Production Operator Cell & Gene Therapy (m/w/d)

LINK KOPIEREN

Our customer, a pharmaceutical company in the Stein area, needs reinforcements. For a long-term temporary position with options to a permament position, we are looking for several 

Production Operator Cell & Gene Therapy (m/w/d)

Job Purpose:
You are responsible for operations on Day 0, cell washing and Harvest processing and for verifying cell processing associates on intermediate processing days of patient derived clinical and commercial cellular immunotherapy
products. Cell processing specialist will also be responsible for the formulation and verification of all media lots. 

Major accountabilities:

  • Processing of the assigned Patient starting material in the clean room environment (A, B and C)
  • Cell washing and Harvest processing with automated equipment such as the CS5 and Sepax
  • Verification of intermediate process days with wave bioreactors, NC-200 and in process environmental monitoring
  • Maintains and prepare equipment/environment for production related IT systems such as SAP, LIMS and MES
  • Documentation of all steps in the assigned Batch record in line with GMP requirements
  • Conduct all necessary processing/verification steps for the assigned lot with aseptic technique
  • Assist on Deviation Investigations and Inspections
  • Participation in assigned qualification/ validation activities
  • Responsible for successful on-time completion of required training curriculum
  • Comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role
  • Other duties as assigned; i.e. batch record review, process streamline improvements, safety walks

Ideal Backround:

  • Aprrenticeship or study in Scientific discipline e.g. Lab Technician, Scientist, Chemical technician, CTA or similar
  • Alternative technical apprentice with Lab, aseptic, cell culture or production experience in GMP area 
  • Experience in Aseptic processing in ISO 5 biosafety cabinets is a plus
  • Universal precautions for handling human derived materials in BSL-2 containment areas
  • Fluent in English

Challenges:

  • Ability to work in 6/4 shift model without night shift, 2-2-2 (early – day – late)
  • Ability to lift 20 kg unassisted
  • You need to be a teamplayer
  • Ability to take on a vast level of responsibility (you are holding lifes in your hands)
  • In possesion of a level of concentration & focus to be able to work in a strongly regulated environment
  • Capable of working up to 5 hours in a hygiene level A zone (no drinking nor toilet breaks)

What are your perspectives:

  • You will work temporarily for one year - if you perform well you will be taken on by the client
  • You willl work within a highly respected environment and will be able to develop a unique skillset
  • You can make a difference and create direct impact on patients lives
  • Effective working hours only 30 hours per week (at at 100% pensum)

Would you like to know more about the job? Then send your application to Ms Marica Hug. 

Zellen Gen Therapie Vollzeit Schichtarbeit Shift Biosample Aargau Permanent