"Quality Assurance Regulatory & CMC Manager"

Job Description Summary

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.

Job 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

Qualifications

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. Master's degree strongly preferred.

• Diverse quality operations experience across functions in cGMP. 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.

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$89,500.00 - $109,500.00 Annual Rate

University Benefits