Senior GMP Manufacturing OperatorEvotec is a leader in the discovery and development of novel small molecule drugs with operational sites in Europe and the US. The Company has built substantial drug discovery and development expertise and an industrialized platform that can drive new innovative small molecule compounds into the clinic. In addition, Evotec is building an integrated platform to deliver iPSC-based therapeutics to patients and an innovative off-the-shelf cell therapy project portfolio. Leveraging these skills and expertise, the Company intends to develop best-in-class differentiated therapeutics and deliver superior science-driven discovery and development alliances with pharmaceutical and biotechnology companies.
For our cell therapy manufacturing site in Modena, we are looking for a highly motivated GMP Manufacturing Operator, expert in aseptic manufacturing. This position will have a key role in Cell and Gene therapy Manufacturing team to guarantee company and intercompany ATMP manufacturing activities.
Essential Functions Carries out the ATMP manufacturing in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)Executes manufacturing operations in clean room, following cGMP requirements and wearing sterile gowningPrepares equipment and raw materials for manufacturingPerforms (preparation and execution) aseptic process simulation (media fill)Executes all steps outlined in the batch recordsReads and fulfills in real-time production batch records and equipment logbooksAssures the cleaning state and routine maintenance of the manufacturing equipmentImmediately reports any deviations occurred during manufacturing execution or preparation, errors in the documentation, or any potential matter relevant for the correct completion of the manufacturing to the managementCarries out the work in compliance with company Safety PoliciesPrepares for production (engineering batch, full-scale batch, clinical batch) and identification of batch-specific requirementsReports any accidents, incidents, and injuries immediately notifying any hazards, unsafe procedures, or conditions in the workplaceKeep up to date by participating in training courses and opportunitiesParticipates in writing and revision of SOPs and Manufacturing documentsParticipate in the quality investigation from the production sideParticipates in Regulatory Authorities audits for aspects pertaining to the roleSupports the activities for periodic qualification of clean room interacting with QA and engineeringIs involved in process-related meetingsCollaborates with the Process Development team to bring the manufacturing process in GMPRequired Skills & Abilities Knowledge of current GMP guidelines, especially GMP for ATMPsCompetence in writing SOPs, Manufacturing Batch recordExpertise in Risk AnalysisDemonstrated ability to successfully gown into aseptic manufacturing areasPositive, team player, and problem-solving attitudeAccurate, with excellent prioritization and organization skillsCommitment to the assigned deadlines and ability to deliver them tightlyScientific English intermediate level is required (written and spoken)Good knowledge of Microsoft Office applicationsEducation MS Degree in Biomedical Laboratory Techniques/Biotechnology/BiologyExperience Pharma/Biotech aseptic Manufacturing Operator (1+ years)Experience in clean room environmentsPrevious experience in cell culture is mandatoryPrevious experience with iPSC is a plusExperience in technology transfer of the process from Development to GMP is a plus
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