Senior External Manufacturing Director

Vor 5 Tagen

Wien, Wien, Österreich Valneva Vollzeit

About Us


Valneva is 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 to commercialize three vaccines, including the world's first and only chikungunya vaccine, and rapidly advance a broad range of vaccine candidates into and through the clinic.



Job Overview

The role of Senior External Manufacturing Manager (m/f/d) - CTM is responsible for collaborating with internal departments such as R&D, Clinical, Quality, and Supply Chain on key responsibilities:



  • Drug Substance Process Management
  • Technological Transfer & Scale-Up
  • Supply Chain & Planning
  • Supplier Relationship Management
  • Project Management

You will oversee tasks such as managing clinical trial materials production through external partners and Contract Development and Manufacturing Organizations (CDMOs).


The ideal candidate should have experience in Drug Substance manufacturing, tech transfer, and scale-up processes with CDMOs, and be familiar with biopharmaceutical manufacturing processes.



Key Responsibilities

  • Manage timelines and resources effectively to ensure on-time delivery of all materials while maintaining high-quality and compliance standards.
  • 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.

The successful candidate will also contribute to providing technical documentation for regulatory submissions and audits.



Requirements

  • Advanced degree in Chemical Engineering, Biochemistry, Biotechnology, or related field.
  • Minimum 5-7 years of experience in Drug Substance manufacturing in the pharmaceutical or biotech industry.
  • 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.

A strong team player with excellent communication skills, you will be able to work effectively in a multicultural environment.



Benefits

  • Competitive salary: €65,000 per year based on full-time employment.
  • Attractive benefits package including flexitime, compensation days, performance-related bonus, lunch vouchers, child care center, company events, and more.

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