Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva 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

  • Provide medical writing for clinical and regulatory documents
  • Participate in development of clinical study documents and take over individual clinical study tasks after respective training
  • Support clinical study data analysis and interpretation of clinical trials
  • Organize advisory boards and study committees (Scientific Advisory Boards, DSMBs, Endpoint Adjudication Committees, etc.)
  • Conduct and summarize literature searches and competitive landscape reviews to support decisions on study designs, endpoints, assays, etc.

Your Qualifications

  • PhD in Life Sciences, preferably in Pharmacy or Biology/Molecular Biology; applicants with a Master’s degree and relevant professional experience are also invited to apply
  • Ideally either thesis in an area related to clinical development, vaccines, infectious diseases or immunology, or initial professional experience with clinical development at a CRO or sponsor
  • Strong writing skills
  • Analytical and detail-oriented mind-set
  • Excellent command of English as the main working language
  • Self-organized work style
  • Scientific interest in clinical development of vaccines

Our Offer

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flextime, 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 € 50.000 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

  • Coordinate of work in Department with primary focus on: molecular biology, cell culture, assay development, animal model setup and execution
  • Guide research assistants and support in efficient distribution of workload (knowledge transfer, ensure that standards are met)
  • Plan, analyze, review and troubleshoot experiments
  • Participate actively in various vaccine programs or projects focusing on pre-clinical activities
  • Become an integral part of highly interactive team working on multiple projects
  • Contribute to selection of new vaccine candidates for pre-clinical and clinical development
  • Build and maintain scientific expertise for dedicated vaccine indication
  • Present study results, internally and externally
  • Write and review protocols, research proposals and reports for internal and external studies
  • Prepare and review scientific manuscripts for publication

YOUR QUALIFICATIONS

  • PhD in relevant scientific field (preferred: immunology)
  • More than 5 years of work experience in the life science environment
  • Background in vaccinology and animal models
  • Ability to work according to challenging timelines
  • Team work, excellent organizational skills
  • Excellent analytical/problem solving skills
  • Detailed working style with ability to set priorities
  • Advanced presentation skills for various stakeholders and audiences
  • Computer software (MS Office ..) and knowledge in statistical analyses
  • Fluent in English (oral and written), fluent in German

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits

 

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. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. 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. 

We are looking for a Senior Project Manager to join our team in Vienna:

YOUR RESPONSIBILITIES

  • Responsible for setting-up, monitoring and management of assigned projects (including Valneva development projects like for example COVID-19, 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 combining agile and waterfall methods to the respective needs
  • 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 respective governance bodies
  • Lead and co-ordination of multinational 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

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits

 

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

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung analytischer Daten
  • Erstellung, Revision und Überprüfung von GMP-relevanten Dokumenten (zB Standardarbeitsvorschriften, Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Mehrjährige Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment ist von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen ist von Vorteil
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen ist von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits wie Gleitzeit, Sodexo-Essensgutscheine, leistungsorientierter Bonus, etc.

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 34.000,- brutto pro Jahr (Vollzeitbasis) gilt.

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva 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

  • Setting up, validating, performing, analyzing and documenting assays for immunological monitoring of clinical trials according to GCLP
  • Participation in assay development and qualification/validation of GxP-compliant serological and cellular immune assays under BSL-2 and BSL-3 conditions
  • Performance of equipment qualifications, routine checks and maintenance work according to relevant GxP guidelines
  • Writing and reviewing of GxP relevant documentation in English language (SOPs, deviations etc.)

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)
  • Working according to GxP within a recognized quality system is a plus
  • Accurate and reliable work style
  • Fluent in written and oral English
  • Good MS Office skills (Word and Excel)
  • Ability to work on multiple projects with challenging timelines

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits

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 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

  • Management of QC Analytics. Lead lab team (approx. 6 team members)
  • Implement and validate assays required for GMP release and stability testing according to relevant guidelines (e.g. ICH, FDA; EP, AMBO)
  • Supervise qualification/maintenance of equipment required for GMP release and stability testing according to relevant guidelines (e.g. ICH, FDA; EP; AMBO)
  • Planning and/or supervision of GMP testing including trouble shooting and data analysis.
  • Ensure efficient daily operations by coordinating resource allocations cross functions as needed.
  • Continues process improvements
  • Perform data review/approval/release required for release of raw materials, intermediate and final products
  • Maintain and ensure high quality of method performance
  • Create/review/approve Development Reports, Validation Protocols/Reports, SOPs & related documents
  • Issue, manage and close-out deviations, changes, investigations and CAPAs in a timely and independent manner

YOUR QUALIFICATIONS

Minimum requirements:

  • Completed master or PhD degree in Natural science studies (Biology, Chemistry, Biotechnology, etc.)
  • A minimum of four years GxP experience in the field of pharmaceutical production or quality control
  • Excellent analytical/problem solving skills
  • Excellent leadership, communication, organizational, documentation management and teamwork skills required
  • Good working knowledge of ICH/FDA/EMA/GMP and other applicable regulatory guidelines
  • Confident handling in MS Office
  • Very good German and good English skills
  • Accountability, decision making, ability to work in a team

Desirable requirements:

  • Computerized system validation

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • 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 € 50.000 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

  • Act as main contact between Valneva SCM and CMO
  • Coordinate communication between SCM/QC/QA/CMO
  • Creation of production orders
  • Setup of Masterdata in AX
  • Creation/update of SOP’s
  • Facilitate the shipping of materials from one destination to another
  • Take responsibility for customs-coordination (Import-Export)
  • Execute deviations, changes, quality related documents
  • Oversee inventory of goods at CMO
  • Create Purchase orders in AX
  • Manage supplier contracts with CMO

YOUR QUALIFICATIONS

  • Graduate from a commercial and/or technical school or bachelor degree (HTL, HAK)
  • At least five years of relevant functional work experience in Pharma (regulated) industry, preferably in Logistics function
  • Effective communication abilities, capacity to work in a fast changing environment
  • High self-organizing abilities, social competence, combined with business orientated behavior
  • Independent work style, strategic and analytical (process)-approach
  • Profound knowledge in customs procedures (P36)
  • Knowledge in GMP-procedures
  • Fundamental MS-Office skills and experience with an ERP-System (preferably MS-Dynamics AX)
  • Very good proficiency in English and German

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • 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 € 32.200 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.