Sr Associate Scientist MSAT AT

Senior Associate Scientist MSAT Advanced Therapies

J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Associate Scientist MSAT Adv Ther to be based in Sassenheim, the Netherlands. Our site produces lentiviral vectors for CAR-T therapies and is expanding its capacity and portfolio.

The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting technology transfers, process validation, technical product ownership and key driver of sophisticated technologies to enable the best value for patients.

The Sr Associate Scientist is a member of the Manufacturing Science and Technology (MSAT) Team with the dedicated focus on

• New Product Introduction (NPI) / Life Cycle Management (LCM)
• (Process) Validation
• Process improvements
• Standards and new technology deployment

Job Duties and Responsibilities:

Contribute to LCM/New Technology Introduction for the Site

• Lead and/or support Life Cycle Management projects
• Lead and/or support introduction of new technologies and digitalization projects
• Act as Subject Matter Expert in USP and/or DSP for commercial manufacturing of lentiviral vectors
• 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 Sassenheim site Operations, Quality, global R&D departments and the (global) MSAT organization
• Capable of leading and supporting complex investigations, facilitation of risk assessments and defining appropriate corrective and preventive actions
• Defining and implementing process improvements
• Act as SME during internal and external audits and inspections
• Represent Sassenheim MSAT in global project teams.

Minimum Qualification and Requirements

• 5+ years of relevant experience and BS degree or equivalent OR 2+ years with advanced degree MS/MBA/Ph.D. or equivalent.
• Extensive knowledge of and experience in a scientific or technical core area. Building knowledge and expertise in other technical and business disciplines.
• Strong affinity with process (analytical) technology and digitalization of manufacturing
• Delivers local small projects, regional project work streams or departmental programs successfully under supervision. Selects applicable engineering/scientific tactics.
• Proposes project and/or program goals and tactics. Assists in defining objectives to achieve targets on a team and/or individual level.
• Demonstrates the ability to communicate in business and technical terms with equal effectiveness.
• Skills in communication, planning, documentation practices, risk management, root cause problem solving and knowledge management.
• Works independently within scope, receiving general guidance.

Hybrid Work 

Location: Sassenheim, NL