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JOB DESCRIPTION:

The Plant Microbiologist, Sassenheim is responsible for providing microbiological and aseptic oversight and contamination control of the production of Lentivirus products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

KEY CAPABILITIES, KNOWLEDGE, AND SKILLS:

• Aseptic processing in ISO 5 clean room and biosafety cabinets
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
• Detailed knowledge of the shop floor manufacturing process.
• Comprehensive knowledge of trending using statistical analysis.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
• Ability to summarize and present results, and experience with team-based collaborations is a must.

OPLEIDING / EDUCATION:

Education: A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required. Experience within the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing is required, preferably in clinical quality, method development, cell banking, cell therapy, or Research & Development.

• Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products.
• Define specific aseptic techniques to be performed for crucial process steps and provide meaningful input to processing operations.
• Review and approve relevant QC documents, SOP’s and WI’s.
• Ensure microbiological control strategy is consistent with cGMP and Janssen requirements
• Set up validation and routine monitoring environmental sampling program
• Play a lead and proactive role in the design, maintenance and delivery of Operations aseptic technique and microbiology awareness training program. In conjunction with manufacturing help improve training related to microbiological hygiene and contamination prevention.
• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
• Actively support process microbiological investigations.
• Drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene.
• Identify risks and opportunities in relation to contamination control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators, QC and operations management.
• Periodic review of site trends (Utilities) and support identification of appropriate corrective and preventative actions as required. (I.e. critical utilities team).
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.