NOVRJP00011757 Cell Processing Specialist (m/f/d)
For an international pharmaceutical company with headquarters in Basel, we are looking for new team members for their site in Stein (AG) as
Cell Processing Specialist (m/f/d)
Temporary employment, 100%
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.
You will also be 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.
Tasks & 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
Ideal profile
• Bachelor’s degree in a relevant Engineering or Scientific discipline with a minimum of 1 year practical experience with aseptic or cell culture experience OR
• If no university degree: a minimum 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
• Ability to adapt and learn new and complex equipment and systems and detailed scientific content
• Ability to collaborate with other groups, teams and departments in addressing process related issues in a highly diverse environment
General information
• Start date: asap
• Duration of employment: planned for now for 1 year
• Place of work: Stein AG (on-site)
• Workload: 100% (shift work)
Your application
If you are interested in this position, please apply online or send your resume in English to:
Write an email
If you have any questions in advance, you can also reach Philipp Kleinbruckner by phone at:
+41 (0)79 124 54 63
We look forward to hearing from you.
