Quality Assurance Regulatory & CMC Manager

University of Pennsylvania•Philadelphia, PA

About The Position

The Manager of the Regulatory and Cell Manufacturing and Controls (CMC) unit plays a critical role in the regulatory affairs and quality assurance efforts of the Center for Cellular Immunotherapies (CCI). This role will ensure cGMP quality and compliance to release of investigational cell and gene therapy products for human administration manufactured within the Clinical Cell and Vaccine Production Facility (CVPF) at Penn for multiple clinical trials. These trials are early phase I/II first-in-human clinical development to treat subjects with relapsed/refractory cancer, HIV, and other serious diseases under clinical investigation. The Manager of the Regulatory and CMC unit closely coordinates with CCI Science Operations and the UPenn Office of Clinical Research (OCR) to create and manage the CMC strategy and regulatory compliance for IND applications, including supporting INDs, change controls, clinical product manufacturing data:, and annual reporting to regulatory bodies, and any FDA requests for information. The Manager of the Regulatory and CMC unit is a supervisory role and will direct a team of 3-4 quality assurance leads and associates to assure highly effective, team-oriented contributors to CVPF's success, and support effective and efficient continuous quality assurance. Providing quality and regulatory guidance as needed. Working in a highly cross-functional environment under tight deadlines with impact on patients and clinical teams, and with external collaborators/ contacts at biotech companies for providing quality and regulatory support in developing new INDs, clinical protocols, validation plans, and manufacturing products related activities.

Requirements

Bachelor's degree in Biology or related science and at least 5-7 years of experience working in an FDA/GMP regulated industry, or similar or equivalent combination of education and experience required.
Must have working experience in a cGMP facility, as well as sound quality and regulatory principles consistent with ‘best practices’.
Established knowledge of manufacture and required testing assays of gene therapy products.
Established knowledge of aseptic processing, regulatory and industry guidelines and requirement.
Experience in managing deviations and leading investigations are required
Project and time management skills are required.
Must be able to collaborate across the organization to manage a fast-paced environment with time sensitive deadlines and competing priorities for delivering exceptional service impacting patients is required.
Strong analytical and critical thinking skills are required
Detail oriented an working knowledge of GXPs (GDP, cGMP, GLP) are required
Excellent verbal and written communication skills and interpersonal skills are required.
Collaborate with other business units or departments in support of continuous improvement initiatives
Excellent organizational record keeping and planning skills are required.
Must be able to establish objectives and schedule tasks and resources efficiently
Flexibility to work weekends is required.
Position contingent upon funding.

Nice To Haves

Master's degree strongly preferred.
Diverse quality operations experience across functions in cGMP.

Responsibilities

Final Review and Disposition (Release/ Reject) of final infusible products for investigational cell and gene therapy products manufactured for first-in-human clinical development at CVPF facility.
Quality expert supporting the organization by establishing quality operational processes, quality systems, driving growth, and ensuring quality across cell therapy manufacturing operations.
Provides leadership, strategic thinking, and results focus mindset to reliably meet and/or exceed the site’s performance targets and client demands while achieving high levels of quality
Define and manage CMC strategy for INDs with CCI Research Operations and UPenn Office of Clinical Research (OCR).
Assist in preparation and review of IND annual reports including change controls, product manufacturing date , labeling reporting to regulatory bodies
Represent CVPF regulatory CMC function to external groups both within UPenn and regulatory and accredited agencies. FDA inquiry responses and IND applications.
Assist in clinical trial from development and study start-up activities and ensure regulatory compliance; and external audits from regulatory authorities, collaborators.
Direct and oversee all aspects of QA manufacturing operations within the organization, including but not limited to batch record review, QA support at the facility, critical materials release, deviation investigations, CAPAs, and collaborator quality support, SOPs. WIs, and guidance.
Approve new master batch records, SOPs, WIs, Validation Protocol, Scientific Information Report, Deviations, Out Of Specification Reports, Planned Product Deviation, labels for the manufacturing and testing of cell and gene therapy products, and relevant associated
Interact with the quality team and internal stakeholders to support the development, manufacturing, manufacturing, packaging and release of manufacturing products as needed
Work directly with external collaborators / contract biotech companies for providing quality and regulatory support in developing new INDs, clinical protocols, validation plans, and manufacturing products related activities
Perform other related duties as required

Benefits

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.
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.
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.
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.
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.
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.
Penn provides an array of resources to help you advance yourself personally and professionally.
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.
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 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 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.
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.