Aseptic Processing Technician I [Contract to Hire]

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 Aseptic Processing Technician I role is crucial for the iPBMC used in the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Aseptic Processing Technician I will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, it is strongly desired that the candidate has a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work on weekends and holidays.

Shift: Tuesday to Friday from 0700 to 1730.

Essential Functions and Responsibilities
• Develop a comprehensive understanding of and be able to execute Iovance’s GMP proficiently.
• Complete training sessions and ensure training documentation is maintained.
• Completes recording of data to comply with regulatory requirements.
• Perform document review, including executed Batch Records and Logbooks.
• Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Identify errors and report them promptly to area management. Participate in root cause analysis and implement corrective actions.
• Ability to work in a team environment and independently as required.
• Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Adheres 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 - Up to 5% of travel

Required Education, Skills, and Knowledge

• Minimum B.S./B.A. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• Minimum 0-1 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Must be able to deal with ambiguity – ready to change gears and plans quickly and manage constant change.
• Able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
• Able to accurately perform basic math, including fractions, decimals, and percentages.
• Able to work effectively with team members and show initiative to assist others on the team.
• Able to work successfully in a fast-paced, team-oriented environment.

Preferred Qualifications

• Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA.

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)
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.

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.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to lift 45 lbs.

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.

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