Senior Director, Analytical Qualification & Technical Transfer (Gene Therapy Program)
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Posted Job Title
Senior Director, Analytical Qualification & Technical Transfer (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.
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.
Our Vector Operations group, comprised of Manufacturing Sciences and Technology (MS&T), Analytical Sciences and Technology (AS&T) and External Manufacturing (EM) teams, provides manufacturing and analytical support of basic, translational and clinical research. The MS&T team is composed of teams that conduct platform development, process development and optimization, vector manufacturing and process technical transfer. The AS&T team conducts analytical development and qualification, testing, and assay technical transfer. The AS&T organization includes a molecular team, biochemical team, bioassay team and physical/chemical team as well as a Quality Control (QC) team. The analytical development teams (molecular, biochemical, bioassay and physical/chemical teams) develop, quality and conduct testing (research or GxP). The QC team currently oversees QC operations team including scheduling, stability programs, sample management and out-sourced testing and will expand to include QC testing for assays internally tech transferred from the analytical development teams.
Due to the continued growth of the Gene Therapy Program , we are seeking a Senior Director of Assay Qualification and Technical Transfer. The role of the Senior Director will be to establish a new team to support analytical testing and technical transfer both within and external to the organization. As Senior Director, you will oversee the establishment of method qualification procedures and the authoring of standard operating procedures applicable across the analytics organization. You will oversee the establishment of training policies and procedures and work closely with analytical leaders and QA on implementation. You will also oversee the technical transfer of analytics from assay development to internal QC teams as well as from GTP to external partners and CDMOs. You will work closely with Regulatory and Reg CMC to incorporate regulatory feedback into the analytics organization.
You will be expected to demonstrate a thorough understanding GxP including good documentation practices (GDP), good laboratory practices (GLP) and good manufacturing practices (GMP) as well as an understanding of regulatory guidances and requirements.
You will work both independently and as part of a team to accomplish project goals within specified timelines, workplans and budgets. Successful candidates will have experience building a QC unit, managing staff and managing multiple projects simultaneously. Importantly, successful candidates will have a strong understanding of GxP and regulatory guidelines as well as excellent written and oral communication skills.
Job Location - City, State
- BS or higher degree (MSc or PhD preferred) in molecular biology, biochemistry, chemistry or related disciplines with 7-10 years of experience required in the biopharmaceutical industry or similar
- Must have a thorough understanding of GxP and regulatory guidances for the manufacturing and testing of gene therapy products
- Must have expertise in assay qualification and technical transfer of assays for the release and characterization of biologics
- Must be highly motivated, have excellent organizational, communication (written and oral) and interpersonal skills
- Must be able to work independently and as part of a multi-disciplinary team
King of Prussia, PennsylvaniaDirector DDepartment / School
Perelman School of MedicinePay Range
$90,860.00 - $142,844.66
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. 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.University Benefits
Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care 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 pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
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 won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide 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 professionally.
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 Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn 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 tickets, and admission to theme parks.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
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/Senior-Director--Analytical-Qualification---Technical-Transfer--Gene-Therapy-Program-_JR00048929-2
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