Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Coordinate and participate in preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, INDs) to competent authorities worldwide for approved and developmental products
  • Operate electronic submission tools (eCTD manager, validation tools) and electronic Data Management Systems (eDMS) used at Valneva Austria GmbH
  • Develop content, timelines and contingencies for submissions in collaboration with internal and external contributors
  • Ensure that submissions are of high quality, meet all regulatory requirements and are in compliance with corporate goals and directives
  • Provide regulatory feedback in project teams
  • Participate in contacting competent authorities for respective projects/products and interact with internal departments
  • General regulatory and maintenance tasks

YOUR QUALIFICATIONS

  • University degree in science and/or regulatory affairs
  • 4 – 5 years’ experience in Pharmaceutical industry preferably with vaccines
  • 1-2 years experience in Regulatory affairs
  • Experience in Regulatory Life Cycle Management and eCTD is an advantage, although not required
  • Excellent English and German skills
  • Proficiency with standard Windows and Office programs
  • Experience with electronic document management systems and IT knowledge
  • Good social skills and ability to work in teams

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 45.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Valneva est une société spécialisée dans le développement et la commercialisation de vaccins prophylactiques contre des maladies infectieuses générant d’importants besoins médicaux. Le Groupe a mis à profit son expertise et ses infrastructures pour commercialiser avec succès deux vaccins et pour faire rapidement progresser un large éventail de candidats vaccins en développement clinique, et notamment ses candidats vaccins contre la maladie de Lyme, le virus du chikungunya et la COVID-19.

100% as soon as possible (limited for 1 year)

YOUR RESPONSIBILITIES

  • Supervise development and validation of immunological assays
  • Supervision of GCLP-compliant immunogenicity testing for clinical trials (scientific, technical and organizational aspects)
  • Assay planning, analysis, review, as well as assay maintenance and trouble shooting
  • Writing technical protocols/reports (Assay development and validation, Analytical Plans and Reports) and other GxP documentation
  • Evaluation and presentation of data
  • Provide expertise and support to other functions within the organization
  • Establish, maintain and supervise collaborations with external partners

YOUR QUALIFICATIONS

  • PhD in the fields of Immunology, Virology and/or Microbiology
  • Work experience in the life science industry or experience with clinical studies is a plus
  • Hands-on experience on immunological/biological assays/analytical methods (e.g. ELISA, cell based assays, RT-qPCR)
  • Knowledge in development of assays
  • Experience in an GxP environment is a plus
  • Excellent analytical/problem solving skills
  • Strong organizational and communication skills
  • Fluent English
  • Good presentation techniques
  • Able and used to work under time pressure on multiple projects in a changing environment

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 45.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

YOUR RESPONSIBILITIES

  • Planning, analysis, review and troubleshooting of external pre-clinical animal models
  • Writing and reviewing of technical protocols / reports for external studies
  • Co-ordinate and liaise with external parties regarding pre-clinical animal models and other studies
  • Verification and review of set-up for immunological assays used for assessing pre-clinical vaccine candidates
  • Active participation at various vaccine programs or projects focusing on pre-clinical activities
  • Contribution to selection of new vaccine candidates for pre-clinical and clinical development
  • Build and maintain scientific expertise for dedicated vaccine indication
  • Become an integral part of highly interactive team working on multiple projects
  • Preparation and review of scientific manuscripts for publication

YOUR QUALIFICATIONS

  • PhD in relevant scientific field (preferred: immunology)
  • Several years of work experience in the life science environment
  • Background in vaccinology and animal models
  • Willingness to work in a research as well as GxP-regulated environment
  • Ability to work according to challenging timelines
  • Team work, excellent organizational skills
  • Excellent analytical/problem solving skills
  • Computer software (MS Office ..) and knowledge in statistical analyses
  • Fluent in English (oral and written), fluent in German

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 48.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Responsible for setting-up, monitoring and management of assigned projects (including Valneva development projects, clinical trials, as well as general project management activities) from initiation through completion conduct with a primary focus on milestone achievements
  • Develop full scale integrated project plans
  • Responsible for tracking of project milestones, timelines and budget
  • Secures required resources and uses formal processes and tools to manage resources, budget, risks and changes
  • Carries out operational project controlling regarding time, quality and budget
  • Generate transparency of the projects ensuring routine reporting to the RDOC
  • Lead and co-ordination of virtual project teams cross sites
  • Responsible for management of external stakeholder and aligning with project operational activities

YOUR QUALIFICATIONS

  • Degree/background in natural sciences (HTL, FH, University etc.)
  • Qualification in PM or proven track record in PM
  • Several years of work experience in project management, ideally in the life science environment
  • Detail-oriented and accurate working style
  • Very good communication and computer skills (i.e. Excel, MS Project, etc.)
  • Fluent English
  • Able to work in a team as well as independently
  • Able and used to work under time pressure on multiple projects in a fast changing environment

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 47.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Ihre Aufgaben

  • Erhaltung und laufende Verbesserung der Qualitätssicherungssysteme in allen relevanten Bereichen der Valneva Austria GmbH
  • QA Business Partner/in für spezifische Bereiche/Abteilungen der Valneva Austria GmbH
  • Begleitung von Validierungs- und oder Qualifizierungsprojekten (Geräte, Methoden, Software)
  • Sicherstellung der Einhaltung von SOPs nach GxP und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Aktive Unterstützung der Abteilung bei der Administration der Qualitätssysteme (z.B. Abweichungen, Änderungen, CAPA, etc.)
  • Préparation et révision des documents

