The GMP Production Specialist works in a small manufacturing team on the production of several extracellular vesicle based therapeutic products in a GMP environment under the supervision of the Production Manager. The GMP production specialist can generate new manufacturing procedures and batch records (in English) or revise existing ones to improve the document quality in accordance with GMP guidelines. The position requires close collaboration with other departments (QA, QC, supply chain, …) and limited professional interaction with suppliers, service providers and/or clients.
In order to fulfill his/her role, the GMP Production Specialist:
· Execute manufacturing processes of extracellular vesicle based pharmaceutical products in a cleanroom environment in accordance to the cGMP guidelines and regulations.
· Contemporaneously document manufacturing activities and observations in the applicable records.
· Report deviations from the established standard operating procedures, perform root cause investigation and implement corrective and preventive actions.
· Generate and revise manufacturing procedures (batch records, SOP’s, protocols, reports, …)
· Perform facility and equipment maintenance and cleaning.
· Acquires proficiency in utilizing the EMS alarm system, and be a key contact in the call list for clean room emergencies
· Performs aseptic processes in a grade B cleanroom (tissue processing, cell culture, final filling …)
· Installs, operates and monitors closed system processes in a grade C cleanroom environment.
· Participates in aseptic process simulation activities.
· Assists in qualifying the clean rooms and performs environmental monitoring.
· Is willing to work flexible hours when required for scheduled process activities.
· Schedules and plans their office time to create new GMP documents and/or revise existing ones according to the agreed timelines.
· Ensures the on time delivery of all batch related records and documents to support the batch release process.
· Warns immediately the Production Manager in case of problem or failure
· Double checks data generated by other operators
· Higher vocational education or BSc in biochemistry or biotechnology with at least two years’ experience in a comparable field.
· Experience in mammalian cell culture and aseptic techniques.
· Experience working in a GMP environment and writing procedures is required.
· Pragmatic, solution driven mindset.
· Responsible working attitude, Proactive and autonomous
· Precise and organized.
· Maintains open, effective, constructive and positive communication with colleagues in the team and in other departments.
· English at least B2
· Proficient with MS Office
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EXO Biologics mission is to provide affordable and accessible exosomes therapy to patients with unmet medical needs.