Scientist (M/F/d) for Vaccine Formulation

vor 2 Monaten

Wien, Österreich Valneva Vollzeit

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

**Responsibilities**:

- **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.
- **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._

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