Function
Discovery & Pre-Clinical/Clinical Development
Sub function
Biotherapeutics R&D
Category
Senior Principal Scientist, Biotherapeutics R&D (ST8)
Location
Leiden / Netherlands
Date posted
Jun 21 2025
Requisition number
R-020291
Work pattern
Fully Onsite
Description
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. Learn more at https://www.jnj.com

EDUCATION:

• PhD in Biochemistry, Immunology, Virology, Biological Science, or a related field with 6 years of biopharmaceutical development experience OR Master’s degree with 8 years of experience in biopharmaceutical development is required.

• Representing analytical development to provide strategic and scientific guidance to CMC project teams for all analytical topics including method development, control strategy and regulatory filings supporting FIH through commercial licensure.
• Leading the development and execution of analytical strategy, including shaping the strategy to meet global health authority expectations.
• Leading the analytical review of each program at governance meetings with support from subject matter experts.
• Ensuring the submission of complete, consistent, comprehensive, high-quality dossiers.
• Effectively communicating project status, resources and issues to senior management.
• Partnering with Business integrator to ensure accurate and forecasting aligned to CMC deliverables.
• Representing analytical at health authority inspections and meetings with health authorities.
• Project risk management, including creation of the risk register, developing appropriate risk mitigation strategies and heightened concerns.
• Interacting and influencing various internal and external partners such as Commercial Manufacturing, Regulatory, Quality, Discovery, external partners, and health authorities.
• Additional responsibilities include method transfers to commercial sites, analytical control strategy, justification of specifications, and criticality analysis.