Scientific Contractor, MSAT Advanced Therapies – QC

Johnson & Johnson; Sassenheim; On-site; EUR 76,000 - 124,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leiden is seeking a Scientific Contractor to own quality records within the MSAT Advanced Therapies team, acting as a Subject Matter Expert in USP/DSP for commercial manufacturing of pharmaceutical proteins and vaccines.

You will contribute to life cycle management, technology transfer, and digitalization projects, while defining validation strategies and ensuring adherence to Johnson & Johnson guidelines and site standards.

Qualifications

• 2+ years of relevant experience and BS degree or equivalent OR advanced degree MS/MBA/Ph.D. or equivalent.
• Knowledge of quality management systems.
• Fluent in written and spoken English.

Responsibilities

• Contribute to LCM/New Technology Introduction for the Site.
• Capable of supporting complex investigations and risk assessments.
• Support introduction of new technologies and digitalization projects.
• Act as Subject Matter Expert in USP and/or DSP for commercial manufacturing of pharmaceutical proteins and vaccines.
• Define (process) validation strategies.
• Write and review (process) validation protocols and reports.
• Responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines and meet the quality requirements.
• Ensure integration of the global standards into local production processes.
• Act as primary interface between the Leiden site Operations, Quality, BTDS departments and the MSAT organization.
• Defining and implementing process improvements.

Skills

Quality management

English fluency

Communication

Education

BS in Biochemistry/Biotechnology/Chemical Engineering or related

MS/MBA/PhD or equivalent (advantage)

Job description

Johnson & Johnson Innovative Medicine in Leiden is seeking a Scientific Contractor to own quality records within the MSAT Advanced Therapies team, acting as a Subject Matter Expert in USP/DSP for commercial manufacturing of pharmaceutical proteins and vaccines.

You will contribute to life cycle management, technology transfer, and digitalization projects, while defining validation strategies and ensuring adherence to Johnson & Johnson guidelines and site standards.