Aseptic Manufacturing Technician I - Night Shift B [Contract to Hire] jobs in United States
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Iovance Biotherapeutics, Inc. · 4 hours ago

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

Iovance Biotherapeutics is an immuno-oncology company focused on developing novel cancer immunotherapies. The Aseptic Manufacturing Technician I role is essential for the autologous cell therapy manufacturing program, involving tasks such as suite preparation, material transfer, and final product inspection.

BiotechnologyClinical TrialsHealth CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote

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)
Provide operational support functions including:
Materials stocking and transfer
Kit preparation
Room readiness
Equipment cleaning activities
And inventory transactions using electronic inventory systems
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
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
Perform in-suite environmental monitoring during the day of process
Perform document Environmental Monitoring duties using sample management electronic system
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

Qualification

GMP manufacturing operationsAseptic techniqueBSC aseptic operationsCell cultureMicrosoft ExcelDocumentation PracticesTeamworkProblem-solvingCommunication

Required

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
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
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
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

Company

Iovance Biotherapeutics, Inc.

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Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer.

H1B Sponsorship

Iovance Biotherapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (11)
2023 (7)
2022 (7)
2021 (2)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$1.58B
2024-02-20Post Ipo Equity· $211M
2023-07-10Post Ipo Equity· $150M
2020-05-27Post Ipo Equity· $603.7M

Leadership Team

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Jean-Marc Bellemin
Chief Financial Officer
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Cheryl Aranda
Executive Assistant to Chief Medical Officer
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Company data provided by crunchbase