Aseptic Manufacturing Technician 1

AboutIovance 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 Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). 

The Aseptic Manufacturing Technician , role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.

As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use.

This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.

As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.

Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1^st shift M-F); however, once the technician is trained, they will be assigned to a shift that include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday days or nights). May be required to work overtime.

Rotation Schedule:

Week 1: Shift B: Thursday to Saturday from 1800 to 0630

Week 2 Shift B: Wednesday to Saturday from 1800 to 0530

Essential Functions and Responsibilities:

• Develop a comprehensive understanding of and be able to proficiently execute Iovance’s GMP cell therapy manufacturing process(es).
• Complete training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Preps:
  • Provide operational support functions including:
    • Materials stocking and transfer.
    • Kit preparation.
    • Room readiness.
    • Equipment cleaning activities.
    • And inventory transactions using electronic inventory systems.
  • Hallway:
    • Material transfer.
    • Tumor receipt.
    • Chain of Information/Chain of Custody transactions.
    • Material incubation.
    • Feeder cell retrieval from liquid nitrogen (LN2) tanks.
    • Able to perform final product visual inspection.
    • Final product cryopreservation in controlled rate freezers.
  • BSCR:
    • Perform biosafety cabinet (BSC) runner duties as assigned.
    • Balance weight checks and operation.
    • Operation of liquid repeater pump.
    • Operation of tube sealers and welders.
    • Incubator-use for cell culture.
  • EM:
    • Perform in-suite environmental monitoring during the day of process
    • Perform document Environmental Monitoring duties using sample management electronic system.
  • Miscellaneous:
    • Able to train, pass and maintain gowning qualification.
    • Perform logbook review.
    • Attend the daily Tier 1 meeting and escalate issues/concerns at that forum to Area Management for further investigation.
    • Ability to work in a team environment and independently as required.
    • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
    • Must comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
    • Adherence to production schedule while maintaining internal production priorities.
    • Perform other duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree or equivalent experience.
• Minimum 0-1 year of experience in biopharmaceutical-based GMP manufacturing operations, including, aseptic technique, aseptic liquid transfers, use of welders and sealers, BSC aseptic operations and associated downstream processing is a plus.
• Must be able to read, write and understand English especially for Good Documentation Practices.
• Proficiency in Microsoft (Excel, Word, Outlook and Teams).
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fast-paced team-oriented environment and manage constant change.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request 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)
• Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.

Physical Demands and Activities Required:

• You 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-faced respirator for use of hazardous chemicals.
• 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 50 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 cleanroom setting, must be able to work with various chemical/biochemical exposures with appropriate PPE.
• Potential exposure to noise and equipment hazards and strong odors. 

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