DIRECTOR/SR DIRECTOR CLINICAL VECTOR SERVICES
Duties: Reporting to the Executive Director, Vector Operations (EDVO) of the Gene Therapy Program (GTP), the Director/Senior Director of Clinical Vector Services (D/SDCVS) oversees all aspects of the production of vector in support of IND-enabling studies and clinical trials. This translational step represents the critical path in the continuum of basic research to proof-of-concept in clinical trials.
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 assays operating under GLP, a Vector Core and Manufacturing unit that conducts GMP-based assays and oversees contract manufacturing organizations (CMOs) in vector production, and a large non-clinical program for animal testing under GLP, including nonhuman primate and mouse vivaria; GTP collaborates with the Department of Medicine in the organization and conduct of phase 1 trials. These programs involve multiple federal, nonprofit and commercial partners.
Vector technology lies at the heart of the GTP due to the contributions of the Wilson Lab. While most of the recent work has focused on AAV vectors, the Wilson Lab has also made important discoveries in adenovirus and retro/lentivirus vectors. The D/SDCVS is a position that was created in the context of a major re-organization of GTP in the area of vector technology and will oversee advanced vector manufacturing, process development and technological transfer. Specifically, the Director (DCVS) will be responsible for the manufacturing of vectors in a GMP process-comparable manner and will oversee an Associate Director of Clinical Vector Services as well as 4 - 6 Resource Technologist/Research Specialists. The Senior Director (SDCVS) will, in addition, be responsible for the development of scalable upstream and downstream processes suitable for GMP vector production in support of late phase clinical trials and commercialization and oversee a Director of Process Development as well as 2 - 4 staff. The Senior Director (SDCVS) will also be responsible for the transfer of manufacturing processes to contract manufacturing organizations (CMOs) and manage the production of clinical vector at CMOs. Finally, the Senior Director will participate in the establishment of GMP vector manufacturing capabilities at Penn. The preferred candidate will therefore have industry experience in overseeing manufacturing of biologics, developing manufacturing processes suitable for clinical translation and in managing production activities at CMOs.
Qualifications: * The minimum of a Bachelors degree and 7 to 10 years of experience or an equivalent combination of education and experience is required; PhD preferred
* Strong pharmaceutical experience
* Minimum of 5 years of supervisory experience
* Extensive knowledge of biologics manufacturing, including interpretation and implementation of FDA regulations, GLP and GMP, is required
* Experience in interactions with outside vendors, e.g., CROs and other vendors
* Ability to provide manufacturing expertise to product development overseeing multiple programs
* 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 who can think strategically
* Excellent oral/written communication skills required
Reference Number: 40-24760
Salary Grade: 030
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: B-Executive/Managerial Administration