External Manufacturing Manager

vor 1 Monat

Wien, Wien, Österreich Valneva Vollzeit

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.

Key Responsibilities

  • 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

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 large-scale biological production is a plus

Additional Requirements

  • 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

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