About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics , Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com .
Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com .
Overview
Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on TIL. The company’s lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has a commercially approved product along with multiple ongoing clinical trials in various phases for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company is currently developing its commercial manufacturing capacity to support development and launch of these assets.
Essential Functions and Responsibilities
Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
Lead teams investigating minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
Own and manage change controls associated with manufacturing areas and equipment.
Participate in technology transfer, conference calls and sharing of technical information.
Coordination of front-end document requests with supporting departments.
Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
Attends the weekly management meeting to discuss timelines and weekly priorities.
Contribute to projects to ensure timely initiation and completion of work.
May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.
Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Ensure raw data records are…