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

Iovance Biotherapeutics•Philadelphia, PA

13d•Onsite

About The Position

Iovance Biotherapeutics is an immuno-oncology company developing and commercializing cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The Aseptic Manufacturing Technician I supports the autologous cell therapy manufacturing program by carrying out manufacturing processes for commercial and clinical use. Core activities include suite preparation for cell processing, material transfer, environmental monitoring, biosafety cabinet (BSC) runner duties, final product visual inspection, and final product cryopreservation in controlled rate freezers. The technician develops proficiency in Iovance’s GMP cell therapy manufacturing processes, completes training and maintains training records, and follows quality requirements, GMP, SOPs, and Good Documentation Practices. The position includes duties across preparation, hallway material handling, BSC operations, and environmental monitoring. Technicians work their assigned rotation, with initial onboarding during regular weekday first-shift hours; after training, shifts may include weekends, evenings, and holidays, and overtime may be required. The position works in both office and manufacturing settings. In cleanrooms, the technician may encounter chemical or biochemical exposures, noise, equipment hazards, and strong odors, and must use appropriate PPE. The role has stated visual acuity and color perception requirements for final product inspection, as well as physical requirements including prolonged standing or walking, repetitive movement, and lifting and carrying objects weighing up to 50 pounds.

Requirements

Bachelor’s degree or equivalent experience.
Must be able to read, write, and understand English, particularly for Good Documentation Practices.
Proficiency with Microsoft Excel, Word, Outlook, and Teams.
Ability to perform accurate and reproducible arithmetic calculations, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
Ability to use judgment to resolve operational issues on moderately complex assignments without negatively affecting manufacturing efforts.
Quality mindset and familiarity with 21 CFR Part 11, standard GxP best practices, and FDA regulations.
Ability to build relationships quickly and credibly and work successfully in a fast-paced, team-oriented environment while managing change.
Must pass a vision exam for the Visual Inspection Program; must not be color blind and must have correctable 20/20 near vision in both eyes. Near- and mid-range clarity, depth perception, and color identification may be assessed.
Ability to wear cleanroom attire and PPE, including scrubs, gowning coveralls, masks, and gloves, and to meet requirements for wearing a half-faced respirator for hazardous chemical use.
Ability to stand or walk for 90% and sit for 10% of the scheduled workday, potentially including climbing ladders or steps.
Ability to crouch, bend, twist, reach, and perform repetitive motions.
Ability to lift and carry objects weighing 50 pounds.
Clear and conceptual thinking, judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress, multiple priorities, and deadlines.

Nice To Haves

0–1 year of experience in biopharmaceutical GMP manufacturing operations, including aseptic technique, aseptic liquid transfers, use of welders and sealers, BSC aseptic operations, and associated downstream processing.
Background in cell culture, aseptic gowning and qualifications, and ISO Class 5 (Grade A) cleanroom operations.

Responsibilities

Develop a comprehensive understanding of and proficiently execute Iovance’s GMP cell therapy manufacturing processes.
Complete training sessions and maintain training documentation.
Follow quality standards, GMP, SOPs, and Good Documentation Practices.
Stock and transfer materials, prepare kits, ensure room readiness, clean equipment, and conduct inventory transactions using electronic inventory systems.
Transfer materials, receive tumors, complete Chain of Information and Chain of Custody transactions, perform material incubation, and retrieve feeder cells from liquid nitrogen tanks.
Perform final product visual inspection and cryopreserve final product in controlled rate freezers.
Perform assigned BSC runner duties, balance weight checks, and operate balance equipment, liquid repeater pumps, tube sealers, and welders.
Use incubators for cell culture.
Perform in-suite environmental monitoring on process days and document monitoring using the sample management electronic system.
Train for, pass, and maintain gowning qualification.
Review logbooks and attend daily Tier 1 meetings, escalating issues and concerns to Area Management for further investigation.
Work independently and as part of a team, adhere to production schedules and priorities, and follow company values, policies, business ethics, safety procedures, SDS sheets, laboratory procedures, and OSHA regulations.
Perform other duties as assigned.