Fellow, Drug Product - Manufacturing Sterile Products

Johnson & Johnson Johnson & Johnson · Pharma · Titusville, NJ +2

Johnson & Johnson is seeking a Fellow, Drug Product - Manufacturing Sterile Products to lead global aseptic manufacturing strategies, advance innovative technologies, and guide execution across a complex supply chain. This role requires deep expertise in sterile product manufacturing, compliance guidance, and shaping global concepts for biotherapeutics and parenteral products. The Fellow will collaborate with R&D, Quality, Manufacturing, and external partners, provide technical support for regulatory filings, and participate in industry conferences.

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

  • Minimum of 10 years of relevant work experience
  • Strong expertise in one or more of the following areas: pharmaceutical manufacturing processes, products, and equipment, sterile manufacturing, visual inspection, and/or container closure integrity
  • Proven understanding of Quality & Compliance / regulatory requirements (GMP)