Aseptic Manufacturing Technician I

Essential Functions and 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:
Provide operational support functions including:
Materials stocking and transfer.
Kit preparation.
Room readiness.
Equipment cleaning activities.
And 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.
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.
Ability to work in a team environment and independently as required.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Must comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Adherence to production schedule while maintaining internal production priorities.
Perform other duties as assigned.
Required Education, Skills, and Knowledge

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.

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, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.
Physical Demands and Activities Required:

You 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-faced respirator for use of hazardous chemicals.
Able to stand and/or walk 90% (and sit 10%) within your 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 50 pounds.
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 cleanroom setting, must be able to work with various chemical/biochemical exposures with appropriate PPE.
Potential exposure to noise and equipment hazards and strong odors.