Aseptic Manufacturing Technician II Contract to Hire
Aseptic Manufacturing Technician II Contract to Hire
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Job Description
Iovance Biotherapeutics is an immunooncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL).
The Aseptic Manufacturing Technician II 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 II you will primarily be responsible for handson cell processing using single use high density bioreactors Bio Safety Cabinets (BSCs) cell count machines cell wash and concentration machines tube welders and sealers for commercial and clinical use. Other duties include environmental monitoring cell culturing and liquid transfers. Role primarily takes place in grade B (ISO7 and Grade A (ISO5.
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.
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 MF); 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) May be required to work overtime.
Essential Functions and Responsibilities:
- Develop a comprehensive understanding of and be able to proficiently execute Iovances 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).
Primary Responsibilities:
o Grade B/ISO 7/Bench:
- Performs cell counts utilizing cell counting machines.
- Operates cell wash and concentration machines
- Harvesting/seeding single use high density bioreactors
- Perform aseptic tube welding sealing and connections
- Aseptic liquid transfer.
- Performs and verifies mathematical calculations
- Measures and weighs for inprocess materials.
- Collect and submit inprocess samples.
- Escalates inprocess issues to Batch Runner.
o Grade A/ISO 5 Processing:
- Able to train pass and maintain APQs (Aseptic Process Qualifications).
- Aseptic manipulations within the Biological Safety Cabinet (BSC) for several hours at a time.
- Final formulation/filling of final product.
- Media preparation.
- Tumor processing
- Sample collection.
- Escalates inprocess issues to Batch Runner.
Secondary Responsibilities:
o EM:
- Perform insuite environmental monitoring during the day of process
- Perform document Environmental Monitoring duties using sample management electronic system.
o 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 used for cell culture.
o 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.
o Miscellaneous:
- Perform realtime document review including executed Batch Records and Logbooks.
- Able to train pass and maintain gowning qualification.
- 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.
- Quality mindset familiar with 21 CFR Part 11 standard GxP best practices and FDA regulations.
- Adherence to production schedule while maintaining internal production priorities.
- Provide operational support functions including materials stocking and transfer room readiness and equipment maintenance.
- Support documentation needs which include a review of SOPs Work Instructions and Forms.
- Facilitate comprehensive training sessions as an individual contributor. Ensure clear concise guidance and maintain meticulous training documentation adhering to strict Good Documentation Practices (GDPs).
- Support departmental projects in a contributor capacity.
- Completes recording of data to comply with regulatory requirements.
- Proactive results oriented selfstarter with experience in a complex manufacturing environment.
- Perform miscellaneous duties as assigned.
Required Education Skills and Knowledge
- Bachelors degree or equivalent experience.
- Minimum1 years of experience in biopharmaceuticalbased GMP manufacturing operations including aseptic technique aseptic liquid transfers use of welders and sealers BSC aseptic operations and associated downstream processing is a plus.
- Ability to perform arithmetic calculations accurately and reproducibly including fractions decimals percentages and basic algebraic and geometric calculations.
- Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
- Ability to mentor and provide best practices to new technicians.
- Must be able to read write and understand English especially for Good Documentation Practices.
- Proficient in Microsoft (Excel Word Outlook and Teams).
- 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 fastpaced teamoriented environment and manage constant change.
Preferred Education Skills and Knowledge
- Experience in biopharmaceuticalbased GMP manufacturing operations including experience in cell culture and associated downstream processing including but not limited to cell culture single use high density bioreactors Bio Safety Cabinets (BSCs) cell count machines liquid transfers cell wash and concentration machines tube welders and sealers controlled rate freezers grade B (ISO7 gowning and liquid nitrogen amongst others.
- Quality mindset familiar with 21 CFR Part 11 and standard GxP best practices and FDA.
- Proactive resultsoriented selfstarter with experience in a complex manufacturing environment.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations 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 midrange 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:
- 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 halfface 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 problemsolving analysis and discretion; ability to handle workrelated 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 including latex and bleach.
- Potential exposure to noise and equipment hazards and strong odors.
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 equalopportunity employer our employees and applicants will be considered without regard to an individuals 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 for one of our opportunities please contact .
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 ourCandidate Privacy Notice.
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Required Experience:
Senior IC
Employment Type
Contract
