Downstream Senior Process Engineer Lead for Biologics NPI

il y a 7 jours


Toulouse, Occitanie, France Evotec WD Temps plein

About the Role

We are seeking a highly skilled Downstream Senior Process Engineer to lead our New Product Introduction (NPI) team at Just-Evotec Biologics.

As a key member of our multidisciplinary team, you will be responsible for leading activities related to the introduction of new products to our J.POD Toulouse biotherapeutics manufacturing facility.

You will work closely with cross-functional teams to ensure successful process validation and registration activities, as well as provide subject matter expertise to support regulatory and client inspection audits.

Responsibilities

  • Lead Downstream stakeholders in the NPI process to support the start and rapid scale-up of commercial GMP manufacturing activities.
  • Partner with Product and Process Design to coordinate efficient scale-up and transfer operations.
  • Collaborate with Supply Chain to support Bill of Material development and demand planning for new products.
  • Work with Process Engineering and Digital disciplines to conduct facility fit assessments and plans for system updates.
  • Develop high-quality batch records, robust processes, and innovative technology solutions for new product introduction.
  • Act as a subject matter expert to support team members during regulatory and client inspection audits.

Requirements

  • Masters degree in a relevant field or related program with 5-10 years of pharmaceutical/biotech validation experience.
  • Experience with late-stage clinical and/or commercial biologics drug substance manufacturing programs.
  • Proven record of accomplishment in GMP pharmaceutical or biotechnology.
  • Strong background and technical mastery of purification and solution preparation operations using disposable-based manufacturing technologies.
  • Leadership capabilities to contribute to building a high-performing team.

Estimated Salary Range: $120,000 - $150,000 per annum, depending on experience and qualifications.



  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    About Just Evotec Biologics EUJust Evotec Biologics EU is a leading biotech company that specializes in the development and manufacturing of biopharmaceuticals. With a strong focus on innovation and collaboration, we are seeking a highly motivated Senior Biopharmaceutical Process Development Engineer to join our team.Estimated Salary: $120,000 - $180,000 per...

  • Senior Process Engineer

    il y a 7 jours


    Toulouse, Occitanie, France Evote Temps plein

    We are seeking an experienced Senior Process Engineer to lead our New Product Introduction (NPI) program at Just-Evotec Biologics in Toulouse, France. As a key member of our team, you will be responsible for ensuring the successful introduction of new products into our manufacturing facility.The ideal candidate will have a strong background in...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Senior Scientist in Analytical DevelopmentAt Just Evotec Biologics EU, we are seeking a talented Senior Scientist in Analytical Development to join our team.About the Role:As a Senior Scientist in Analytical Development, you will be responsible for developing, qualifying, and implementing analytical methods to support the development and characterization of...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Aperçu de l'offreJust Evotec Biologics EU est à la recherche d'un expert qualifié pour rejoindre son équipe dynamique et multidisciplinaire. Le rôle consiste à garantir la conformité des produits et processus dans le département Assurance Qualité Produits.ResponsabilitésRévision des dossiers de lot de productionCompilation des données et...


  • Toulouse, Occitanie, France ENAC Temps plein

    About the RoleENAC, a leading European aeronautical school, seeks an exceptional Senior Aeronautical Systems Engineer to join their esteemed team. As part of this exciting opportunity, you will work on the FlyHigh Project, developing and deploying a cutting-edge, low-cost, modular, and open-source hybrid UAV (the OpenGeoDrone) for high-resolution glacier...


  • Toulouse, Occitanie, France Sabena Technics Temps plein

    Description du posteAt Sabena Technics, we are seeking an Aircraft Cabin Safety Certification Senior Engineer to join our team in the Design Organisation Approval (SABENA TECHNICS BGC DOA Part 21J.039) in the Aircraft Modification division. As a leader on Aircraft Retrofit market, developing approximately 10 Supplemental Type Certificate & 100 Minor...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Job Description:We are seeking an experienced IT professional to fill the role of Senior Network and Systems Administrator at Just Evotec Biologics EU.Key Responsibilities:Deploy, maintain, and optimize the company's LAN, WAN, and other network equipment and systems.Monitor and troubleshoot network performance and integrity.Configure and manage VPNs,...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Job Title: Cloud and Network Operations SpecialistJob Summary: We are seeking a highly skilled Cloud and Network Operations Specialist to join our dynamic IT team at Just Evotec Biologics EU. The ideal candidate will have a deep understanding of network and systems management, be proactive in identifying and solving challenges, and be eager to optimize our...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Détails de l'offreSalaire estimé : 60 000 € par anJust Evotec Biologics EU est à la recherche d'un spécialiste assurance qualité pour renforcer son équipe.Description du posteL'objectif principal de ce rôle est de garantir que les bonnes pratiques de fabrication sont appliquées aux systèmes informatisés GxP. Vous serez en charge de...

