Oversee, monitor, and support colony management activities for all rodent breeding colonies maintained by GTP. Qualifying candidates will have a Master's Degree in life science and 3 to 5 years of relevant experience with colony management.
Maintaining the physical and psychological health of laboratory animals utilized in gene therapy research; compliance with regulations governing humane and ethical treatment and use of laboratory animals; animal model development; ensuring quality animal supply for studies. Qualifying candidates will have a DVM/VMD degree from an AVMA-accredited veterinary school and a minimum of 1 year of experience in Laboratory Animal Medicine required.
Lead all aspects of study design, development, testing, interpretation, troubleshooting, and innovation of Next Generation Sequencing efforts within GTP. Qualifying candidates will have a Ph. D. and 5 years of experience in molecular biology and bioinformatics.