Job description

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.
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.

The Vector Core is on the hunt for a Senior Project Manager of Vector Operations (SPMVO) to manage the critical path of vector activities in GTP from research and development to clinical manufacturing.

As a SPMVO, you will lead the facilitation of preclinical and GMP vector operations into successful large-scale clinical production, as well as ensure a consistent supply of vector services for GTP research, phase I studies and commercial products with limited direction. You will guide project team activities to meet GTP's vector core objectives and drive team accountability for deliverables, ensuring projects meet defined milestones. You will lead technology transfers with external contract manufacturing organizations (CMOs) which are responsible for the establishment and continuance of scalable clinical manufacturing operations. You may need to travel and be on-site at partnering CMO's to effectively manage this activities. You will coordinate and facilitate Launch Team Meetings where you will document outcomes, actions, and risks. You will prepare and manage budgets, project timelines, project scope documents and all other project documentation. You will ensure that all aspects of the chemistry, manufacturing, and controls (CMC) are represented in work plans, timelines, and budgets associated with clinical (GMP) vector manufacturing. You will be the liaison to our external sponsor project leaders, delivering transparent, timely and concise verbal and written communication during regular status updates and technical reports.

You will work with internal teams and external CMO's to prepare technical reports to submit to external project sponsors. You will review these submissions to ensure the integrity of the data and partner with Study Director to resolve technical/data issues with these submissions. Proactively identify and escalate risks and issues to relevant stakeholders; lead development and delivery of tactical and achievable mitigation and contingency planning. You will continue to drive manufacturing activities through phase I & phase II clinical trials and lead technology transfer efforts when projects are ready to be turned back over to external sponsors.

Qualifications: Master's degree in Life Science or Engineering and 5 to 7 years of applicable experience, preferably in engineering or manufacturing project management, or an equivalent combination of education, are required.
Strongly prefer Engineering experience
PM certification is desired.
Experience leading manufacturing projects, managing aspects chemistry, manufacturing, and controls (CMC) is required
Ability to interact professionally with key internal investigators, as well as external academic, for-profit, and non-profit organizations.
Ability to work with all levels within the organization from senior management to technicians.
Ability to work independently and to perform well under pressure and embrace dynamic environment. Strong organizational and time management skills. Excellent oral & written communication skills with exceptional attention to detail.
Strong computer/technology skills including MS Excel, PowerPoint, and MS Project (or other similar Project Management tools).

Reference Number: 40-27468

Salary Grade: 029

Employment Type: Exempt

Org: DM-Gene Therapy Program

Special Requirements:

Job Family: I-Technical/Professional Research




Diversity Profile: University



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Job No:
Posted: 12/4/2017
Application Due: 5/12/2018
Work Type: