University of Pennsylvania

Philadelphia, Pennsylvania

Duties: The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.

The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the 'go-to' organization for public and private partners, who want to participate in the gene therapy space. Currently we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.

Our Vector Core is a state-of-the-art facility which provides vector-related materials and services in support of basic and translational research worldwide, producing vectors in support of IND-enabling research, conduct GLP assays, oversee CMO's in vector production and is expanding to conduct state-of-the art process development.

Due to significant growth, the Vector Core is looking for a new Senior Director of Manufacturing Science & Technology (SD-MS&T) to lead cross functional teams responsible for pre-clinical & clinical 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.

Reporting to the Executive Director, Vector Operations (EDVO) of GTP, as the SD-MS&T, you will lead and drive current and future strategy as it pertains to manufacturing science and technology. You will oversee the activities of and develop/mentor a high-performing team in multiple functional areas, including pre-clinical vector production and cloning, upstream and downstream clinical vector manufacturing, process optimization & development, and tech transfer. You will use sound scientific and engineering criteria to design and develop manufacturing processes and oversee process optimization strategies to ensure successful execution of projects. Interface with external sponsors and CMO's to build strategies to support global initiatives, preparing presentations and other materials for external meetings, regulatory filings, publications, and grant applications. You will implement metrics to track and manage completion of objectives and projects. You will support regulatory interactions and contribute to the content of manufacturing-related sections of regulatory documents. Also, you will participate in the establishment of GMP vector manufacturing capabilities at Penn.

The preferred candidate will have industry experience in overseeing manufacturing of biologics, developing manufacturing processes suitable for clinical translation and in managing production activities at CMOs.

Qualifications: * A Master's Degree in Bioengineering, Biology, Biochemistry and 7-10+ years of industry experience in process development required
* Ph. D. strongly preferred
* Minimum of 5 years of supervisory experience required
* Extensive knowledge of biologics manufacturing, FDA regulations (GLP and GMP)
* Experience in interactions with outside vendors, e.g. CMOs, CROs
* You must have the ability to think strategically and to translate strategy into actions.
* 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: 40-30791

Salary Grade: 030

Employment Type: Exempt

Org: DM-Gene Therapy Program

Special Requirements:

Job Family: B-Executive/Managerial Administration

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