MSAT Advanced Therapies Specialist (Contract, Hybrid)

Johnson & Johnson; Sassenheim; Hybrid; EUR 55,000 - 96,000; Full time

Job summary

Johnson & Johnson in Sassenheim is seeking a Scientific Contractor, MSAT Advanced Therapies, to lead and support life cycle management, technology transfer and implementation projects. The SME will focus on fill and finish and sterile manufacturing for commercial lentiviral vectors.

You will collaborate with Operations, Quality and global MSAT, define validation strategies, write protocols, and drive process improvements.

Qualifications

• 5+ years of relevant experience and BS degree or equivalent, or 2+ years with MS/MBA/PhD.
• Extensive knowledge in a scientific/technical core area and cross-disciplinary expertise.
• Strong affinity with process technology and digitalization of manufacturing.
• Delivers local small projects or regional work streams under supervision.
• Defines objectives and tactics to achieve targets in teams or individually.
• Fluent English, strong communication, planning, and risk management skills.

Responsibilities

• Contribute to LCM for the Site.
• Act as Subject Matter Expert in USP, and fill and finish for commercial manufacturing of lentiviral vectors.
• Capable of leading and supporting investigations, facilitating risk assessments, and defining CAPAs.
• Lead and/or support Life Cycle Management projects.
• Define process validation strategies.
• Write and review validation protocols and reports.
• Ensure validation studies meet site standards and J&J guidelines.
• Integrate global standards into local production processes.
• Interface between Sassenheim Operations, Quality, global R&D, and MSAT.

Skills

Communication

Planning

Documentation practices

Risk management

Root cause analysis

Knowledge management

Independent worker

Education

BSc in Biochemistry/Biotechnology/Chemical Engineering

MSc/PhD considered a plus

Job description

Johnson & Johnson in Sassenheim is seeking a Scientific Contractor, MSAT Advanced Therapies, to lead and support life cycle management, technology transfer and implementation projects. The SME will focus on fill and finish and sterile manufacturing for commercial lentiviral vectors.

You will collaborate with Operations, Quality and global MSAT, define validation strategies, write protocols, and drive process improvements.