Job title:
Scientist (m/f/d) for Vaccine Formulation Development and Fill-Finish
Company
Valneva
Job description
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, Shigella and Zika.ResponsibilitiesWe are currently looking for a (Senior) Scientist (m/f/d) for Drug Product (DP) Manufacturing and Fill and Finish (F&F) to join our team in Vienna. In this role you will support the technical development for DP manufacturing of early stage, late stage and commercial manufacturing of Valneva´s vaccine candidates and commercial products.
- Lab-scale Experimentation & Formulation Development: Plan and execute early/mid-stage experiments for vaccine candidates (e.g., proteins, virus, conjugates) and adjuvants with minimal supervision. Provide data interpretation and recommendations to project teams.
- Drug Product Filling Support: Offer technical support for vaccine filling processes in mid to late-stage development, assisting with a newly built drug product filling line and external CMO partners.
- Scientific & Project Planning: Lead biologic formulation development, drug product process development, primary packaging, technology transfer, scale-up, and validation activities in alignment with project timelines and organizational goals.
- Collaboration & Stakeholder Engagement: Collaborate with internal and external stakeholders, including Valneva Technology departments and external partners, to align priorities across various functional teams.
- Support for Manufacturing & Process Design: Provide technical support for drug product filling across all stages (early, late, and commercial) including process design, scale-up, clinical manufacturing, and review of process changes and deviations.
- Project Management & Risk Assessment: Manage technical aspects of commercial manufacturing, including process improvement, capacity expansion, and new product introductions. Lead risk assessments and implement solutions to address complex manufacturing challenges.
- Due Diligence & Practical Assessments: Support due diligence activities, particularly for parenteral manufacturing, ensuring practical assessments and recommendations.
- Application of Scientific Principles: Use experimental and process modeling approaches to solve challenges across various unit operations, applying scientific and engineering principles.
- Compliance & Documentation: Ensure compliance with GMP guidelines, preparing documentation (BMRs, SOPs, reports, risk assessments, etc.) in accordance with change control policies and Good Documentation Practices (GDP).
Requirements
- PhD in bioprocess manufacturing, biochemistry, biophysics, pharmaceutical technology
- Minimum 5 years of experience in Vaccine or Biologic Product Development
- Highly skilled in parenteral formulation development, lyophilization, suspension, adjuvantation, micro and nanoparticle stabilization, surface adsorption
- Experienced with product development, process tech-transfer, supporting regulatory submissions, handling queries from regulatory authorities
- Knowhow of biophysical characterization techniques such as DLS, UV-Vis, HPLC-SEC and familiar with analytical outcomes of bioanalytical methods such as ELSIA, Western Blot, PRNT etc.
- Significant knowledge and understanding of drug product manufacturing process operations such as mixing, sterile filtration, and aseptic fill/finish, QbD, awareness of primary packaging (vials, pre-filled syringes)
- Knowledge and understanding of cGMP DP manufacturing guidelines and CMC documentation requirements and by various regulatory authorities
- Knowledge and understanding of Good Data Management Practices, statistical analysis of batch process data, PAT
- Fluent in English, German is an advantage
Benefits
- 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, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, myClubs, full access to LinkedIn Learning, etc.
Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 60.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.
Expected salary
€60000 – 90000 per year
Location
Wien
Job date
Wed, 20 Nov 2024 23:09:21 GMT
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