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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Johnson & Johnson Innovative Medicines is recruiting for the Advanced Therapies Manufacturing Science and Technology (MSAT) organization. The MSAT Principal Scientist leads complex, global investigations and Life‑Cycle Management projects to drive reliability, innovation, and sustainability across the Lentiviral Vector production network of the Advanced Therapies Supply Chain. This role partners with global and local teams across Operations, R&D, Quality, Regulatory Affairs, and other Supply Chain functions to ensure processes meet current and future needs.
Location: Sassenheim, The Netherlands or Raritan, NJ, USA.
Key Responsibilities
- Lead complex investigations with global cross‑functional teams.
- Collaborate closely with global and site manufacturing and support teams to ensure commercial production and supply demands are met.
- Lead Life‑Cycle Management projects that enhance manufacturing output through optimization and harmonization across Lentiviral vector production sites.
- Identify and implement new technologies; focus on reducing COGs, partner with R&D and Supply Chain groups to develop and implement strategies to improve the fit for plant and commercialise new products into the supply chain network.
- Contribute, review, and approve product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc.).
Required Qualifications
- Master’s degree in engineering or equivalent with 8–10 years of work experience. PhD preferred.
- Strong technical knowledge of ATMP and/or biotherapeutics manufacturing site unit operations (DS and/or DP) under GMP conditions.
- Demonstrated competency and experience leading complex investigations with global cross‑functional teams.
- Ability to influence and lead peers, senior management, and external partners.
Preferred Qualifications
- Experience with (lenti)viral vector products and manufacturing under BSL‑2 conditions.
- Experience with manufacturing sterile products.
- Knowledge of manufacturing site systems and procedures (SAP, event and complaint handling, change control, qualification, Process Validation, Continued Process Verification, etc.).
- Demonstrated leadership in integrating activities and information across multifunctional groups and matrix teams, coordinating and maintaining communication with stakeholders and the wider network organization.
- Project management skills; effective integration of deliverables and support execution at the manufacturing site level.
- Motivated and self‑starter able to work independently with strong problem‑solving skills.
- Good knowledge of Quality and Compliance, and regulatory requirements including Annex 1.
Other Requirements
- Excellent command of written and spoken English.
- 10–25% travel may be required, depending on project needs.
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