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, and natural killer cell-based immunotherapies. From their three research and development sites worldwide, they leverage these cutting-edge technologies to discover safe and effective therapeutics for patients globally.

As** Operations Expert,** you will be part of the manufacturing operations team responsible for production of CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.

You will lead and perform multiple units within the process operations (i.e. component preparation manufacturing, manufacturing support operations, CAR-T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.

**RESPONSIBILITIES**

As** CAR-T Operations Expert,** you will direct and be part of the daily CAR-T production in a sterile cGMP environment to support clinical and commercial readiness and supply safety policies, quality systems and cGMP requirements. As CAR-T Operations expert, you will act as Operational Ambassador and:

- Support building the GMP documentation package to ensure timely execution of production operations per cGMP compliance
- Execute production activities common to manufacture clinical & commercial grade ATMPs by aseptic manual process, including isolation, selection, activation, transduction, culture, fill and finish and cryopreservation of cells according to SOPs, batch records and aseptic techniques, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP)
- Work daily in a cleanroom manufacturing environment (Grade A/B/C/D) together with operations personnel on the production floor to provide guidance and perform production tasks as needed to train and help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements
- Manage the daily production planning in a routine production flow.
- Support manufacturing investigations, create/revise operational procedures, including
manufacturing work instructions, master batch records, forms, and support and manage
change controls.
- Build strong partnerships with Planning, Manufacturing & Process Technology, QC,
Maintenance & Engineering, Facility & Utilities, Warehouse and Quality to ensure
seamless execution of daily production tasks
- Acts as Production Expert in the field by training and coaching junior production technicians by i) being their first point of contact for routine operational activities and
troubleshooting operational day to day problems and by ensuring that SOPs and good safety practices are followed, and ii) being the second point of contact for production optimizations in collaboration with MS&T team
- Support to Testing and implementation of various manufacturing execution system
software (e.g. eLiMS, MES, SAP)
- Support the development of manufacturing processes, participate in Lean & Operational excellence projects, and collaborate with MS&T team to drive continuous improvements and efficiencies within CAR-T Operations

REQUIRED COMPETENCES & SKILLS
- Bachelor’s or Master’s degree in Science, Bio-Engineering, BioTechnology, Pharmacy or related field or equivalent experience required.
- A minimum of 3 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.
- A minimum of 3 years experience in aseptic techniques in clean rooms
- Prior experience in manufacturing, quality, or engineering is required
- Strong influence and relationship building skills with an emphasis on teamwork
- Highly developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
- Strong analytical, problem solving, pragmatic and positive critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- Can do attitude, Right first time and Hands-on approach
- Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
- Focus on quality, compliance and detail
- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
- Experience working in

  • Car-t Training Expert

    il y a 1 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...

  • Car-t Operations Support Lead

    Il y a 5 mois

    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...

  • Autologuous Car-t Operations Director

    Il y a 5 mois

    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...

  • Car-t Senior Operations Manager

    il y a 1 semaine

    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...

  • QA/qp Operation Director Car T

    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 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...

  • Operations Investigation Expert

    Il y a 5 mois

    Gent, Belgique MindCapture Temps plein

    OPERATIONS INVESTIGATION EXPERT - Biotechnology- Ghent & remoteWHAT IS OFFERED Bij MindCapture geloven we in sterke, duurzame relaties met onze kandidaten, consultants, recruiters en ondersteunend personeel. We waarderen jouw talent, toewijding en proactieve instelling en belonen dit met aantrekkelijke compensatiepakketten, inclusief competitieve salarissen...

  • Operations Technician

    Il y a 5 mois

    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** As CAR-T Operations...

  • Marketing Operations Expert

    Il y a 3 mois

    Gent, Belgique Aikido Security Temps plein

    We’re taking on the crusty global cyber market, the "no-BS" security platform for devs. In the past, only large enterprises needed to worry about security. Today,cybersecurity has become the top concern of 75% of all CEOs, from startups to enterprises. This means more work for developers, who need to become security experts and ensure their platforms are...

  • Car-t Mfg. System Associate

    Il y a 5 mois

    Gent, Belgique Johnson & Johnson Temps plein

    **CAR-T Mfg. System Associate (MES PAS-X) **=== JOB DESCRIPTION: ===** CAR T‐cells are an innovative approach to eradicate cancer cells by harnessing the power of a patient’s own immune system. BCMA is a protein that is highly expressed on myeloma cells. By targeting BCMA via a CAR‐T approach, CAR‐T therapies may have the potential to redefine the...

  • IT Expert

    Il y a 5 mois

    Gent, Belgique Recruit4Work S.L. Temps plein

    **Join Our Team**: Seeking an Experienced IT Professional in Brussels Are you ready for an international career that offers not just a job, but a journey? Brussels, the heart of Europe, is not only known for its remarkable blend of historic charm and cosmopolitan vibrancy but also as a hub for ambitious IT professionals eager to make their mark. Our...

  • Operations Supervisor Car Logistics Repair

    Il y a 5 mois

    Gent, Belgique Honda Motor Europe Logistics Temps plein

    **Je job als Operations Supervisor** Als een geboren team leader ben je verantwoordelijk voor een vlotte, tijdige en kwalitatieve afhandeling van alle herstellingen aan voertuigen, binnen het Car Logistics team in Gent. **Je haalt energie uit** - Coachen, ondersteunen, motiveren en evalueren van je dynamisch team van voorbereiders, pistoolschilders,...

  • Car-t Training Supervisor

    il y a 1 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...

  • Car-t Mfg Batch Advocate Mgr

    Il y a 5 mois

    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...

  • 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 Batch Record Reviewer

    Il y a 5 mois

    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. **Position Overview** The CAR-T...

  • Car Detailleur Gent

    Il y a 5 mois

    Gent, Belgique Skillflex Temps plein

    **_Met meer dan 15 jaar lang ervaring in de automotive reinigingssector is onze klant de specialist in professionele industriële reiniging van uw voertuig(en)._** **_ Dagelijks beantwoorden de medewerkers, experts in hun vakgebied, de vragen die veel bedrijven en particulieren zich stellen over autoreiniging. Grondige industriële reiniging, polijsten of...

  • Car Detailleur Gent

    Il y a 5 mois

    Gent, Belgique Skillflex Temps plein

    **_Met meer dan 15 jaar lang ervaring in de automotive reinigingssector is onze klant de specialist in professionele industriële reiniging van uw voertuig(en)._** **_ Dagelijks beantwoorden de medewerkers, experts in hun vakgebied, de vragen die veel bedrijven en particulieren zich stellen over autoreiniging. Grondige industriële reiniging, polijsten of...

  • Car Detailleur Mercedes

    Il y a 6 mois

    Gent, Belgique Skillflex Temps plein

    **_Met meer dan 15 jaar lang ervaring in de automotive reinigingssector is onze klant de specialist in professionele industriële reiniging van uw voertuig(en)._** **_ Dagelijks beantwoorden de medewerkers, experts in hun vakgebied, de vragen die veel bedrijven en particulieren zich stellen over autoreiniging. Grondige industriële reiniging, polijsten of...

  • QA Car-t Qualification Lead Emea

    Il y a 7 mois

    Gent, Belgique Johnson & Johnson Temps plein

    **CAR-T QA C&Q Engineer** The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a CAR-T QA C&Q 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....

  • QA Car-t Qualification Lead Emea

    Il y a 6 mois

    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...