Emplois actuels liés à Lead Specialist in Process Validation - CorbeilEssonnes, Île-de-France - Yposkesi
-
Process Validation Lead
il y a 3 semaines
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout the RoleYposkesi, a leading Contract Development and Manufacturing Organization (CDMO) for gene therapy viral vector manufacturing, is seeking a highly skilled Process Validation Lead to join its Technical Development group. As a key member of the team, you will be responsible for developing and executing process validation strategies and systems for...
-
Process Validation Lead
il y a 5 jours
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout the RoleAt Yposkesi, we are seeking a skilled Process Validation Lead to join our Technical Development group. This is an exciting opportunity for a professional with expertise in biomanufacturing and process validation to lead projects across the organization.Key ResponsibilitiesDevelop and implement process validation strategies and systems for gene...
-
Process Validation Lead
il y a 4 semaines
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout YposkesiYposkesi is a leading Contract Development and Manufacturing Organization (CDMO) for gene therapy viral vector manufacturing. As a one-stop shop for biotech and pharmaceutical companies, we offer a full range of services in lentiviral vector and AAV (Adeno-Associated Virus) vector development and cGMP manufacturing.Job DescriptionWe are seeking...
-
Process Validation Lead
il y a 3 semaines
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout the RoleYposkesi, an SK pharmteco company, is a leading Contract Development and Manufacturing Organization (CDMO) for gene therapy viral vector manufacturing. As a Process Validation Lead, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes.Key ResponsibilitiesDevelop process validation strategies and...
-
Process Validation Specialist
il y a 4 semaines
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout the RoleWe are seeking a highly skilled Process Validation Lead to join our Technical Development team at Yposkesi. As a key member of our organization, you will be responsible for developing and executing process validation strategies for gene therapy drug substance and drug product manufacturing processes.Key ResponsibilitiesDevelop and implement...
-
Process Validation Specialist
il y a 3 semaines
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout the RoleYposkesi, a leading Contract Development and Manufacturing Organization (CDMO) for gene therapy viral vector manufacturing, is seeking a highly skilled Process Validation Lead to join its Technical Development group. As a key member of the team, you will be responsible for developing and executing process validation strategies and systems for...
-
Process Validation Specialist
Il y a 2 mois
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout the RoleWe are seeking a highly skilled Process Validation Lead to join our Technical Development team at Yposkesi. As a key member of our organization, you will be responsible for developing and executing process validation strategies and systems for our gene therapy manufacturing processes.Key ResponsibilitiesDevelop process validation strategies and...
-
Process Validation Specialist
il y a 4 semaines
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout YposkesiYposkesi, an SK pharmteco company, is a leading Contract Development and Manufacturing Organization (CDMO) for gene therapy viral vector manufacturing in Europe. Our one-stop shop offers a full range of services in lentiviral vector and AAV (Adeno-Associated Virus) vector development and cGMP manufacturing. We are located on the Genopole Campus...
-
Process Validation Specialist
il y a 3 semaines
Corbeil-Essonnes, Île-de-France Yposkesi Temps pleinAbout the RoleYposkesi, a leading Contract Development and Manufacturing Organization (CDMO), is seeking a Process Validation Lead to join its Technical Development group. This role will be responsible for developing process validation strategies and systems for gene therapy drug substance and drug product manufacturing processes.Key ResponsibilitiesDevelop...
-
Chef de projet R&D
il y a 1 mois
Corbeil-Essonnes, Île-de-France NonStop Consulting Temps pleinResponsable R&D - Intégration et validation de systèmes analytiquesNous sommes à la recherche d'un(e) Responsable R&D pour rejoindre notre équipe de développement de solutions de diagnostic In Vitro. Vous serez chargé(e) de la gestion des processus d'intégration, de vérification et de validation des systèmes analytiques.Principales responsabilités...
-
Corbeil-Essonnes, Île-de-France NONSTOP CONSULTING Temps pleinEntrepriseNONSTOP CONSULTING est un cabinet de recrutement primé et en pleine expansion, spécialisé dans plusieurs secteurs et présent en Europe et aux États-Unis.Nous nous engageons à trouver des solutions adaptées aux besoins des clients et des candidats, et nous sommes également une entreprise de formation et de développement axée sur des...
-
Photonic Integrated Circuit Design and Manufacturing Specialist
il y a 4 semaines
Corbeil-Essonnes, Île-de-France Ligentec SA Temps pleinJob DescriptionLIGENTEC SA is a fast-growing European company with headquarters in Lausanne, Switzerland. We have expanded our manufacturing capabilities by creating LIGENTEC France in the South of Paris. We specialize in the design and manufacturing of Photonic Integrated Circuits (PICs) for customers in high-tech areas such as Quantum Technologies, LiDAR,...
-
Systems Administration Lead
il y a 4 semaines
Corbeil-Essonnes, Île-de-France Ligentec SA Temps pleinSystems Administration LeadLigentec SA is seeking an experienced Systems Administration Lead to join our team. The successful candidate will be responsible for managing and administering our IT systems, including servers, networks, and virtual machines. Key responsibilities include: Managing and administering IT systems, including servers, networks, and...
-
Data Management Supply Chain Militaire F/H
il y a 1 mois
Corbeil-Essonnes, Île-de-France Safran Temps pleinJob DescriptionAs a Data Management Specialist for the Military Supply Chain at Safran, you will play a crucial role in ensuring the smooth operation of our supply chain systems. Your mission will be to identify and resolve discrepancies in our data, working closely with our team to implement solutions and improve our processes.Key Responsibilities•...
