Project Manager Tech Transfer

Merck Merck · Pharma · North Brabant, Netherlands

Project Manager for Technology Transfer of new veterinary biopharmaceutical products from R&D to commercial manufacturing sites. Responsibilities include leading cross-functional teams, ensuring on-time and right-first-time product transfers, providing technical leadership, supporting regulatory submissions, managing project budgets and timelines, and leading technical investigations. Requires 10+ years of experience in a regulated biopharmaceutical environment, strong expertise in technology transfer and GMP regulations, and technical knowledge in biopharmaceutical manufacturing processes.

What you'd actually do

  1. Lead cross-functional teams to deliver technology transfers for new veterinary biopharmaceutical products from R&D into commercial manufacturing.
  2. Partner closely with manufacturing sites, R&D, PTS/ATS, Quality, Supply Chain and Regulatory Affairs to enable on-time, right-first-time product transfers.
  3. Provide technical leadership throughout the transfer lifecycle, including technical reviews and product and process risk assessments.
  4. Support regulatory submission activities by contributing to high-quality technical documentation and building strong collaboration with Regulatory Affairs.
  5. Drive effective project execution through robust planning of budgets, timelines, resources and key milestones for new product transfers.

Skills

Required

  • 10+ years of relevant experience in technology transfer, product development, technical operations, or manufacturing operations within a regulated biopharmaceutical environment
  • BSc, MSc, or PhD in engineering, chemistry, pharmaceutical technology, or a related field
  • Strong expertise in technology transfer methodology and technical problem-solving
  • Well versed in EU and US FDA GMP regulations and guidelines
  • Understanding of key pharmaceutical business processes (change control, deviation management, risk assessments, technical documentation, CMC regulatory processes)
  • Deep technical knowledge in at least one area of biopharmaceutical products and manufacturing processes (solid dosage forms, non-sterile liquids, semi-solids, sterile products, or therapeutic proteins)
  • Effective project leader
  • Clear and confident communication in English
  • Strong relationship building skills
  • Team facilitation, negotiation, and influencing skills

Nice to have

  • Dutch, German, or French is a plus
  • Willingness to travel approximately 25%, mainly within Europe

What the JD emphasized

  • regulated biopharmaceutical environment
  • EU and US FDA GMP regulations and guidelines