Msat Synthetics Dp External Site Principal Scientist

Johnson & Johnson Johnson & Johnson · Pharma · Beerse, Antwerp, Belgium +1

Johnson & Johnson is seeking a Principal Scientist for their MSAT Synthetics Drug Product External Site team. This role involves providing technical oversight to external manufacturing sites, including due diligence, auditing, and onboarding. Responsibilities include technical/risk assessment for New Product Introduction (NPI), technical transfers, and Product Life Cycle (LCM) management, as well as deploying new technologies and performing statistical analysis. The scientist will act as a primary technical contact for external manufacturers and ensure compliance with quality and regulatory standards.

What you'd actually do

  1. Handle execution of drug product technology transfer, product life cycle activities, material qualification, and cleaning validation
  2. Support NPI using applicable tools and standards in collaboration with Virtual Management Team (VMT), key supply chain functions, Technical launch integrators / owners, and EM site
  3. Act as Technical coordinator for CMO process technology proficiency assessment, technology standards, and implementation of MSAT Technology Roadmaps
  4. Serve as primary contact and site owner for technical issues related to EM and represent in VMT by being a single technical voice including EM, thus supporting decision / actions
  5. Maintain and develop good understanding of the status regarding ongoing and future planned technical activities at site

Skills

Required

  • Minimum 8 years of relevant work experience
  • Demonstrated experience/expertise with various dosage forms, including experience in process science and tech transfer of Liquid & solids manufacturing technology.
  • Experience working with external manufacturing network (EM)
  • Basic knowledge of Small Molecule Supply chain (products, customers, suppliers, plants)
  • Strong communication and teamwork/networking skills with the ability to interact at different levels of the organization/sector
  • Ability to lead activities under general direction, and demonstrate a good sense of prioritization of assigned tasks & goals and handle time accordingly
  • Strong understanding and knowledge of Q&C (Quality & Compliance) and the regulatory requirements (e.g., GMP, EHSS, etc.) related to pharmaceutical manufacturing environment

Nice to have

  • Experience in specialized technology which includes Freeze dried tablets, Softgel capsules etc., new pharmaceutical manufacturing technology especially continuous manufacturing or related technology
  • Understanding and application knowledge in statistics and process excellence / investigation tools

What the JD emphasized

  • external manufacturing (EM)
  • technical oversight
  • New Product Introduction (NPI)
  • technical transfers
  • Product Life Cycle (LCM) management
  • auditing
  • GMP
  • EHSS