J&J Family of Companies Scientist Technical Operations in Leiden, Netherlands
Leiden site Technical Operations (TO) is part of the global Technical Operations organization. TO manages the technology platform strategy within Leiden as well as across the other parenteral sites. The strategy is locally executed by TO.
TO is responsible for validation and standardization of processes and equipment within the Janssen Biologics site and manages Life Cycle Management (LCM) projects and improvement projects. We accomplish this through our broad technical competency, global reach and local execution power. A job within the TO team is very dynamic and diverse. We are looking for someone who likes challenges, is collaborative and is keen on working within local as well as global project teams. And is capable to lead these teams.
As Scientist you are the primary interface between the Leiden site Operations, Quality, PDMS departments and the TO organization. You ensure integration of the global standards into local production process and/or LCM projects or local improvement projects. In support of the global TO organization you fulfill the role of ReoPro Technical Owner.
Management of LCM projects
Management of standardization projects
ReoPro Technical Owner
Support of complex investigations, facilitation of risk assessments
Execution of process validation assessment, including reporting
Subject matter expert during internal and external audits and inspections
Manager and initiator of process improvements to remain competitive. Preparing business cases.
Leading technical JJPS initiatives
Networker, change agent to implement and validate new technologies
Master degree or in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering)
Minimal 5 years of relevant work experience in the (bio-) pharmaceutical industry.
Good knowledge of EHSS and GMP requirements, high quality norm
Good large molecule API Process and process validation knowledge
Strong Analytical, expertise in leading investigations
Influencing skills, excellent stakeholder management within a high complex matrix parenteral organization
Customer focused and Innovative
Excellent verbal as well as writing communication skills in English and Dutch.
Result oriented and organizational skills
Certified as FPX project lead and/or as Green or Black Belt is a plus
Modelling experience is a plus
Janssen Biologics (7266)