(Senior) External Manufacturing Manager

vor 1 Woche

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**:
We are currently looking for a motivated** (Senior) External Manufacturing Manager (M/F/d) - CTM **to join our team in **Vienna**. You will collaborate with internal departments such as R&D, Clinical, Quality and Supply Chain focusing on the following key responsibilities: Drug Substance Process, Technological Transfer & Scale-Up, Supply Chain & Planning, Supplier Relationship Management and Project Management. In detail you will be working on tasks such as:

- Oversee and **manage the manufacturing** of Clinical Trial Materials (CTM) through external partners and Contract Development and Manufacturing Organizations (CDMOs)
- **Lead Drug Substance (DS) production**, including efficient scale-up and tech transfer of DS processes from lab to clinical and commercial manufacturing scales
- Act as the primary liaison between internal technical teams and external CDMOs to ensure high-quality, **GxP/GMP-compliant production for clinical trials**:

- Adapt project planning and associated costs according to the specific requirements of each clinical phase to ensure successful CTM supply
- Manage timelines and resources effectively to **ensure on-time delivery of all materials**, while upholding the highest standards of quality and compliance
- Demonstrate flexibility in responding to project changes and **coordinate closely with external partners **to meet key project milestones
- Support regulatory filings, including IND and BLA submissions, ensuring manufacturing data and processes meet global regulatory standards
- Collaborate with internal teams to provide the necessary technical documentation for regulatory submissions, including audits and inspections

**Requirements**:

- Advanced degree (Master's or PhD) in **Chemical Engineering, Biochemistry, Biotechnology** or related field
- Minimum of 5-7 years of experience in **Drug Substance (DS) manufacturing** in the pharmaceutical or biotech industry, with a focus on clinical or commercial supply
- Proven experience in tech transfer and scale-up of DS manufacturing processes with CDMOs
- Strong understanding of **biopharmaceutical manufacturing processes**, including fermentation, cell culture, purification, and analytical techniques
- Good knowledge of regulatory and quality compliance standards, especially GMP
- Experience supporting regulatory submissions (INDs, BLAs) and global regulatory filings
- Excellent **project management skills **with the ability to handle multiple projects and external partnerships
- Experience in vaccine manufacturing or l**arge-scale biological production** is a plus
- Flexible and adaptable, capable of pivoting in response to project changes and unforeseen challenges
- Open-minded, with an **entrepreneurial spirit and proactive approach** to problem-solving and innovation
- Strong **interpersonal and emotional intelligence skills**, able to work effectively in a multicultural, cross-functional environment
- Ability to work collaboratively with international teams, showing sensitivity to different cultures and practices
- **Strategic thinker** with analytical skills for solving technical challenges

**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,...
- 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._

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