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

Iovance Biotherapeutics•Philadelphia, PA

10d•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 and applies knowledge of manufacturing theories, techniques, and principles. Responsibilities include suite preparation for cell processing, material transfer, environmental monitoring, biosafety cabinet (BSC) runner duties, final product inspection, and final product cryopreservation in controlled-rate freezers for commercial and clinical use. Technicians work assigned shifts and may need to work overtime, weekends, and holidays to meet manufacturing needs. Initial onboarding training takes place during regular first-shift weekday hours; after training, technicians are assigned to shifts that may include weekends, evenings, and holidays. The listed Shift B rotation is Thursday through Saturday, 1800–0630, in week one, and Wednesday through Saturday, 1800–0530, in week two. The role works in office and manufacturing settings, including cleanrooms, and involves potential exposure to chemicals, biochemical materials, noise, equipment hazards, and strong odors. Employees must use appropriate cleanroom attire and personal protective equipment, including a half-face respirator when handling hazardous chemicals. The position requires the ability to pass and maintain gowning qualification and, for visual inspection duties, pass a vision exam.

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 accurately and reproducibly perform 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.
Quality mindset and familiarity with 21 CFR Part 11, GxP best practices, and FDA regulations.
Ability to build relationships quickly and credibly and work in a fast-paced, team-oriented environment while managing constant change.
Must be able to pass the visual inspection program’s vision exam: not color blind and have 20/20 near vision in both eyes, with correction permitted; near- and mid-range clarity, depth perception, and color identification may be assessed.
Must be able to wear cleanroom attire and PPE, including a half-face respirator for hazardous chemical use.
Able to stand or walk for 90% and sit for 10% of the workday, potentially including climbing ladders or steps; crouch, bend, twist, reach, and perform repetitive motions; and lift and carry objects weighing 50 pounds.
Must be able to meet the mental demands of clear and conceptual thinking, judgment, troubleshooting, problem-solving, analysis, discretion, handling work-related stress and multiple priorities, and meeting deadlines.

Nice To Haves

Background in cell culture, aseptic gowning and qualifications, and ISO Class 5 (Grade A) cleanroom operations is strongly desired.
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 is a plus.

Responsibilities

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