Biotech Manufacturing Director
Vor 5 Tagen
At Valneva, we are dedicated to developing and commercializing prophylactic vaccines for infectious diseases.
We have successfully leveraged our expertise to commercialize three vaccines, including the world's first chikungunya vaccine, and advance a range of vaccine candidates into and through clinical trials, addressing unmet medical needs in areas such as Lyme disease, Shigella, and Zika.
About This RoleWe are seeking an experienced External Manufacturing Manager (m/f/d) - CTM to join our team in Vienna. As a key member of our team, you will collaborate closely with internal departments, including R&D, Clinical, Quality, and Supply Chain, focusing on drug substance process management, technological transfer and scale-up, supply chain planning, supplier relationship management, and project management.
In this role, you will oversee the manufacturing of Clinical Trial Materials (CTM) through external partners and Contract Development and Manufacturing Organizations (CDMOs). You will lead Drug Substance (DS) production, ensuring efficient scale-up and tech transfer of DS processes from lab to clinical and commercial manufacturing scales. Additionally, you will act as the primary liaison between internal technical teams and external CDMOs to guarantee high-quality, GxP/GMP-compliant production for clinical trials.
This position requires strong project management skills, with the ability to handle multiple projects and external partnerships effectively. You will adapt project planning and associated costs according to specific clinical phase requirements to ensure successful CTM supply. Moreover, you will manage timelines and resources efficiently to guarantee on-time delivery of all materials, upholding the highest standards of quality and compliance.
We are looking for a candidate with advanced degree (Master's or PhD) in Chemical Engineering, Biochemistry, Biotechnology, or a related field. A minimum of 5-7 years of experience in Drug Substance (DS) manufacturing is required, preferably in the pharmaceutical or biotech industry, with a focus on clinical or commercial supply.
Your profile should include 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, is essential. Good knowledge of regulatory and quality compliance standards, especially GMP, is also necessary.
Experience supporting regulatory submissions (INDs, BLAs) and global regulatory filings, as well as excellent project management skills, are highly valued. Ability to work collaboratively with international teams, showing sensitivity to different cultures and practices, is also crucial.
What We Offer
Working at Valneva means being part of a global bio-tech company with a strong vision to make an impact in the world. Our benefits package includes:
- Work-Life Balance: flexible working hours and five additional compensation days annually
- Financial Perks: performance-related bonus and lunch vouchers
- Lifelong Learning: unlimited access to LinkedIn Learning and German/English courses for free
- Health & Wellbeing: free access to sports and fitness activities via myClubs
The estimated annual salary for this position is €95,000 based on full-time employment, considering the market-oriented salary range and qualifications required for the role.
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