GMP Manufacturing Specialist

1 giorno fa

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

In the context of Evotec Modena Srl, we are seeking a highly motivated GMP Manufacturing Operator with expertise in aseptic manufacturing to join our Cell and Gene therapy Manufacturing team. This position will play a key role in ensuring the success of our company and intercompany ATMP manufacturing activities.

Key Responsibilities:

  • Carry out ATMP manufacturing in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
  • Execute manufacturing operations in a clean room environment, adhering to cGMP requirements and wearing sterile gowning.
  • Prepare equipment and raw materials for manufacturing.
  • Perform aseptic process simulation (media fill) and execute all steps outlined in the batch records.
  • Read and fulfill production batch records and equipment logbooks in real-time.
  • Ensure the cleaning state and routine maintenance of manufacturing equipment.
  • Immediately report any deviations, errors, or potential matters relevant to manufacturing completion to management.
  • Work in compliance with company Safety Policies.
  • Prepare for production and identify batch-specific requirements.
  • Report accidents, incidents, and injuries, and notify any hazards, unsafe procedures, or conditions in the workplace.
  • Participate in training courses and opportunities to stay up-to-date.
  • Collaborate in writing and revising SOPs and manufacturing documents.
  • Participate in quality investigations from a production perspective.
  • Participate in Regulatory Authorities audits related to the role.
  • Support periodic clean room qualification activities, interacting with QA and Engineering.
  • Be involved in process-related meetings.
  • Collaborate with the Process Development team to bring manufacturing processes into GMP compliance.

Required Skills & Abilities:

  • Knowledge of current GMP guidelines, particularly GMP for ATMPs.
  • Ability to successfully gown into aseptic manufacturing areas.
  • Positive team player and problem-solving attitude.
  • Accurate, with excellent prioritization and organization skills.
  • Commitment to assigned deadlines and ability to deliver tightly.
  • Scientific English intermediate level is required (written and spoken).
  • Good knowledge of Microsoft Office applications.

Education:

  • MS Degree in Biomedical Laboratory Techniques/Biotechnology/Biology.

Experience:

  • Pharma/Biotech aseptic Manufacturing Operator (1+ years).
  • Experience in clean room environments.
  • Previous experience in cell culture is mandatory.
  • Previous experience with iPSC is a plus.

Evotec Modena Srl is an equal opportunities employer and welcomes applications from all qualified candidates, including those with disabilities.

  • GMP Manufacturing Specialist

    2 settimane fa

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

    Evotec Modena Srl is seeking a highly skilled GMP Manufacturing Specialist to join our Cell and Gene Therapy Manufacturing team. As a key member of our team, you will be responsible for ensuring the successful execution of ATMP manufacturing activities in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).Key...

  • GMP Manufacturing Specialist

    3 settimane fa

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

    Evotec Modena Srl is seeking a highly skilled GMP Manufacturing Specialist to join our Cell and Gene Therapy Manufacturing team. The successful candidate will be responsible for ensuring the compliance of our manufacturing processes with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).Key Responsibilities:Carry out ATMP...

  • GMP Manufacturing Specialist

    4 settimane fa

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

    Job Title: GMP Manufacturing OperatorEvotec Modena Srl is seeking a highly motivated GMP Manufacturing Operator to join our Cell and Gene therapy Manufacturing team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our manufacturing processes.Key Responsibilities:Carry out ATMP manufacturing in compliance with...

  • GMP Manufacturing Specialist

    4 settimane fa

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

    Job Title: GMP Manufacturing OperatorEvotec Modena Srl is seeking a highly motivated GMP Manufacturing Operator to join our Cell and Gene therapy Manufacturing team in Modena. As a key member of our team, you will be responsible for ensuring the quality and compliance of our manufacturing processes.Key Responsibilities:Carry out ATMP manufacturing in...

  • GMP Manufacturing Specialist

    7 giorni fa

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

    Job SummaryEvotec Modena Srl is seeking a highly motivated GMP Manufacturing Operator to join our team in Modena. As a key member of our Cell and Gene therapy Manufacturing team, you will be responsible for ensuring the successful execution of ATMP manufacturing activities.Key ResponsibilitiesCarrying out ATMP manufacturing in compliance with Good...