  • Senior Software Engineer

    il y a 4 semaines


    Toulouse, Occitanie, France Samsic Emploi Temps plein

    Job Title: Senior Software Engineer - Full StackJob Summary: We are seeking an experienced Senior Software Engineer - Full Stack to join our team.Key Responsibilities:* Design and develop full-stack applications using a range of programming languages and frameworks.* Collaborate with cross-functional teams to identify and prioritize project requirements.*...


  • Toulouse, Occitanie, France neuco Temps plein

    About the RoleWe are seeking an experienced Technical Lead to join our team at neuco, a world-leading player in the Satellite and NewSpace Sector. As a Senior Remote Sensing Technical Manager, you will support a diverse range of remote sensing projects, conducting procurement processes on behalf of customers.Key Responsibilities:Lead concept and feasibility...


  • Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    The Manufacturing Associate III role at Just Evotec Biologics EU is a challenging and exciting opportunity to contribute to the successful execution of clinical and commercial manufacturing operations.Key ResponsibilitiesExecute process recipes and monitor equipment and processes to ensure compliance with cGMP practices and standard operating...

  • Ingénieur Process Senior

    il y a 7 jours


    Toulouse, Occitanie, France Evotec Temps plein

    Développez vos compétences en validation de procédésL'Ingénieur Process Senior est chargé de la validation des procédés et de l'introduction de nouveaux produits au sein de Just-Evotec. Ce rôle implique une interaction transversale avec toutes les phases du processus NPI (New Product Introduction), allant de l'initiation du projet à la...

  • Site IT Expert

    il y a 4 semaines


    Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

    Job OverviewAs a Site IT Expert at Just Evotec Biologics EU, you will play a vital role in ensuring seamless integration of IT solutions with local business processes, driving efficiency and value addition.Key ResponsibilitiesAct as a bridge between local business and technology teams to translate requirements into actionable IT solutions.Ensure relevant...

  • Senior Navigation Engineer

    il y a 3 semaines


    Toulouse, Occitanie, France ENAC Temps plein

    Job Title: Senior Navigation EngineerCompany Overview:ENAC, École Nationale de l'Aviation Civile, is a leading European university specializing in aeronautical education. Founded 70 years ago, it provides initial and advanced training for professionals in the civil aviation industry.Job Description:This PhD thesis opportunity is co-funded by THALES ALENIA...


  • Toulouse, Occitanie, France airbus Temps plein

    Job Title: Senior Software Engineer with expertise in full-stack developmentWe are looking for a talented Senior Software Engineer to join our team and contribute to the development of our full-stack applications.As a Senior Software Engineer, you will be responsible for designing and developing scalable, efficient, and reliable software systems. You will...


  • Toulouse, Occitanie, France airbus Temps plein

    Job Title: Cryogenic Engineer for Electric PropulsionJob Description:We are seeking a highly skilled Cryogenic Engineer for Electric Propulsion to join our team. As a key member of our multinational team, you will be responsible for developing advanced superconducting and cryogenic powertrain systems for high-power electric propulsion.Key...


  • Toulouse, Occitanie, France Ascendance Ft Temps plein

    Your role as the Senior Quality Director at Ascendance Ft involves leading all quality initiatives across the company, ensuring they meet stringent quality requirements and standards to deliver business and technical milestones. You will set up the quality function using industry best practices, being agile and adapting to the company's needs and size.You...


  • Toulouse, Occitanie, France airbus Temps plein

    Job DescriptionEmbedded Software Development OpportunityAirbus is seeking an experienced Embedded Software Development Engineer to join our team in Toulouse, France. As a key member of our software development team, you will be responsible for designing, developing, and testing embedded software for avionics systems.ResponsibilitiesDevelop and maintain...


  • Toulouse, Occitanie, France Tunon Temps plein

    **About the Role**We are seeking a skilled Senior Software Engineer to join our team and lead the development of our cloud infrastructure. As a key member of our engineering team, you will be responsible for designing, implementing, and maintaining scalable and highly available systems.**Responsibilities*** Design and implement cloud infrastructure...