DIRECTOR, GLP QC & ASSAY DEVELOPMENT
Duties: GTP is a complex R&D organization consisting of research laboratories supported by multiple core functions which provide internal capacity to perform gene transfer studies from basic research through phase 1 proof-of-concept human trials. The R&D enterprise has at its core a translational infrastructure that includes: technology discovery, specialized immunology and quality control assays operating under GLP, research vector production, GMP process comparable vector production and a large non-clinical program for animal testing under GLP. GTP collaborates with the Department of Medicine in the organization and conduct of phase I trials. These programs involve multiple federal, nonprofit and commercial partners.
Vector technology lies at the heart of GTP due to the contributions of the Wilson Lab. GTP has a long track record of success in developing vector technology and manufacturing and distributing vectors for research purposes. Once successful in the research environment, the vectors must be transferred to the clinic which requires expertise both in terms of vector manufacturing and characterization.
The Director of GLP QC and AD (DA) oversees GLP quality control testing and assay development in support of pre-clinical research, GLP animal studies, and early-late phase clinical development. The DA will have experience in developing and qualifying assays for the characterization of drug products. The DA will oversee separate groups conducting assays to assess the quality of vectors for use in IND-enabling studies as well as for use in human clinical vectors and developing assays for research, translational and clinical studies. The DA will report directly to the Senior Director of Analytics of the Gene Therapy Program.
Qualifications: - Master's Degree and 5 to 7 years of applicable experience preferably in the pharmaceutical industry, or an equivalent combination of education and experience, required.
- Ph. D. strongly preferred
-Minimum of 3 years of supervisory experience
- Extensive knowledge of assay development and qualification
- Experience in interactions with outside vendor (CRO's)
- Experience in interactions with regulatory agencies
- Understanding of GLP (preferrably GxP) guidelines
- Ability to provide assay expertise to product development
- Self-starter but also a strong desire to contribute and work collaboratively to achieve goals
- Success in roles requiring execution of multiple tasks while responding to multiple priorities
- highly functioning, detail-oriented, and analytical candidate
- Excellent oral/written communication skills required
Reference Number: 40-29584
Salary Grade: 029
Employment Type: Exempt
Org: DM-Gene Therapy Program
Job Family: B-Executive/Managerial Administration