Usp Expert R&d and Gmp

Il y a 6 mois


Gosselies, Belgique Thermo Fisher Scientific Temps plein

Mission

Key responsibilities:
Strategic
- Enable the design and implementation of robust and scalable manufacturing process in line with customers and regulatory authorities’ expectations.
- Raise technical excellence and innovation within the department.
- Participate in ensuring department goals and metrics meet or exceed expectations.
- Identify initiatives and investments with significant impact on department objectives.

Operational
- Closely collaborate with (senior) scientists within the team to drive the design and implementation of robust and scalable manufacturing process from development to commercialization.
- Interact with DSP (DownStream Process) & AD (Analytical Development) to ensure holistic approach.
- Maintain up-to-date knowledge of viral vectors manufacturing and provide recommendation regarding process innovation and improvement, data management solutions, new equipment and raw materials.
- Perform review of process flow, footprint, batch records, process data (parameters and outputs). Identify potential risks or trends and recommend process improvements or mitigation plans when needed.
- Provide technical expertise for process readiness and risks assessments including: Facility Fit Gap Assessments (FFGA), critical process parameters and raw materials Risk Assessment, Failure Mode and Effects Analysis (FMEA).
- Provide technical expertise to design supportive studies such hold times definition, stability testing, shelf-life definition, cleaning strategy, re-use and lifetime definition, bacterial challenge test, media fill test, container integrity test, mixing and homogeneity, extractible & leachable, viral clearance.
- Support deviation investigations, identify relevant Corrective and/or Prevention Actions (CAPAs), and Change Controls when applicable.
- Ensure harmonization of manufacturing solutions (incl. assemblies, buffers) from R&D to GMP,
- Provide technical support to business team in their interactions with customers among which: design of scope of work, timelines and costs definition.
- Act as a coach with junior people and participate in developing technical skills across the department.
- Adhere to Quality standards, cGMP requirements and EHS practices.

Education and skills
- Master/Ph D degree in a life sciences or Chemical Engineering discipline and a minimum of 6 years of relevant experience in Process development, transfer, characterization, validation and life cycle management for biologics, vaccines or cell/gene therapy.
- Knowledge in biostatistics and analytical methods
- Strong leadership skills and ability to work cross-boundaries.
- Excellent written and verbal communication skills at all levels in the organization.
- Language skills: French and English
- Promote a productive and cooperative climate by engaging in a trusting, supportive partnership with others, and solve conflicts in a constructive manner that allows win/win solution.



  • Gosselies, Belgique Thermo Fisher Scientific Temps plein

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Principaux domaines de responsabilité** - Développement et accroissement des activités analytiques_ - Définir, organiser et mettre en place le panel analytique nécessaire au projet, ce compris les transferts de méthodes clients, l’optimisation de méthodes déjà...

  • Cmc Drug Product Leader

    Il y a 6 mois


    Gosselies, Belgique iTeos Therapeutics Temps plein

    **ABOUT ITEOS THERAPEUTICS, INC** iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig...

  • Data Integrity Sr Leader

    Il y a 6 mois


    Gosselies, Belgique Catalent Temps plein

    **Position Summary** Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organization, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services,...


  • Gosselies, Belgique Thermo Fisher Scientific Temps plein

    Ce type d'installation doit se conformer aux règles et réglementations des BPF établies par les ministères de la santé et de la protection sociale des pays, ainsi qu'aux directives internationales. Pour renforcer nos activités R&D de développement analytique basées sur le site de Gosselies, Belgique, nous sommes à la recherche d’un profil de...

  • Technicien de Production

    Il y a 4 mois


    Gosselies, Belgique Start People Temps plein

    En tant que Technicien(ne) de Production Pharmaceutique, vous jouerez un rôle essentiel dans l'exécution des activités de terrain, en respectant strictement les normes GMP. Vous serez responsable de superviser et de participer aux opérations de production, en garantissant la conformité aux procédures et aux réglementations en...

