Clinical Operations Manager (f/m/d)

  • Position: Full time
  • Open Date: May 12, 2022 8:09 AM
  • Location: Vienna, Austria

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 all aspects of one or more phase 1-4 clinical studies from protocol through clinical study report finalization for regulatory submission.
  • Ensures compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicable.
  • Ensures all operational study deliverables are met according to timelines, budget, operational procedures, and quality standards.
  • Manages CROs and other external partners and ensures adherence to scope of work within timelines and budget.
  • Interacts with other departments and relevant functional areas.

YOUR QUALIFICATIONS

  • Academic education, Master or PhD degree (Life Science)
  • Minimum of 3 years of clinical management experience
  • Profound knowledge of ICH-GCP, data protection laws, clinical trial directive and other regulations and guidelines relevant for the conduct of clinical trials
  • Ideally experience in the field of vaccine development
  • Supervisory/managerial experience in clinical development including supervision of CROs and/ or CRAs is a must
  • Team oriented
  • Excellent communication, presentation, interpersonal, independent problem solving, financial management and leadership skills
  • Organized and independent work style with strong systematic approach to prioritization but still detail oriented
  • Excellent command of English (spoken and written)
  • Excellent computer skills
  • May be required to travel to supervise and coordinate clinical studies

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 € 60.000,00  gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Apply Now

Regulatory Affairs Manager (f/m/d)

  • Position: Full time
  • Open Date: May 10, 2022 8:11 AM
  • Location: Vienna, Austria

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

  • 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

  • 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 € 45.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Apply Now

Accountant (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Open Date: May 3, 2022 12:42 PM
  • Location: Vienna, Austria

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

  • Processing of incoming invoices with Readsoft Online (OCR-tool for importing e-invoices into ExFlow)
  • Preparing & posting invoices within the ERP-System (MS Dynamics AX2012/ExFlow)
  • Close cooperation and communication with the Procurement department regarding PO invoice postings
  • Vendor correspondence (reminders, bank account changes, audit letters & others)
  • Support of testing for ERP modifications
  • Support in IFRS month- and quarter-end closing activities
  • Preparation of various reports and documentation related to SOX
  • Vacation replacement for Accounting Team Members

Your qualifications

 

  • Graduate from a commercial school or bachelor degree (e.g. HAK)
  • At least 2 years of professional experience in Accounting (favorably in an international environment and with ERP-System knowledge)
  • Good knowledge of MS Office, especially Excel, as well as initial experience with AX desirable
  • Very good written and spoken English skills, German is a plus
  • Strong numerical skills, ability to work in a team and precise working style
  • IT and ERP affinity

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, combination of home office and office work, performance-related bonus, lunch vouchers, childcare center (“Kindergarten”), company events

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.

Apply Now

Senior Technical Assistant QC Analytics Austria (f/m/d)

  • Position: Full time
  • Open Date: May 2, 2022 11:45 AM
  • Location: Vienna, Austria

 

Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

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, Revision und Verifizierung analytischer Daten
  • Erstellung, Revision und Überprüfung der GMP-relevanten Dokumenten (zB 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
  • Zumindest 4 Jahre Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen 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

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 Mindestgehalt von EUR 40.000,- brutto pro Jahr (Vollzeitbasis) gilt.

Apply Now

Technical Assistant QC Analytics Austria (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Open Date: May 2, 2022 10:15 AM
  • Location: Vienna, Austria

Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

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.

Apply Now

Technical Assistant QC Analytics (f/m/d)

  • Position: Full time
  • Open Date: May 2, 2022 9:33 AM
  • Location: Vienna, Austria

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.

Apply Now

Logistics Specialist (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Open Date: Apr 15, 2022 10:14 AM
  • Location: Vienna, Austria

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

  • Executing the receipt, handling and storage of materials, equipment, IMPs and other material required for
    Valneva Austria according to current regulations and procedures
  • Maintenance of stock levels
  • Organizing, monitoring and reporting transport activities for materials and equipment at Valneva Vienna Site
  • Monitoring transport temperature data and reporting incidents
  • Performing regular stock checks, equipment qualifications and calibration activities
  • Working actively on harmonization and proposing changes to increase efficiency of processes or utilization of space

YOUR QUALIFICATIONS

  • Graduation from a commercial/technical school (HAK, HTL)
  • At least 5 years relevant cross functional work experience in a regulated industry, preferably within the logistics/warehouse area
  • Highly organized with strong systematic approach to prioritization
  • Excellent interpersonal skills and ability to work flexibly in a small and focused team
  • Capability to work in a fast-changing environment
  • MS Office skills and experience with an ERP-System (preferably MS-Dynamics AX)
  • Excellent interpersonal skills and ability to work flexibly in a small and focused team
  • Knowledge on customs procedures
  • 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 € 30.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Apply Now

Head of Quality Control (f/m/d) (Vienna, Austria)

  • Position: Full time
  • Open Date: Apr 1, 2022 11:53 AM
  • Location: Vienna, Austria

FIXED-TERM CONTRACT (1,5 years)

YOUR RESPONSIBILITIES

  • Site functional lead for Quality Control (QC) of marketed products. Lead and develop local site QC team Local line management responsibilities for QC Analytics (QCA) and Sample Management Departments (20 employees). Site Quality Control responsibilities including QC testing (release, stability, and raw material) and management of samples.
  • Coordinate in vivo experiments with Laboratory Animal Facility and ensure compliant set-up in vivo QC testing (release and stability).
  • Assure compliance with cGMP of all QC facilities, equipment, systems, and processes
  • Keep up to date with current GMP guidelines, relevant pharmacopoeia and scientific knowledge in respect to QC testing requirement and methods.
  • Technical oversight of tech transfer and all external QC testing activities.
  • Assure that external and internal regulations for Environment, Health and Safety are fulfilled for all QC staff, facilities, systems and processes.
  • Responsible for review/approval of QC test data, and QC-batch/sample result release, including trending, sample related deviations, Out of specification (OOS) and Out of control (OOC) investigation and timely escalation.
  • Responsible for providing technical expertise support from QC to investigations and technical matters.
  • Responsible for QCA test plans and internal QC resource planning to ensure timely delivery of QC results.
  • Responsible for defining and maintaining the direct cost budget for the QC cost centers
  • Review and approval of specifications, validation and qualification documents, as well as standard operation procedures of analytical methods and sample management
  • Responsible for QC employees to have the necessary qualification, practical experience and competency.
  • Responsible for premise and equipment to be maintained to suit its intended purpose

YOUR QUALIFICATIONS

  • Bachelor or Master Degree in Natural Sciences, with extensive work experience in the Life Science or Pharmaceutical Industry,
  • Minimum of 5 years’ work experience within GxP regulated Life Science or Pharmaceutical Industry
  • Experience of relevant GxP (GMP, GCP, GCLP) requirements for QC for the EU, US and Canadian markets in a commercial environment
  • Used to work in an international environment with various cultures is desirable
  • Strong management and leadership skills with ability to motivate and engage
  • Proactive, solution-oriented and able to react in a fast changing environment
  • Ability to manage and prioritize workload both for the organization as well as on a personal level
  • Business fluent 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 € 65.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Apply Now