-
Chef commercial leader
il y a 1 semaine
Corbeil-Essonnes, Île-de-France Cloud Eco Temps pleinPrésentation du poste Nous sommes à la recherche d'un Chef commercial leader pour rejoindre notre équipe à Cloud Eco. Vous serez responsable de la croissance des ventes dans votre secteur, en développant une équipe de commerciaux et en mettant en place des stratégies pour atteindre les objectifs de vente. Vous travaillerez en étroite collaboration...
-
Technical Support Specialist
il y a 4 semaines
Corbeil-Essonnes, Île-de-France Ligentec SA Temps pleinTechnical Support SpecialistWe are looking for a skilled Technical Support Specialist to join our team at Ligentec SA. The successful candidate will be responsible for providing technical support for hardware, software, and network issues, as well as installing, configuring, and maintaining end-user devices. Key responsibilities include: Providing technical...
-
Accounting Specialist
il y a 2 semaines
Corbeil-Essonnes, Île-de-France LE CABRH Temps pleinWe are seeking a highly skilled Accounting Specialist to join our team. In this role, you will be responsible for preparing financial statements, conducting audits, and maintaining accurate financial records.Main Responsibilities:Prepare financial statements and reportsConduct audits and provide recommendations for improvementMaintain accurate financial...
-
Maintenance and Equipment Specialist
il y a 1 jour
Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps pleinJob OverviewX-FAB France SAS is a leading provider of manufacturing services in the field of microelectronic packaging. We are currently seeking a highly skilled Maintenance and Equipment Specialist to join our team.
-
Senior Software Engineer
il y a 2 semaines
Corbeil-Essonnes, Île-de-France Orano Group Temps pleinAbout the Role:We are seeking a highly skilled Senior Software Engineer - Tech Lead to join our team.The ideal candidate will have a strong background in software development and technical leadership, with the ability to motivate and guide a team of engineers to deliver high-quality software solutions.Key Responsibilities:Lead the design and development of...
-
Maintenance Specialist
il y a 3 semaines
Corbeil-Essonnes, Île-de-France X-FAB France SAS Temps pleinJob SummaryAs a Maintenance Technician at X-FAB France SAS, you will play a crucial role in ensuring the smooth operation of our state-of-the-art equipment. Your primary responsibility will be to perform preventive maintenance and curative actions to minimize downtime and maximize productivity.Key Responsibilities• Implement maintenance actions on...
Lead Specialist in Process Validation
Il y a 3 mois
About Us
Yposkesi, a part of SK pharmteco, stands as one of the foremost Contract Development and Manufacturing Organizations (CDMO) in Europe, specializing in the production of gene therapy viral vectors. We serve as a comprehensive partner for biotech and pharmaceutical enterprises aiming to progress clinical trials and bring Advanced Therapy Medicinal Products (ATMPs) to market. Our facility is situated within the Genopole Campus in Corbeil-Essonnes, France, and we are proud to employ around 200 dedicated professionals.
Position Overview
We are seeking a Process Validation Lead to contribute to the dynamic sector of Cell and Gene therapy.
Key Responsibilities
The Process Validation Lead will be an integral member of the Technical Development group, overseeing projects throughout the organization. This role requires a profound knowledge of process validation methodologies and frameworks, focusing on the validation of gene therapy drug substance and drug product manufacturing processes for various client projects at Yposkesi. The primary responsibilities include:
- Formulating and implementing process validation strategies and frameworks for the validation of gene therapy drug substance and drug product manufacturing processes.
- Standardizing methodologies for similar studies across diverse products and projects whenever feasible.
- Drafting, reviewing, and approving essential documentation while executing ProVal studies related to both drug substance (e.g., holding time, resin re-use, PPQ, etc.) and drug product (e.g., APS, E&L, container, etc.) manufacturing.
- Collaborating effectively with various departments, including Manufacturing and Quality.
- Actively participating in the site APS ([DP] Aseptic Process Simulation) committee, which defines and manages the site APS strategy and initiatives.
- Building and leading a process validation team as ProVal activities expand in the coming years.
- Ensuring alignment with client and regulatory expectations regarding the validation of biomanufacturing and gene therapy manufacturing processes.
- Engaging in international consortia (e.g., BioPhorum C) to collaboratively establish best practices for the validation of gene therapy manufacturing processes.
- Representing process validation efforts in discussions with clients, including defining validation strategies and updating on the progress of ongoing studies.
Candidate Profile
The ideal candidate will possess:
- A Master's degree in Biochemical Engineering, Biotechnology, or a related life sciences field.
- 3-5 years of relevant experience in a practical environment, particularly within multi-disciplinary teams that include Quality and Manufacturing/Production Units.
- Proficient oral and written communication skills in English (B2 level) and intermediate proficiency in French (B1 - B2), with the ability to draft standard protocols and provide training in French.
- A solid grasp of biomanufacturing processes, including monoclonal antibodies, vaccines, and cell or gene therapies, with experience in both drug substance and drug product.
- A strong foundation in biomanufacturing process design, development, characterization, and validation, with previous experience in developing process validation strategies.
- An understanding of GMPs and the regulatory landscape for the production of biologics, vaccines, or Advanced Therapeutic Medicinal Products (ATMPs).
- A collaborative mindset, capable of appreciating diverse technical perspectives and aligning on a unified path forward.
- Self-motivation and the ability to work independently as well as part of a team in a matrix environment.
- A client-focused approach, establishing effective and responsive relationships with clients.
- Project management skills, including the ability to outline a project from initiation to completion, develop a plan, track progress, and communicate effectively with stakeholders.
