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 Pennâ™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.
Posted Job Title
Director of Analytical Development
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.
Lead biological development and lead both internal and external efforts to develop and execute complex analytical methods at contract Research/Development Organizations (CROâ™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 clientâ™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.Â 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.
Ph.D. or equivalent doctoral degree and 5 years of experience required.
Job Location - City, State
Department / School
Perelman School of Medicine
$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.
Internal Number: JR00003588
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.