Aseptic Manufacturing Technician I - Day Shift A [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).

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:
• Materials stocking and transfer.
• Kit preparation.
• Room readiness.
• Equipment cleaning activities.
• 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.
• Able to perform 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.

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 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.

Qualifications

• 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.

Skills

• 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.

Benefits

N/A

Pay

N/A

Schedule

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.