Aseptic Manufacturing Technician I - Day Shift B [Contract to Hire]

About the role

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 I role is crucial for the autologous cell therapy manufacturing program, requiring a broad understanding of theories, techniques, and principles to support manufacturing processes.

Responsibilities

• Develop a comprehensive understanding of and 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).
• Provide operational support functions including:
  • Materials stocking and transfer.
  • Kit preparation.
  • Room readiness.
  • Equipment cleaning activities.
  • Inventory transactions using electronic inventory systems.
• Perform material transfer, tumor receipt, chain of information/custody transactions, material incubation, and feeder cell retrieval from liquid nitrogen (LN2) tanks.
• Perform final product visual inspection and cryopreservation in controlled rate freezers.
• Perform biosafety cabinet (BSC) runner duties, including:
  • Balance weight checks and operation.
  • Operation of liquid repeater pump.
  • Operation of tube sealers and welders.
  • Incubator-use for cell culture.
• Perform in-suite environmental monitoring and document duties using a sample management electronic system.
• Train, pass, and maintain gowning qualification.
• Perform logbook review and attend daily Tier 1 meetings to escalate issues.
• Work in a team environment and independently as required.
• 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.
• Adhere to production schedule while maintaining internal production priorities.
• Perform other duties as assigned.

Requirements

• 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 (preferred).
• Must be able to read, write, and understand English, especially for Good Documentation Practices.
• Proficiency in Microsoft Office (Excel, Word, Outlook, and Teams).
• Ability to accurately perform arithmetic calculations, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
• Quality mindset, familiar with 21 CFR Part 11, standard GxP best practices, and FDA regulations.
• Ability to build relationships quickly and work successfully in a fast-paced, team-oriented environment.

Skills

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, and analysis.
• Ability to handle work-related stress and multiple priorities simultaneously while meeting deadlines.

Schedule

Rotation Schedule:

• Week 1: Shift B: Thursday to Saturday from 0700 to 1930
• Week 2: Shift B: Wednesday to Saturday from 0700 to 1830

Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training will occur during regular workweek hours (1st shift Monday-Friday). Once trained, technicians will be assigned to shifts that may include weekends, evenings, and holidays (e.g., Sunday to Wednesday, Wednesday to Saturday, days or nights). Overtime may be required.

Physical Demands

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), including scrubs, gowning coveralls, masks, and gloves.
• Must meet requirements for and be able to wear a half-faced respirator for use with hazardous chemicals.
• Able to stand and/or walk 90% (and sit 10%) of the 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 up to 50 pounds.

For the Visual Inspection Program, the technician must pass a Vision Exam that includes:

• 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.

Work Environment

• This position works in both an office and a manufacturing setting.
• When in the cleanroom, must work with various chemical/biochemical exposures using appropriate PPE.
• Potential exposure to noise, equipment hazards, and strong odors.