Supervisor, Aseptic Manufacturing - Night 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. Overview The Supervisor for Aseptic Manufacturing oversees the production process to ensure that all materials are produced safely and follow the company's standards. This position requires timely document review and ensuring all targets are met. In addition, the supervisor will be responsible for developing staff and implementing an effective "First-time right" program to meet Iovance's growing demands. The successful candidate will also help onboard new team members and manage deviations and CAPAs for the training and learning team. It is crucial that the supervisor has innovative technical knowledge and contributes significantly to the overall manufacturing operation. As a leadership team member for autologous cell therapy manufacturing operations, a background in cell culture and manufacturing in ISO class 5 cleanrooms is necessary. Essential Functions and Responsibilities • Supervision and Development direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff to foster a culture of continuous improvement and operational excellence. • Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule. • Develop a comprehensive understanding of the current production process, as this role is viewed as a subject matter expert within a specific area. Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility are required. • Provide oversight of the manufacturing process, ensuring technicians follow cGMP practices and utilize proper aseptic techniques. • Review batch documentation and logbooks for completeness and accuracy. • Ability to work under limited supervision and handle problems of a more complex nature. • Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of the operation. • Establish objectives and conduct performance reviews, monitor progress toward goals, and provide timely feedback to Management. • Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. • Ensure the department understands and complies with quality standards and requirements as documented. • Ensure efficient operations and compliance with cGMPs and safety regulations. • Work in a cleanroom with biohazards, human blood components, and chemicals • 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 - 10% Required Education, Skills, and Knowledge • Minimum B.S. in biology, biochemistry, bioengineering, related technical field, or equivalent industry and technical experience. • Minimum of 5 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired. • Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must. • Strong knowledge and experience of the end-to-end learning process, i.e., learning needs assessment, program design and delivery, and learning evaluation and training effectiveness assessment. • Demonstrates strong oral and written