Senior Gmp Manufacturing Operator Modena

Senior Gmp Manufacturing Operator
Modena
Emilia Romagna, Modena

Senior GMP Manufacturing OperatorApply locations Modena time type Full time posted on Posted Yesterday job requisition id JOB ID-11523Evotec 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 FunctionsCarries 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 logbooksPerforms and assures 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 workplaceKeeps up to date by participating in training courses and opportunitiesParticipates in writing and revision of SOPs and Manufacturing documentsParticipates in quality investigation from production sideParticipates in Regulatory Authorities audits for aspects pertaining the roleSupports the activities for periodic qualification of clean room interacting with QA and engineeringIs involved in process-related meetingsCollaborates with Process Development team to bring manufacturing process in GMPRequired Skills AbilitiesKnowledge of current GMP guidelines, especially GMP for ATMPsCompetence in writing of SOPs, Manufacturing Batch recordsExpertise 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 applicationsEducationMS Degree in Biomedical Laboratory Techniques/Biotechnology/BiologyExperiencePharma/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 process from Development to GMP is a plusAbout UsEvotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients.

The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products.

Evotec leverages this "Data-driven RD Autobahn to Cures" for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders.

Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e. g.

neurology, oncology, as well as metabolic and infectious diseases.

Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned RD projects from early discovery to clinical development.

Evotec operates globally with more than 5, 000 highly qualified people.

The Company's 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence.

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