ASSOC DIR, EXTERNAL MANUFACTRNG
University of Pennsylvania

Duties: The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the 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.

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 novel vector technologies, manufacturing platforms and analytics as well as distributing vectors for research purposes. Once successful in the research environment, the vectors must be transferred to the clinic which requires expertise both regarding vector manufacturing and characterization. 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, produces vectors in support of IND-enabling research, develops and conducts GLP assays, oversees CMO's in vector production and is expanding to perform state-of-the-art process development.

Due to significant growth, the Vector Core is looking for a new Associate Director, External Manufacturing (ADEM) to lead the development of external Chemistry Manufacturing Control (CMC) project plans for GTP programs.

As the ADEM, you will develop the external manufacturing plans and lead the interaction of the CMC cross-functional projects among GTP personnel, and between GTP and the Contract Manufacturing Organizations (CMOs). You will travel to CMOs during campaign launches and throughout the campaign as needed to monitor and manage CMC process transfer, supply chain, budgets, and ensure project milestones and timelines are being met from early to late stage production at CMO. You will create and maintain comprehensive risk management plans for product production to minimize the impact of obstacles to overall campaign goals.

Top candidates in this role will have a strong background in biopharmaceutical manufacturing, process and analytical development, and process transfer as well as have experience in planning and managing CMC aspects of biopharmaceutical development.

Qualifications: * The minimum of a Master's degree in Chemical or Biomedical Engineering or similar field with 5-7 years of experience with processes to make biologics, viral vectors, or vaccines or an equivalent combination of education and experience required.
* Experience with planning and managing CMC aspects of biopharmaceutical development required
* Experience in process development (including design of experiments, DOE) and process transfer, focused on biologics, viral vectors, or vaccines required
* Experience in CMO search, selection and management strongly preferred
* Experience in person in plant (PIP) for production of biopharmaceutical products strongly preferred
* Must have the ability to travel (domestic) 10 - 20% of the time, particularly when production campaigns are being done
* Must have a demonstrated ability to organize external resources to maximize quality and efficiency; maintain an overview of the entire process when planning a project, setting both short and long-term goals
* Must work efficiently aligning actions to project targets, milestones, and priorities
* Must have excellent communication skills, with the ability to provide clear, audience focused descriptions of CMC tasks and issues, and proposed solutions to schedule challenges, all done in an open and honest manner
* Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal (and sometimes external) stakeholders.
* Familiar with current issues and Regulatory requirements related to manufacturing using single use equipment for drug substance and drug product production
* Familiar with trends and developments in the gene therapy field and able to translate those developments into specific business advantages and risks related to production.
* Proficiency with Microsoft Office suite (e.g. Word, Excel, PowerPoint, Project, Outlook) and Visio and JMP or similar
* Valid driver's license.

Reference Number: 40-30247

Salary Grade: 029

Employment Type: Exempt

Org: DM-Gene Therapy Program

Special Requirements:

Job Family: B-Executive/Managerial Administration