5 Ingénieur Commercial Stellen in Aarau gefunden

For our pharmaceutical partner, Kelly Life Science is looking for a:
Cell Processing Specialist
(Temporary contract - 1 year)

Your mission:

• Responsible for operations on day 0, cell washing and harvest processing
• Reponsible for verifying cell processing associates on intermediate processing days of patient derived clinical and commercial cellular immunotherapy products
• Responsible for the formulation and verification of all media lots
• Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation

Your responsibilities:

• Ownership for the processing of the assigned patient starting material in clean room environment
• Ability to gown aseptically and work in a clean room environment (A, B and C) areas for extended periods of time
• Day 0, cell washing and harvest processing with the ability to work with automated equipment such as the CS5 and Sepax
• Verification of intermediate process days which include expertise with wave bioreactor, NC-200 and in process environmental monitoring
• Maintenance and preparation of equipment/environment for use
• Use of production related IT systems such as SAP, LIMS and MES
• Documentation of all steps in assigned Batch record in line with GMP requirements
• Conduct all necessary processing/verification steps for the assigned lot with highest skill level of 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 GOPs, SOPs and aseptic techniques, gowning qualifications and other relevant training including HSE for the specific role
• Maintenance of "audit ready" module
• Perform other duties as assigned; i.e. batch record review, process streamline improvements, safety walks

Your profile:

• Bachelor's degree in a relevant Engineering or Scientific discipline
• Min of 2 years' experience in cGMP or academic or lab setting with aseptic or cell culture experience
• Ability to perform complex calculations and an understanding of scientific notations required
• Experience in cell therapy manufacturing, aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas, cell expansion using incubators and single use bioreactors, cell automated equipment
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Fluent in English
• Ability to work in 6/4 shift model, 2-2-2 (early/day/late)
• Physical fitness and ability to high concentration
• Careful handling of chemicals such as corrosives, solvents & bio-hazardous materials

Your contact at Kelly:
Manon Tenaud +41 22 737 12 07