Ihre Fähigkeiten

  • Abgeschlossene HTL und/oder Studium (Bachelor, Master oder vergleichbar) in einem relevanten wissenschaftlichen Feld (z.B. Biologie, Biotechnology, Qualitätsmanagement)
  • 2-5 Jahre Berufserfahrung innerhalb der Qualitätssicherung/Qualitätskontrolle und innerhalb eines GMP/GDP regulierten Umfelds
  • Très bonne connaissance des directives BPF / BPD et les exigences réglementaires
  • L'expérience dans l'organisation de la formation pour différents groupes cibles
  • L'expérience dans la création de SOP et GMP / documentation PIB
  • Ausgezeichnete Kommunikationsfähigkeiten, hohe soziale Kompetenz und gewohnt, in einem schnell wachsenden, internationalen Umfeld zu arbeiten
  • Proaktive, problemlösungsorientierte und strukturierte Arbeitsweise
  • Ausgezeichnete Englisch- und Deutschkenntnisse (schriftlich und mündlich)

Unser Angebot

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen
    Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Attraktive Benefits wie beispielsweise flexible Arbeitszeitgestaltung, leistungsorientierter Bonus, Essensgutscheine, Campus-Kindergarten, Company Events

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein KV-Mindestgehalt von EUR 40.000,- brutto pro Jahr (Vollzeitbasis) gilt.

Valneva is a specialty vaccine company focused on prevention against infectious diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

YOUR RESPONSIBILITIES

  • Responsible for sample management for in-house and external release and stability testing for QC departments
  • Organization of Incoming and Outgoing Shipments (Supply Coordinator)
  • Samples storage and distribution for internal testing
  • Maintain oversight and coordination of external testing
  • Maintain communication/contact with external and internal clients
  • Responsible for Purchase Order processing
  • Establishment of in house testing schedule and Certificates of Analyses
  • Archiving/filing of documents according to GMP requirements
  • Support basic lab equipment maintenance and calibration activities

YOUR QUALIFICATIONS

  • Bachelor/HTL degree in natural sciences
  • Excellent organizational, documentation management and teamwork skills required
  • High communicational skills required
  • Working experience in a laboratory or quality (GxP) environment is a plus
  • English fluently in word and writing, Experience with Word and Excel
  • Management and consolidation of large data sets/lists
  • Highly team-orientated personality
  • Willing to work in a high-quality regulated GxP environment

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 34.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

 

 

Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

YOUR RESPONSIBILITIES

  • Execution of diverse analytical procedures (e.g. ELISA, HPLC, UV VIS spectrophotometry, cell based assays, etc.) for testing of release and stability samples for marketed products according to defined standard operating procedures and protocols in compliance with the same
  • Perform routine cell culture
  • Execute lab activities for set up, transfer and validation of assays required for the release of raw materials, intermediate products and final products, including preparation/completion of protocols and reports
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Preparation and review of GMP relevant documentation (e.g. Deviations, Changes, SOPs)
  • Active participation in laboratory investigations and documentation thereof (e.g. in case of Deviations)
  • Assume responsibility for laboratory equipment including qualification thereof and oversight of regular cleaning, calibration and maintenance

YOUR QUALIFICATIONS

  • Bachelor/Master Degree or equivalent level in a relevant scientific field
  • Excellent technical lab skills (immunological assays, cell culture, chemical / biochemical / bioanalytical methods)
  • Experience in cell culture and GxP environment
  • Experience with equipment qualification and method validation is a plus
  • Excellent organizational, documentation management and teamwork skills
  • Proactive, accurate, reliable working style and problem solving skills
  • Ability to work on competing projects with limited resources
  • Team work and excellent organizational skills

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 40.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

Your Responsibilities

  • Setting up, transfer and validation of analytical GMP release and stability tests for multiple projects in the clinical development including preparation/completion of protocols and reports
  • Execution of diverse analytical procedures (e.g. ELISA, HPLC, cell based assays, etc.) as part of quality control testing of products / clinical trial materials according to defined standard operating procedures and protocols and in compliance with the same
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Preparation and review of GMP relevant documentation in English language (e.g. Deviations, Changes, SOPs)
  • La participation active dans les enquêtes de laboratoire et la documentation de celle-ci
  • Assume responsibility for laboratory equipment

Your Qualifications

  • MTA, BTA, DI (FH) or Master of Science in relevant field (Biology, Microbiology, Biotechnology, Bioengineering)
  • Experience working in a laboratory (preferably immunology, virology or biotechnology)
  • Travailler selon GxP dans un système de qualité reconnue est un plus
  • Experience working with cell based methods, ELISA, SDS-Page and/or HPLC is a plus
  • Experience working with the qualification and validation of product
    testing methods is a plus
  • Excellent organizational, documentation management and teamwork
    skills
  • Proactive, accurate, reliable working style and problem solving skills
  • Capacité à travailler sur plusieurs projets avec des échéances difficiles

Notre offre

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Package de rémuneration compétitif.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 34.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

If you are interested in this challenging position, please apply by using the “Apply Now” button below.