Manager, Manufacturing 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 In this postion, one provides guidance and oversite to the process and production as well as timely document review, ensuring material is made in a safe and compliant manner and meeting company targets. This individual is directly responsible for the teams whose goals are to produce products on the manufacturing floor. The Manufacturing Manager is also responsible for the development of staff, to accommodate Iovance's needs as a growing organization. Rotation Schedule: Week 1: Shift A: Sunday to Wednesday from 1800 to 0530 Week 2 Shift A: Sunday to Tuesday from 1800 to 0630 Essential Functions and Responsibilities - Oversees the Manufacturing Operations team to support startup and clinical production, as well as initial plan for commercial material in support of Iovance's strategic objectives. - Develop schedules for manufacturing that meet monthly and quarterly targets. Ensure resources are adequate to complete operations and fully optimized from an operational excellence perspective. - Lead critical level investigations as related to the manufacturing and initial validation steps. Approve deviations, non-conformances, and CAPAs as Partner with Quality to address these issues effectively and compliantly. - Identify, lead, and implement continuous improvement opportunities for process and production related items. Expert level in visual management, KPIs, huddle boards etc. Continuously seek and support new approaches, practices, and processes to improve the efficiency and effictivity of the operation. - Ensure batch-related documentation (batch records and SOPs) is closed in a timely manner to support batch Since it is a just-in-time manufacturing process, careful coordination and communication will be required between Operations, Quality Release and Supply Chain team. - Maintain robust training program to ensure timely, efficient, and effective training of individuals. A highly effective "First time right" program is required for autologous cell - Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per - Develop and provide monthly manufacturing metrics and "Health of the Operations" - Lead personnel actions to include recruiting, onboarding, performance management, training, promotions, transfers, etc. - Supervision and development of direct reports, mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence. - Establish objectives and conduct performance reviews, monitoring progress toward objectives 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 - Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business - Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA - Perform miscellaneous duties as assigned Travel - May require travel based on business needs Required Education, Skills, and Knowledge - Minimum S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience. - Demonstrated technical knowledge of aseptic processing in cleanroom environments a - Solid knowledge of FDA regulations and GMP - Solid knowledge of human error reduction strategies, right-first time execution, and just - Demonstrated project management Excellent oral and written communication skills. Strong technical writing ability. - Experience leading “development” initiatives, e., training, coaching, learning initiatives. - Ability to motivate and mentor peers and staff as well as foster a culture of continuous improvement and operational excellence. - Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing Self-motivated and willing to accept temporary responsibilities outside of initial job description. - Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. - Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change. - Ability to build relationships quickly and Provide consistent, excellent support to entire staff, with the ability to manage and influence large teams within the manufacturing environment (potentially 50+ employees) representing a variety of personalities and experience levels. Preferred Education, Skills, and Knowledge - Minimum 3+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing. - As this person will be the responsible for oversight of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required. Cell/gene therapy experience. - Minimum of 5-10 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream - Minimum of 3 years in a Lead/Leadership/Supervisory - Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA - Proactive, results oriented, self-starter with experience in a complex manufacturing 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 clean room attire and all Personal Protective Equipment (PPE),i.e. scrubs, gowning coverall, masks, gloves, etc. - 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. - Able to crouch, bend, twist, reach, and perform activities with repetitive motion - Must be able to lift and carry objects weighing 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 deadline Work Environment: - This position will work in both an office and a manufacturing lab - When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach. - Able to work in cleanroom with biohazards, human blood components, and chemicals - Potential exposure to noise and equipment hazards and strong odor #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]. 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