  • Expert BPMn

    Il y a 7 mois


    Gosselies, Belgique ATCON GLOBAL Temps plein

    **Location**:Gosselies(1 day/week onsite) **Languages**: French **Employment Type**: Freelance **Start Date**: ASAP **Context of the mission / Objective(s) of the job** Looking for a Business Analyst/BPMN Expert, in order to model business processes as part of the company's transformation projects. This expert will be part of a centralized unit already in...


  • Gosselies, Belgique Catalent Temps plein

    Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are...

  • Technical Leader

    Il y a 6 mois


    Gosselies, Belgique Catalent Temps plein

    Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas...

  • Business Analyst

    Il y a 6 mois


    Gosselies, Belgique AbAKUS IT Solutions Temps plein

    **Mission**: As a Business Analyst/Expert BPMN, your mission will involve modeling crucial business processes for the company's transformation projects. This opportunity provides a balance between on-site work in Gosselies and the flexibility of telecommuting, with a minimum required on-site presence of at least 1 day per week. **You will be responsible...

  • Production Specialist

    Il y a 6 mois


    Gosselies, Belgique Catalent Temps plein

    Basée à Gosselies, la mission de Catalent Cell and Gene Therapy est de fournir des capacités d'industrialisation de processus optimisées aux organismes de thérapie cellulaire, et d'accélérer l'arrivée de leurs thérapies sur le marché. De la sélection des technologies à la modélisation commerciale, en passant par la fabrication selon les BPF, le...

  • Director, Marketing

    Il y a 2 mois


    Gosselies, Belgique Thermo Fisher Scientific Temps plein

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion...


  • Gosselies, Belgique Thermo Fisher Scientific Temps plein

    **Généralités** - Respecter les Valeurs de la société. - Participer aux réunions nécessaires à la fonction. - Appliquer les outils et les méthodes définis par le groupe. - Respecter les normes de sécurité et de biosécurité en vigueur. - Faire des propositions d’améliorations et d’optimisations structurelles et organisationnelles. -...


  • Gosselies, Belgique Start People Temps plein

    A la recherche d’un nouveau challenge en production pharmaceutique ? Nous avons le job taillé pour vous : Opérateur de production en zones aseptiques. Basé à Gosselies, Catalent Cell & Gene Therapy est actuellement à la recherche d'un Opérateur de production en zones aseptiques. Relevant du département de production, vous serez responsable de...


  • Gosselies, Belgique Catalent Temps plein

    Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are...


  • Gosselies, Belgique Sparagus Temps plein

    This is a full-time assignment, estimated to last a minimum of 6 months (renewable), ideally starting on October 1. In consultation with the manager, part of the assignment can be carried out from home, but a minimum presence of 2 days per week on the Gosselies site is mandatory. Additional days of on-site presence may be requested from the consultant,...

  • Technical Buyer Fr/eng

    Il y a 7 mois


    Gosselies, Belgique HAYS Temps plein

    Direct Technical Buyer - FR/ENG - freelance mission - min. 4 months - Gosselies Your new company Our client is a global life sciences company that develops breakthrough technologies and services. **Your new role** You will work on the one-time delivery of components/services for their labs and production facilities: - Define and implement optimal...

  • QA System

    Il y a 6 mois


    Gosselies, Belgique Catalent Temps plein

    **The Role** Ensure the maintenance and the improvement of the Quality Management system and the compliance with applicable US/EU regulations, guidances and Catalent policies/procedures. Bring the appropriate support to Quality Assurance manager regarding the design, effective implementation, monitoring and maintenance of the quality management system of...

  • Procurement Manager

    Il y a 6 mois


    Gosselies, Belgique iTeos Therapeutics Temps plein

    **iTeos Therapeutics **is a publicly-held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR)...

  • Procurement Manager

    Il y a 6 mois


    Gosselies, Belgique iTeos Therapeutics Temps plein

    **ABOUT ITEOS THERAPEUTICS, INC** iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig...

  • Finance Manager

    Il y a 2 mois


    Gosselies, Belgique Catalent Temps plein

    Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are...