GMP Manufacturing Specialist

4 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 Responsibilities:

  • Carry out ATMP manufacturing in compliance with GMP and SOPs
  • Execute manufacturing operations in clean room environments, following 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 batch records
  • Read and fulfill production batch records and equipment logbooks in real-time
  • Assure the cleaning state and routine maintenance of manufacturing equipment
  • Report any deviations, errors, or potential matters relevant to manufacturing to management
  • Carry out work in compliance with company Safety Policies
  • Prepare for production and identify batch-specific requirements
  • Report accidents, incidents, and injuries, and notify hazards, unsafe procedures, or conditions in the workplace
  • Participate in training courses and opportunities to stay up-to-date
  • Contribute to the writing and revision of SOPs and manufacturing documents
  • Participate in quality investigations from a production perspective
  • Participate in Regulatory Authorities audits for aspects related to the role
  • Support periodic qualification of clean rooms, interacting with QA and engineering
  • Be involved in process-related meetings
  • Collaborate with the Process Development team to bring manufacturing processes into GMP

Requirements:

  • Knowledge of current GMP guidelines, especially GMP for ATMPs
  • Demonstrated 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 (written and spoken)
  • Good knowledge of Microsoft Office applications
  • MS Degree in Biomedical Laboratory Techniques/Biotechnology/Biology
  • Pharma/Biotech aseptic Manufacturing Operator experience (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.



  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...

  • ATMP Manufacturing Expert

    2 settimane 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...


  • 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

    2 settimane 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...


  • 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...


  • 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...


  • 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...

  • Specialista MES

    3 settimane fa


    Modena, Emilia-Romagna, Italia Integrated Solutions Srl A tempo pieno

    Descrizione del LavoroIntegrated Solutions Srl è una società giovane e dinamica, attiva nel campo dell'ICT applicata al Manufacturing.Nel nostro head quarter di Torino abbiamo, inoltre, una Business Unit dedicata allo sviluppo e alla progettazione software, con una particolare attenzione alle tematiche di Project Management e metodologia Agile/SCRUM.Per un...

  • IT Application Specialist

    4 settimane fa


    Modena, Emilia-Romagna, Italia Rossi S.P.A. A tempo pieno

    Job Title: IT Application SpecialistCompany Overview:Rossi S.p.A. is a leading manufacturer of gearboxes, gearmotors, and electric motors for various industrial applications.Our company has a strong presence in the global market, with 15 international subsidiaries, five manufacturing plants, and assembly and service centers worldwide.We are a member company...


  • Modena, Emilia-Romagna, Italia Bonsai Technology A tempo pieno

    Bonsai Technology Srl is a leading engineering consulting company in the lithium battery industry with a global presence. We are supporting corporates, start-ups, and worldwide players to join the lithium battery industry in all value chain areas.We are seeking a highly skilled Lithium Battery Project Specialist to join our team. As a key member, you will be...


  • Modena, Emilia-Romagna, Italia Opocrin S.P.A. A tempo pieno

    **Descrizione delRuolo**Il candidato ideale sarà responsabile dell'analisi di materie prime, prodotti intermedi e finiti, seguendo metodi analitici e procedure operative approvate.**Compiti Principali**• Esecuzione di analisi chimiche di routine con tecniche analitiche di base e strumentali;• Compilazione e gestione della documentazione analitica in...


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

    Richiesta di CandidaturaIl Gruppo GranTerre Spa è alla ricerca di un professionista 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 di Lean...


  • Modena, Emilia-Romagna, Italia Capgemini A tempo pieno

    Vuoi esplorare il tuo potenziale? Come Specialista in Qualità R&D presso Capgemini Engineering, ti unirai a un team globale di esperti per aiutare le aziende più innovative del mondo a liberare il loro potenziale. I nostri talenti in tecnologia digitale e software pensano fuori dagli schemi offrendo servizi unici di Ricerca e Sviluppo e ingegneria in tutti...


  • Modena, Emilia-Romagna, Italia Zenit Group Srl A tempo pieno

    About the Role:We are seeking an experienced Electrical Product Engineer to join our engineering team in Modena, Italy. The successful candidate will be responsible for designing new electrical products related to motors and components, with a focus on design and validation.Main Responsibilities:Design electrical components and electric motors for our...


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

    Job Title: Industrial Controlling CoordinatorWe are seeking a highly skilled and experienced Industrial Controlling Coordinator to join our team at Gchconsulting Srl. In this role, you will be responsible for monitoring and analyzing financial key performance indicators, preparing and analyzing budgets, and ensuring timely delivery of reports.About the...