Senior GMP Manufacturing Specialist

4 settimane fa

Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pieno

Evotec Modena Srl 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.

This position will have a key role in the Cell and Gene therapy Manufacturing team to guarantee company and intercompany ATMP manufacturing activities. The successful candidate will be responsible for carrying out ATMP manufacturing in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).

Key Responsibilities:

  • 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 gowning
  • Prepares equipment and raw materials for manufacturing
  • Performs (preparation and execution) aseptic process simulation (media fill)
  • Executes all steps outlined in the batch records
  • Reads and fulfills in real time production batch records and equipment logbooks
  • Assures the cleaning state and routinary maintenance of the manufacturing equipment
  • Immediately 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 management
  • Carries out the work in compliance with company Safety Policies
  • Prepares for production (engineering batch, full scale batch, clinical batch) and identification of batch specific requirements
  • Reports any accidents, incidents and injuries immediately notifying any hazards, unsafe procedures, or conditions in the workplace
  • Keep up to date by participating in training courses and opportunities
  • Participates at writing and revision of SOPs and Manufacturing documents
  • Participate to the quality investigation from production side
  • Participates at Regulatory Authorities audits for aspects pertaining the role
  • Supports the activities for periodic qualification of clean room interacting with QA and engineering
  • Is involved in process-related meetings
  • Collaborates with Process Development team to bring manufacturing process in GMP

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