Senior Scientist Proteins AD - Container Closure Integrity

About the role

The Container Closure Integrity (CCI) team is a development laboratory within the global Research & Development organization, operating in the GMP environment of Johnson & Johnson Innovative Medicine Supply Chain. It supports biologics and advanced therapy products (antibodies, cell and gene therapies, antibody-drug conjugates) across oncology, immunology and neuroscience. The company is looking for a Senior Scientist to lead projects for early- and late-phase development programs and commercial products, helping to expand laboratory capabilities and deliver compliant analytical strategies and procedures.

Key responsibilities

• Lead project coordination, development and validation of CCIT, SBIT and related assays for container closure systems and devices used in cell and gene therapy, antibody and antibody-drug conjugate programs.
• Coordinate method development, validation and transfer in line with internal guidance and health authority expectations.
• Provide timely scientific support for investigations and other high-priority requests with short turnaround times.
• Align project plans, deliverables, timelines and risks with internal and external partners, and represent the team in project meetings as a subject matter expert.
• Write technical documents such as study and validation protocols and reports, and compile, interpret and communicate analytical data.
• Propose process improvements and evaluate emerging technologies to build fit-for-purpose laboratory capabilities.

Required profile

• Master's degree with at least five years of relevant experience, or PhD with at least two years, in life sciences, materials science, analytical or pharmaceutical development.
• Experience with container closure systems (vials, prefilled syringes, cartridges, bags, needle-based or on-body delivery devices) is advantageous.
• Experience in a pharmaceutical or other GMP-regulated environment is preferred.
• Excellent written and spoken English; German is desirable.

Required skills

• Analytical development, GMP compliance and regulatory documentation.
• Preferred: CCIT at frozen conditions, residual seal force testing, head space analysis, helium leak detection, CMC, scientific writing, investigation and process improvement.