MSAT - Senior Associate Scientist / Scientist

Job Description:

Janssen Biologics B.V., a member of the Johnson & Johnson Family of Companies is recruiting for a Manufacturing Science and Technology Sr Associate Scientist/Scientist to be based in Leiden, the Netherlands.

Leiden site Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics and vaccines in Leiden. We are responsible for Validation and Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes!

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. 

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

1. New Product Introduction (NPI) / Life Cycle Management (LCM)
2. (Process) Validation
3. Process improvements
4. Standards and new technology deployment 

Essential 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 pharmaceutical proteins and vaccines
• Define (process) validation
• 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
• Capable of leading and supporting complex investigations, facilitation of risk assessments
• Act as SME during internal and external audits and inspections
• Represent Leiden MSAT in global project

Minimum Qualification and Requirements

• 7+ years of relevant experience and BS degree or equivalent OR 4+ years with advanced degree MS/MBA/Ph.D. or
• Excellent knowledge of and experience in scientific or technical core area. Overall knowledge of multiple technical and business
• Delivers local as well as regional small projects, global project work streams or departmental programs successfully under limited supervision. Selects applicable engineering/scientific tactics. Manages multiple moderate size projects. Works effectively as part of a
• Coaching and training others
• Supports in defining department, project and/or program goals and tactics. Defines objectives to achieve targets on a team and/or individual level.
• Troubleshoots more complex problems and suggests effective
• Effectively communicates with business partners to understand and explain business and technical
• Functions independently with limited work
• Provides direct input to budget and resource

Stakeholders: Lab, Production, global stakeholders, global Technical Owner
Tools: Trackwise experience would be a plus, or any other quality reporting system
Chemistry/Pharma background
English is sufficient, Dutch is a plus
Pharma/ Medical background desirable
2 days per week onsite

For more information and to apply, please send me your CV + Cover letter to: j.vanbaalen(@)progressive-nl.com