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Aseptic Manufacturing Technician I - Day Shift A [Contract to Hire]
Philadelphia, Pennsylvania, United States · On-site
Entry level$1.6B raised
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating …
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Full-time, Contract
bachelor degree
Posted 17d ago
~40 hrs/week
Responsibilities
The Aseptic Manufacturing Technician is responsible for executing cell therapy manufacturing processes, including suite preparation, material transfer, and environmental monitoring. They also perform final product inspection and cryopreservation while adhering to strict GMP and safety standards.
Requirements
Candidates must have a bachelor's degree or equivalent experience, with a preference for 0-1 years in biopharmaceutical GMP manufacturing. Proficiency in aseptic techniques and the ability to work in a fast-paced, team-oriented environment are essential.
Full job description
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Overview
Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL).
The Aseptic Manufacturing Technician I, role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.
As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use.
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.
As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.
Rotation Schedule:
Week 1: Shift A: Sunday to Wednesday from 0700 to 1830
Week 2 Shift A: Sunday to Tuesday from 0700 to 1930
Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday days or nights). May be required to work overtime.
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.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
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.
#LI-onsite
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected].
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
Related keywords
Aseptic ManufacturingCell TherapyTumor Infiltrating LymphocytesGMPSOPGDPISO Class 5CleanroomCryopreservationEnvironmental MonitoringBiosafety CabinetLiquid Nitrogen21 CFR Part 11GxPFDA RegulationsBiopharmaceutical
Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
2007
Headquarters
San Carlos, California
LinkedIn followers
39,248
Total funding
$1.6B
Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer.
We are adding to our talented team as we execute our commercial launch, advance our research and development efforts, and build our internal manufacturing capabilities. Iovance is headquartered in the San Francisco Bay Area. Our Iovance Cell Therapy Center (iCTC), a state-of-the-art manufacturing facility, is located in Philadelphia. We also have a research site in Tampa, Florida.
Any information expressed by Iovance is subject to the risk factors and information on forward-looking statements contained in its filings with the Securities and Exchange Commission and available here: https://ir.iovance.com/sec-filings
Offices: 825 Industrial Rd, Suite 400, San Carlos, California 94070, US · 3802 Spectrum Blvd, Tampa, Florida 33612, US · 300 Rouse Blvd, Philadelphia, Pennsylvania 19112, US · 700 Spring Garden St, Philadelphia, Pennsylvania 19123, US · Gustav Mahlerlaan 1212, NoMa House, Amsterdam, North Holland 1081 LA, NL
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