Director of Analytical Development

Location
Pennsylvania, United States
Posted
23 Jun 2020
End of advertisement period
23 Aug 2020
Ref
JR00003588
Contract Type
Permanent
Hours
Full Time

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Job Profile Title

Director, Senior Research Support

Job Description Summary

The Director of Analytical Development will provide leadership for both internal and external efforts to develop and execute complex analytical methods for viral vector product release. Lead the technology transfer to facilitate method qualification and validation.

Job Description

Lead biological development and lead both internal and external efforts to develop and execute complex analytical methods at contract Research/Development Organizations (CRO’s) for viral vector product release including potency, safety and product quality. Lead the technology transfer and of complex analytical methods to CROs and partner with QC to facilitate method qualification and validation. Manage efforts to internalize or outsource analytical capabilities as a key strategic component to drive vector production and development strategy into action by either internalize or outsource analytical methods to support client’s clinical and commercial development. Manage and direct internal analytical development efforts to refine, qualify, and implement basic viral vector analytical characterization and/or QC in-process and lot release methods.

Partner with Manufacturing and Quality functions (internal manufacturing QA/QC, Qualified Persons, and CRO Quality Organizations) to ensure effective SME support of technology transfer activities and CROs. Direct Analytical Development on documentation of external analytical method development efforts in CMC regulatory activities. The director will provide leadership and represent Pharmaceutical Development at cross functional CMC teams and/or Program Core Teams. Provide strategic CMC leadership and represent pharmaceutical development at cross-functional program team and CMC strategy meetings.

This position is contingent on funding.

Qualifications:

Ph.D. or equivalent doctoral degree and 5 years of experience required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$32,000.00 - $204,000.00

Affirmative Action Statement 

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

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.

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