Scientific Manager, Cell & Gene Therapy Analytics

Johnson & Johnson; Leiden; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Flexible hours

Home office possibilities

Job summary

Johnson & Johnson Innovative Medicine Leiden is seeking a Scientific Manager to lead the CGTA analytics group. The role focuses on biophysical/separation tech methods for viral/vector products, with leadership of a 22-person team and collaboration across process development, quality, and regulatory authorities.

The candidate will guide method development, validation, and lifecycle management using AQbD, driving regulatory filings and patents.

Qualifications

• At least 4 years post-PhD or 8 years post-Master in analytical chemistry or life sciences.
• Experience with biophysical and separation-based technologies and method development principles for (viral) vector product development.
• Proven people leader experience.
• Preferably direct experience with clinical cell and gene therapy product development and/or method development (ICH Q2) and GMP.

Responsibilities

• Leads a complementary team developing biophysical and separation technology-based methods providing scientific mentor and has a talent for spotting people development opportunities.
• Acts as a technical analytical lead to strengthen our product development strategy, specifically lipid nanoparticle (LNP)-based products.
• Actively shares technical expertise in biophysical and separation-based technologies, such as liquid chromatography (LC), light scattering and capillary electrophoresis (CE) and drives selection and implementation of the most suitable technology.
• Strives to build the life cycle management from development using AQbD principles up to and including validation of methods for release and characterization of our products demonstrating a lean mentality for optimization.
• Enjoys working in a multidisciplinary team and has strong capabilities to collaborate with scientists across multiple teams.
• Takes ownership as author or reviewer in the preparation of presentations, reports and documents for regulatory filing and patents.

Skills

Biophysical technologies

Separation-based technologies

Liquid chromatography (LC)

Capillary electrophoresis (CE)

Light scattering

People leadership

GMP

Education

PhD degree

Master degree

Job description

Johnson & Johnson Innovative Medicine Leiden is seeking a Scientific Manager to lead the CGTA analytics group. The role focuses on biophysical/separation tech methods for viral/vector products, with leadership of a 22-person team and collaboration across process development, quality, and regulatory authorities.

The candidate will guide method development, validation, and lifecycle management using AQbD, driving regulatory filings and patents.