Fellow, Drug Product - Manufacturing Sterile Products

Johnson & Johnson Johnson & Johnson · Pharma · Beerse, Antwerp, Belgium +2

This role focuses on managing the strategic framework for parenteral biotherapeutics drug products, developing and implementing aseptic manufacturing strategies, and providing expertise in sterile product manufacturing, visual inspection, and container closure integrity. It involves collaborating with R&D, Quality, Manufacturing, and external partners, ensuring compliance with GMP, and supporting regulatory filings and inspections.

What you'd actually do

  1. Manage the strategic framework around parenteral Biotherapeutics Drug Products, in conjunction with other key experts and partners to develop and deploy a JJIM enterprise methodology on a gravel-to-grave process on robust manufacturing of sterile products.
  2. Serve as a Subject Matter Expert (SME) in the global MSAT organization to cover needs for Biotherapeutics and parenteral products with regard to aseptic manufacturing processes, visual inspection, container closure integrity, and related processes.
  3. Shape and continuously improve communities of practices by sharing outstanding knowledge around critical sterile manufacturing practices and concepts across different platforms within JJIM.
  4. Proactively promote quality and compliance in the areas of sterile manufacturing and validation and mentor others to do the same.
  5. Develop and launch innovative concepts for sterile manufacturing technologies by focusing on quality by design and future prospective compliance.

Skills

Required

  • pharmaceutical manufacturing processes
  • sterile manufacturing
  • visual inspection
  • container closure integrity
  • Quality & Compliance / regulatory requirements (GMP)
  • project management

Nice to have

  • Master's or advanced degree (PhD) in a scientific field (Life Science, Pharmacy or Engineering)

What the JD emphasized

  • sterile manufacturing
  • GMP