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

  • Regular updates of existing SOPs owned by Clinical Development
  • Development of new clinical SOPs
  • Training of Clinical Development team on clinical SOPs
  • Organization of relevant trainings, including GCP
  • Audit Coordinating Person for Clinical Development
  • Coordination and support of clinical regulatory inspections in collaboration with QA
  • May participation in clinical audits and regulatory inspections

YOUR QUALIFICATIONS

  • At least 3 years of clinical operations experience or clinical quality assurance
  • Profound knowledge of ICH-GCP, data protection laws, clinical study directives and other regulations and guidelines for the conduct of clinical studies
  • Experience in holding trainings
  • Strong organization and communication skills
  • Attention to detail
  • Independent working style
  • Excellent knowledge in English (written and oral)
  • May be required to travel to participate in audits/inspections

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 € 42.000,- 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

  • Assay planning, analysis, review and troubleshooting of established routine methodologies (scientific, technical and organizational aspects)
  • Writing technical protocols / reports (assay development and validation, analytical testing) SOPs and other GxP documentation
  • Verification and validation of assays used for release and stability testing as well as validation of computerized systems
  • Qualification of analytical equipment
  • Assay set up and transfer for the release of raw materials, intermediate products and final products, including preparation / completion of protocols and reports
  • Execution of analytical procedures, for testing of test, release and stability samples, according to defined Standard Operating Procedures, and protocols in compliance with the same
  • Compliance with and continuous improvement of best cGMP working standards
  • Deviation and change management
  • Co-ordinate and liaise with external companies regarding QC activities

YOUR QUALIFICATIONS

  • PhD in relevant scientific field (preferred: chemistry)
  • Background in chemical assays (e.g. HPLC, ICP-OES, Photometric assays)
  • Willingness to work in a GxP-regulated environment
  • Ability to work according to challenging timelines
  • Team work, excellent organizational skills
  • Excellent analytical/problem solving skills
  • Computer software and analysis (MS Office, SPSS)
  • Fluent in English (oral and written)

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 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

  • 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 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

  • 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 € 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)
  • Active participation in laboratory investigations and documentation thereof
  • 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)
  • Working according to GxP within a recognized quality system is a 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
  • 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.

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