Manufacturing Specialist I-2nd Shift

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Schedule Hours: Monday to Friday from 15:00-23:30 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 accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations. • Perform miscellaneous duties as assigned. Travel May require up to 10% travel, based on business need. Required Education, Skills, and Knowledge • Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience. •Minimum of 2 years of experience in biopharmaceutical based GMP manuf ... (truncated, view full listing at source)