Director, QC Testing (Gene Therapy Program)
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Posted Job Title
Director, QC Testing (Gene Therapy Program)
Job Profile Title
Job Description Summary
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. GTP is a complex R&D organization consisting
of research laboratories supported by multiple core functions which
provide internal capacity to perform gene transfer studies from
basic research through Phase 1 proof-of-concept human trials.
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.
Continuation of all GTP positions is contingent upon funding.
The GTP Vector Core is starting-up 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 GMP assays, oversee CMO's
in vector production and is expanding to conduct state-of-the art
Due to continued growth of our program, we are seeking to a add a
Director, QC Testing to oversee the institution of a GMP compliant
testing lab supporting the manufacturing and stability of advanced
gene therapy programs.
As the Director, QC Testing you will partner closely with
Manufacturing, Process Development, and Analytical Development to
support GTP programs to ensure we meet project timelines. You will
assemble, review, and generate reports as necessary to
support regulatory filings. Analytical method support will include,
but not limited to, continuous monitoring of method performance
(e.g., control charting, invalid rates, etc.), investigation
management, data integrity reviews and authoring and/or review of
relevant regulatory documents, Standard Operating Procedures and
Protocols (i.e., method qualification, implementation and
validation, specifications, batch analysis and reference
standards). You will work with Vector leadership to implement IT
solutions for compliance purposes and become a Subject Matter
Expert for QC/Analytical. You will need a team of scientists with
diverse responsibilities to support QC Operations.
Qualified candidates will have a strong background in biologics
analytics and quality control testing and experience working under
GLP or GMP standards. Experience with supporting Gene therapy
programs would be highly desirable.
● Master's Degree in Biochemistry, Analytical Chemistry, Molecular
Biology, Pharmaceutical Sciences or other relevant discipline and 5
to 7 years of experience or equivalent combination of education and
experience required. PhD preferred.
● Ability to comprehend technical information related to analytical
methods, processes, and regulatory expectations.
● Proven leadership, organizational and management skills to
coordinate cross functional decision making with executive
● Understanding and familiarity with FDA, EMA, MHRA, ICH and other
international regulatory requirements, guidelines, and
recommendations for quality system implementation.
● Understanding and experience with oversight of the pharmaceutical
quality system including good manufacturing, laboratory, and data
● Experience with using or implementing GMP compliant laboratory
● Experience validating methods and monitoring commercial method
● Experience drafting protocols and technical reports and QC
policies and procedures required.
● Experience with statistical analysis of analytical data and
stability studies preferred.
● Cross-functional, hands-on experience at a small
Job Location - City, State
King of Prussia, Pennsylvania
Department / School
Perelman School of Medicine
$74,476.00 - $117,086.00
Salary offers are made based on the candidate's qualifications,
experience, skills, and education as they directly relate to the
requirements of the position, as well as internal and market
factors and grade profile.
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Consideration of the background check will be tailored to the
requirements of the job.
- Health, Life, and Flexible Spending Accounts: Penn
offers comprehensive medical, prescription, behavioral health,
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family's health and welfare. You can also use flexible spending
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expenses with pre-tax dollars.
- Tuition: Take advantage of Penn's exceptional tuition
benefits. You, your spouse, and your dependent children can get
tuition assistance here at Penn. Your dependent children are also
eligible for tuition assistance at other institutions.
- Retirement: Penn offers generous retirement plans to
help you save for your future. Penn's Basic, Matching, and
Supplemental retirement plans allow you to save for retirement on a
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substantial amount of time away from work during the course of the
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- Long-Term Care Insurance: In partnership with Genworth
Financial, Penn offers faculty and staff (and your eligible family
members) long-term care insurance to help you cover some of the
costs of long-term care services received at home, in the community
or in a nursing facility. If you apply when you're newly hired, you
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variety of programs and resources to help you care for your health,
your family, and your work-life balance.
- Professional and Personal Development: Penn provides an
array of resources to help you advance yourself personally and
- University Resources: As a member of the Penn community,
you have access to a wide range of University resources as well as
cultural and recreational activities. Take advantage of the
University's libraries and athletic facilities, or visit our
arboretum and art galleries. There's always something going on at
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Relays at Franklin Field to name just a few examples. As a member
of the Penn community, you're right in the middle of the
excitement—and you and your family can enjoy many of these
activities for free.
- Discounts and Special Services: From arts and
entertainment to transportation and mortgages, you'll find great
deals for University faculty and staff. Not only do Penn arts and
cultural centers and museums offer free and discounted admission
and memberships to faculty and staff. You can also enjoy
substantial savings on other goods and services such as new cars
from Ford and General Motors, cellular phone service plans, movie
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- Flexible Work Hours: Flexible work options offer
creative approaches for completing work while promoting balance
between work and personal commitments. These approaches involve use
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- Penn Home Ownership Services: Penn offers a forgivable
loan for eligible employees interested in buying a home or
currently residing in West Philadelphia, which can be used for
closing costs or home improvements.
- Adoption Assistance: Penn will reimburse eligible
employees on qualified expenses in connection with the legal
adoption of an eligible child, such as travel or court fees, for up
to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Discovery-Labs---Building-27A/Director--QC-Testing--Gene-Therapy-Program-_JR00064796-1