Car-T Operations Technical Lead

il y a 2 jours


Gent, Belgique Start People Temps plein

Functieomschrijving The Operations Technical Lead Clean Room is an exempt-level position within the Technical Operations team, responsible for coordinating specific aspects of daily personalized cell therapy production in a sterile cGMP environment. This role involves leading and co-executing process operations, ensuring compliance with standard operating procedures, and maintaining a safe manufacturing environment. The Technical Lead Clean Room will collaborate with cross-functional teams to address production issues, support quality aspects, and contribute to continuous improvement initiatives.

Responsibilities:

1. Lead CAR-T process units, ensuring SOP and cGMP compliance.
2. Build partnerships with cross-functional teams, addressing production issues.
3. Manage quality aspects, review documentation, and act as an SME for audits.
4. Communicate KPIs related to quality in Production.
5. Provide guidance on the production floor, supporting Tech Transfer plans.
6. Contribute to process development and continuous improvements.
7. Assist in investigations and personnel training.
8. Lead daily shift meetings, assign tasks, and collaborate for personnel development.
9. Ensure safe and compliant manufacturing operations within a team environment.

Profiel Requirements:

1. Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or related field, or equivalent experience.
2. Minimum 2 years of operations experience in cGMP or ATMP environments.
3. At least 2 years of aseptic/grade C GMP manufacturing experience.
4. Minimum 1 year of team or project leadership experience.
5. Familiarity with cGMP regulations, EMEA guidance for cell-based product manufacturing, and cleanroom behaviors.
6. Strong leadership, communication, and influencing skills.
7. Ability to work independently, prioritize tasks, and manage multiple responsibilities.
8. Organizational skills for managing shifting priorities in a dynamic environment.
9. Analytical, problem-solving, and pragmatic critical thinking skills.
10. Positive "Can-Do" attitude, Right-First-Time mentality, and hands-on approach.
11. Tenacity to drive issues to resolution and deliver results.
12. Self-motivated, enthusiastic team player with a desire to learn and train juniors.
13. Clear verbal and written communication skills with attention to detail.
14. Proficiency with Microsoft Office tools required; MES/EBR proficiency is a plus.
15. Willingness to work shifts, including evenings, weekends, and unplanned overtime.

Aanbod

You will join an exciting pharmaceutical company with opportunities for growth. You will work within a strong and respectful diverse team where everyone is welcome. You will receive an attractive salary package including meal vouchers and eco vouchers. Hospitalization insurance, group insurance, and bonus are part of the package. You work in a 2-shift system (6h - 16h / 14h - 00h) in a regime in which you work 4 days, have 4 days off, etc. This gives you a good balance between work and private life. You will work in an environment where loyalty and team spirit are highly valued.

#J-18808-Ljbffr



  • Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **ROLE OVERVIEW** The CAR-T Operations...


  • Gent, Belgique Start People Gent (Orban) Temps plein

    Description The Operations Technical Lead Clean Room is an exempt-level position within the Technical Operations team, responsible for coordinating specific aspects of daily personalized cell therapy production in a sterile cGMP environment. This role involves leading and co-executing process operations, ensuring compliance with standard operating...

  • Quality System Lead

    Il y a 6 mois


    Gent, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Quality System Lead for the CAR-T hub in Europe. The position will be based in Beerse or Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s...

  • Car-t Operations Expert

    Il y a 5 mois


    Gent, Belgique MindCapture Temps plein

    CAR-T OPERATIONS EXPERT - Biotech- GhentABOUT THE COMPANY Join a global biotechnology company committed to treating and ultimately curing life-threatening diseases. They are at the forefront of developing advanced cell therapies utilizing diverse technology platforms. These include autologous and allogeneic chimeric antigen receptor T-cell, T-cell receptor,...


  • Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer...

  • Car-t Training Expert

    Il y a 2 mois


    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer...


  • Gent, Belgique Johnson & Johnson Temps plein

    As the Autologous CART operations director, you are accountable for the Operations of the Ghent Obelisc cell processing business unit, and this in close collaboration with our partner Legend Biotech.- In a challenging, fast-paced environment, you play a central role in the organization, collaborating with various other functions (quality assurance, quality...


  • Gent, Belgique Oxford Global Resources Temps plein

    **Manufacturing Operations Lead - Advanced Therapies**: - Location: Ghent, Belgium - Contact: Dardo Helpers - Job type: Contract - Contact phone: +32 15 445 852 - Industry: Pharmaceutical Lead the operational charge in building and scaling two innovative biological manufacturing centers, shaping the future of immunotherapy and directly impacting the...


  • Gent, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA/QP Manager for the CAR-T hub in Europe.- CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the...


  • Gent, Belgique MindCapture Temps plein

    TECHNICAL LEAD CLEAN ROOM - Biotech- GhentABOUT THE COMPANY The Technical Lead for Clean Room Operations will play a critical role in ensuring seamless daily production tasks within Manufacturing Operations. This role involves building strong partnerships across various departments, including Quality Control, Quality Assurance, Facilities & Engineering,...

  • Operations Lead

    il y a 1 semaine


    Gent, Belgique OTIV Temps plein

    **Who we are** OTIV is a Ghent-based company leading the autonomous revolution in rail. We are on a mission to increase safety and efficiency in railway operations by teaching rail vehicles to drive autonomously. By making trains more efficient and safer, we actively contribute to a modal shift and a greener future. We bring this vision to life through a...


  • Gent, Belgique Oxford Global Resources Temps plein

    Location: Ghent, Belgium - Contact: Dardo Helpers - Job type: Contract - Contact phone: +32 15 445 852 - Industry: Pharmaceutical Lead the operational charge in building and scaling two innovative biological manufacturing centers, shaping the future of immunotherapy and directly impacting the trajectory of patient health **Job description** We are seeking...


  • Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer...


  • Gent, Belgique Legend Biotech EU Temps plein

    Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...


  • Gent, Belgique Tbwa ChiatDay Inc Temps plein

    Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based...


  • Gent, Belgique Johnson & Johnson Temps plein

    Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Batch Advocate For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our...


  • Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview** The Technical Support...


  • Gent, Belgique Itineris Temps plein

    **Function**: The Technical Solutions Architect is **the technical lead of the project from concept to delivery & acceptance, with focus on interfacing and infrastructure. **The TSA maps current client architecture with future (UMAX & Azure) architecture, develops and documents the **current and future technical architectures**,** **challenges the...


  • Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe. **CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T-cells and are engineered to...


  • Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a Sr QA Associate, QA Operations/Project Support Lead for the CAR-T hub in Europe. The position will be based in Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created...