Supervisor, Quality Operations

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 seeking a Supervisor of Quality Operations who has operational experience in Quality clean room activities and can provide QA oversight for manufacturing activities at the iCTC. The successful candidate will also help onboard new team members and manage deviations, CAPAs, and change controls. This individual will be responsible for supporting day-to-day Quality Operations activities relating to support manufacturing and release of products manufactured at the iCTC. The individual will be collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability. Essential Functions and Responsibilities: - Supervision and Development direct reports, mentoring/coaching to motivate and mentor peers/staff to foster a culture of continuous improvement, quality, and excellence. - Perform real-time, on-the-floor support for escalations to ensure compliance with GMP and GDP quality initiatives. - Schedule and coordinate daily activities ensuring conformance to the daily schedule. - Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements. - Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations, and other observations) and escalate if not resolved as appropriate to management. - Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management. - Support release of drug product and materials during the shift - Issuance of lot numbers and supporting documentation as needed for the shift. - Initiate and participate in standard operating procedure (SOP) revisions to improve compliance. - Review of Quality System records for compliance. - 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. 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 aseptic manufacturing. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired. - Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals; 21 CFR 1271 is a plus - Excellent oral and written communication skills - Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner - Must be comfortable in a fast-paced environment and changing priorities - Experience with use of an electronic QMS, MasterControl Preferred Education, Skills, and Knowledge The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following: - Must not be color blind. - Must have 20/20 near vision in both eyes (can be corrected) Physical Demands and Activities Required: - Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. - Must be able to work in a cleanroom lab setting with biohazards / various chemicals. - Must meet requirements for and be able to wear a half-face respirator. - Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps. - Ability to crouch, bend, twist, reach, and perform activities with repetitive motions. - Must be able to lift and carry objects weighing up to 45 pounds. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Work Environment: This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #li-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected]. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.