We have a vacancy for a (Sr Associate) Scientist TechTransfer / Life Cycle Management (LCM) to work at Johnson & Johnson Innovative Medicine in Leiden (the Netherlands).
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We are seeking a talented Scientist to join the Manufacturing Science and Technology (MSAT) team at our Leiden site. MSAT is at the forefront of managing process technology strategies for biotherapeutics and vaccine production. Their responsibilities include equipment validation, standardization for new product introductions, and the life cycle management (LCM) of commercial production processes.
The ideal candidate will understand the company and divisional goals and recognize how their performance contributes to achieving these objectives.
As part of the MSAT team, the (Sr Associate) Scientist will focus on:
1. New Product Introduction (NPI) and Life Cycle Management (LCM)
2. (Process) Validation
3. Process Improvements
4. Standardization and Deployment of New Technologies
Key Responsibilities
- Contribute to Life Cycle Management (LCM) and the introduction of new technologies at the Leiden site.
- Lead and/or support LCM and digital transformation projects.
- Act as a Subject Matter Expert (SME) in upstream (USP) and/or downstream (DSP) processes for commercial pharmaceutical protein and vaccine manufacturing.
- Define and execute (process) validation strategies, including writing and reviewing validation protocols and reports.
- Ensure validation studies comply with site standards, Johnson & Johnson guidelines, and quality requirements.
- Integrate global standards into local production processes effectively.
- Serve as the primary liaison between Leiden Operations, Quality, BTDS, and the MSAT organization.
- Lead or support complex investigations and facilitate risk assessments.
- Represent Leiden MSAT during internal and external audits and inspections.
- Participate in global project teams as an MSAT representative.