  • Senior GMP Manufacturing Specialist

    2 settimane fa

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

    Evotec Modena Srl is a leading company in the discovery and development of novel small molecule drugs. We are seeking a highly motivated GMP Manufacturing Specialist to join our team in Modena.This position will play a key role in our Cell and Gene Therapy Manufacturing team, ensuring the successful execution of ATMP manufacturing activities in compliance...

  • GMP Manufacturing Specialist

    2 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.The Company intends to develop best-in-class...

  • Senior GMP Manufacturing Specialist

    4 settimane fa

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

    Job Title: Senior GMP Manufacturing OperatorEvotec Modena Srl is seeking a highly skilled Senior GMP Manufacturing Operator to join our Cell and Gene Therapy Manufacturing team in Modena. As a key member of our team, you will be responsible for ensuring the successful execution of ATMP manufacturing activities in compliance with Good Manufacturing Practices...

  • Senior GMP Manufacturing Specialist

    2 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...

  • GMP Compliance Specialist

    2 mesi fa

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

    Evotec is at the forefront of discovering and developing innovative small molecule therapeutics, with operational facilities across Europe and the United States. The company has established a robust expertise in drug discovery and development, utilizing an industrialized platform to propel new small molecule compounds into clinical settings. Furthermore,...

  • ATMP Manufacturing Expert

    16 ore fa

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

    Job DescriptionEvotec Modena Srl is seeking a highly skilled ATMP Manufacturing Expert to join our cell therapy manufacturing team in Modena. The ideal candidate will have expertise in aseptic manufacturing and be able to execute ATMP manufacturing in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).Key...

  • Quality Assurance Specialist

    2 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...

  • Quality Assurance Specialist

    1 mese fa

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

    **About Evotec Modena Srl**Evotec Modena Srl is a leading biotechnology company specializing in the discovery and development of novel small molecule drugs. With operational sites in Europe and the US, the company has built substantial expertise in drug discovery and development, as well as an industrialized platform for driving new innovative small molecule...

  • Quality Assurance Specialist

    2 mesi 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...

  • Manufacturing Specialist

    1 giorno fa

    Modena, Emilia-Romagna, Italia Angelo Po Grandi Cucine S.P.A. A tempo pieno

    About Angelo Po Grandi Cucine S.P.A.We're a company committed to attracting and retaining top talent, driven by people with the aptitude, attitude, and entrepreneurial spirit. Our team focuses on manufacturing excellence, ensuring high-quality products.Job SummaryCandidates will work on fitting mechanical parts and subassemblies into different types of...

  • Quality Assurance Specialist

    7 giorni 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...

  • Advanced Manufacturing Press Line Specialist

    4 settimane fa

    Modena, Emilia-Romagna, Italia Manpowergroup A tempo pieno

    Advanced Manufacturing Press Line Set-upSei un professionista esperto nell'allestimento e nella configurazione di linee di pressatura avanzate? Sei appassionato di lavorazione dei metalli e desideri lavorare in un ambiente dinamico e all'avanguardia? Siamo alla ricerca di un professionista motivato e appassionato di tecnologia per unirsi al nostro team di...

  • Quality Assurance Specialist

    1 mese fa

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

    Evotec Modena Srl is a leading company 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.We are looking for a highly...

  • Specialista di Produzione Lean Junior

    2 settimane fa

    Modena, Emilia-Romagna, Italia Granterre Spa A tempo pieno

    Descrizione del LavoroIl Gruppo GranTerre Spa è alla ricerca di un Specialista di Produzione Lean Junior per potenziare il team di Lean Production.La risorsa si occuperà dell'implementazione delle attività di Miglioramento Continuo e dei piani per ottimizzare i processi e le operazioni nei reparti industriali attraverso strategie, strumenti e metodologie...

  • Industrial Controlling Specialist

    3 settimane fa

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

    We are seeking a highly skilled Industrial Controlling Specialist to join our team at Gchconsulting Srl. In this role, you will be responsible for monitoring and analyzing the financial key performance indicators of our plant, ensuring compliance with Group accounting rules, IFRS, and local statutory requirements.You will work closely with the plant manager...