Experience

Janssen Vaccines & Prevention B.V.

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Manufacturing Operations Specialist/Engineer

  • Oct 2021 - Present

• Process Engineer

  • May 2010 - Oct 2021

  As a process engineer I'm involved in the tox and Phase 1-3 development of new vaccines and monoclonal antibodies for therapeutic treatments. Besides production support in both up and downstream I'm leading the Lean initiatives within my department. I implemented visual boards per team for document review. Implemented several Kanban systems (supermarket model) for all materials and assemblies in the department. Mapped out current and future state value streams. I've an ongoing Black Belt lean to double the plant capacity/utilization.



Centocor

• Biotechnology Research
• 400 - 500 Employee

• Associate Scientist

  • Oct 2005 - Mar 2010

  BioPD Purification as Drug Substance Technical Support Associate Scientist (32 hours/week). In BioPD daily life activities: - Technology transfer of new MAB Centocor Malvern (U.S.) to Centocor Leiden (NL) and Centocor Leiden (NL) to Centocor Cork (IRL) - 2nd line support of production Leiden (Remicade / Reopro / Stelara / Simponi) - Develop and execute and supervision of experiments (chromatography / ultra filtration / virus filtration) including internship supervision. - Process validation and characterization - Reporting of Clinical campaigns - Initiating improvement proposals, using various techniques of Process Excellence (DOE / Gage R & R / DMAIIC).



Centocor

• Biotechnology Research
• 400 - 500 Employee

• Sr. Technician

  • Sep 2001 - Oct 2004

  I was asked and accepted to participate in a large production extention project with the BTO Support Group as Senior DSP Technician. In DSP Support my work was from project support and ad hoc support department.In DSP Support daily life activities:- Selecting and implementing new equipment.- Represent DSP in small and large projects, including CIP plant modifications and establish new manu-facturing facility- Support the BTO Documentation Division:o Describing change proposal including substantiation.o Adjust production documentation (Batch Records) and SOPs.- Chromatography columns maintenance and column packing.- Support and implement process and equipment cleaning validations.- Maintaining contacts with key stakeholders.

• GMP shift technician

  • Sep 1997 - Sep 2001

  I started my career as Biotech Operations Downstream Processing (BTO DSP) 24-employee as GMP Shift Technician. I hold the position of backup team leader (lead process). In BTO DSP daily life activities:- Conduct Shift Transfer- Allocation of responsibilities within the team- Execution of monoclonal antibody (MAB) purification using batch records, SOPs and logs (GMP)- Monitor the progress of MAB purification process- Communication with different departments on progress- Training of operators- Initiating and escalating deviations- Initiating and implementing improvement proposals



Mogen

• Student

  • 1996 - 1997

  Isolation and purification of the Trealase enzyme in potatoes using several purification technics and enzymatic reactions. Isolation and purification of the Trealase enzyme in potatoes using several purification technics and enzymatic reactions.