Supervisor, Aseptic Manufacturing

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

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.

 

Rotation Schedule:

Week 1: Shift A: Sunday to Wednesday from 0700 to 1830

Week 2 Shift A: Sunday to Tuesday from 0700 to 1930

 

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 communication skills and actively contributes to training, report generation, and documentation (batch records, deviations, etc.). Strong technical writing ability is required.
• Experience leading “development” initiatives, i.e., training, coaching, and learning initiatives.
• Ability to mentor and provide best practices to other team members. 
• Ability to build relationships quickly and credibly. Provide consistent, excellent support to the 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. 
• Proactive, results-oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
• Ability to work successfully in a fast-paced, team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Remains current regarding Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to address compliance issues fully.

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 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 motions.
• 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 manage 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.

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