Experience

BiosanaPharma

• Netherlands
• Biotechnology Research
• 1 - 100 Employee

• Process Validation Specialist

  • Nov 2022 - Present

  • Moved from supplier to customer to continue working on the same project. • Organizing, coordinating and writing the process risk assessments to identify gaps and getting the process ready for filing. • Introducing process improvements for the continuous manufacturing process for USP/DSP and in line analytics. • Recipe programming using different platforms for automated continuous manufacturing. • Creating process characterization and validation strategy for the post Clinical Trial Material stage. • Extensive process support and troubleshooting as SME for USP/DSP during the Clinical Trial Material runs at the CMO. • Writing and spearheading deviations, their impact assessments and implementations of corrective actions as the subject matter expert to aid the CMO. • GMP audit support. • Writing reports and GMP documentation, making the documents BLA and IND ready from first draft. Show less



HALIX

• Netherlands
• Biotechnology Research
• 1 - 100 Employee

• Lead Engineer USP/DSP

  • Jun 2022 - Nov 2022

  • Lead engineer for upstream and downstream processes within the production department • Coordinating the tech transfer from R&D to manufacturing. • Working closely together with the customer to make their process fit to plant and within agreed timelines • Subject matter expert on process, equipment, facility and project organization. • Coordinating in-house resources to fit with customer process demand with different stakeholders • Setting up and implementing a new production resources planning tool • Organize the additions of New GMP process material and component to the supply chain system • Writing and spearheading deviations, their impact assessments and implementations of corrective actions. • Being the point of customer contact within the department • Training employees in processes (LEAN) and new organizational structures to streamline the operation Show less



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Associate Scientist, Downstream project lead

  • Oct 2020 - Jun 2022

  • Downstream (DSP) lead for one of the main vaccine projects for clinical trials and PPQ • Responsible for campaign summary reports, tech transfer documentation, process validation and process characterization protocols and experimental designs. • Process risk coordination and point of contact as process expert when issues occur. • Key organizer of sample coordination between all departments and the project. • Study director of scale down model studies (Chromatography and Bioreactor) of the GMP campaigns. • Coordinating resources with different process and project shareholders to meet tight deadlines. • Driving force behind implementing new lab scale high throughput purification methods by means of automation. • Implementing new high throughput cell culture clarification methods in the pilot plant in preparation for process intensification. • Technical expert for assessing quality deviations during the process. • Core member of the Leiden site sustainability team that is starting a bottom up sustainability drive throughout the site Show less



AGC Biologics

• United States
• Biotechnology Research
• 700 & Above Employee

• • Mar 2019 - Jan 2020

  • Assigned to AGC Biologics (Seattle) on a secondment to set-up the new R&D Center dedicated to developing a new therapeutic platform for the company to leapfrog our competitors given my prior experience in facility set-up.• Combined different cell culture technologies to create a mammalian cell culture platform capable of reaching higher than industry standard titres while reducing traditional product development time by 40%.• Responsible for selecting and implementing key capital equipment and facility remodelling.• Played an advisory role on the remodelling of the GMP microbial facility.• Medium development and optimization to support the new platform process.• Setting up a capacity for a high concentration cell banking.• Contributed to the capture of our development work in new IP for the company under our team and individual names (pending).• Setting up a Lean and automated process flow to run cell culture processes with less operator resources.• Designed the first concentrated fed-batch process of the R&D center and yielded more than 50 million viable cells in a first run. Laying the foundation for the new platform based on those parameters.• Hosting and facilitating tours for our international guests and investors.• Guiding and training of the summer interns and teaching them what it takes to be a scientist at AGC Biologics. Show less

• • Jan 2017 - Mar 2019

  • Prepared and updated procedures to help increase efficiency and higher bioreactor/experiment turnover rate.• Acted as the key driving force of updating and modernizing the microbial development laboratory to get it operational for new process characterization projects• Responsible for 2 process characterization projects, one mammalian and one microbial project.• Utilised the updated culturing procedures from the mammalian development lab and adapted these to the microbial development lab, creating a basis for cross training the team on both platforms.• Generated cell banks under GMP conditions.• Implemented new small scale, high throughput technologies (AMBR-250) and used this as part of process characterization. • Created a new raw data management model to quickly compile and analyse experimental data.• Completed new and outstanding overdue deviation reports in the team.• Writing perfusion bioreactor protocols and advising on setup and parameters. Show less



Synthon

• Netherlands
• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Sep 2014 - Dec 2016

  • Played a key role as the lead technician out of a team of 7 in setting up the operations department and oversaw the construction of the monoclonal antibody pilot facility and the new cleanroom production environment to ensure they were fit for purpose.• Assisted in the successful technical transfer of our mAb process from the R&D phase into large scale GMP production and assisted in the facilitation of the second part of the clinical trial for the investigational anti-HER2 antibody-drug conjugate.• Managed the cell bank and qualification of cell bank related systems (freezing/shipping/documentation)• Successfully executed the first ever 2000L bioreactor fed batch culture in our company.• Prepared process specific technical documents for GMP (procedures, deviations, batch records, etc).• Performed the GAP analysis to identify and solve the missing aspects after tech transfer from R&D to a GMP worthy process• Prepared and executed qualification protocols for equipment and utilities.• Prepared technical documents in relation to the GMP production process for audit purposes. Show less

• • Nov 2009 - Sep 2014

  • Started in a team of 7 that grew to 20 to develop new therapeutic antibodies by means of mammalian cell culture, resulting in the first product in the company that progressed to phase 2 clinical trial.• Designed experimental plans for medium development, mixing studies, cell culture experiments, analysed data from these experiments and documented the outcomes.• Performed sample diagnostics and statistical analysis on the data collected to ensure sample quality.• Identified and recommended process improvements which were implemented in the process that is now in GMP production.• Part of the team creating a monoclonal cell line by using state of the art clone separation robotic systems for picking and creating a single clone cell line and creating cell banks.• Assisted, executed and coordinated maintenance of different laboratory equipment and facility systems.• Wrote research methods and guidelines that served as a base for future GMP documentation in the pilot plant.• Programmed and worked with robotic micro bioreactor screening system for clone screening and medium development.• Experience with a wide variety of cell culture methods (plates, (shake)flask, wave systems, bioreactors). Show less



University of Viterbo "La Tuscia"

• Italy
• Higher Education
• 200 - 300 Employee

• Reasearch intern

  • Nov 2008 - Jul 2009

  • Awarded the Leonardo Da Vinci scholarship by the European Commission to pursue a research program in Italy • Independently developed a PCR multiplex specific to the target bacteria species in asymptomatic host plants which was utilized in a field test kit. • Researched known genomes in order to find non overlapping test side for primer targets. • Prepared plant tissue culture, primer designing, RT-PCR, PCR, sequencing, DNA/RNA extractions, gell extractions and purifications as part of the experimental process. • Planned the logistics of and assisted on fieldtrips with students whilst overcoming linguistic barriers. • Offered a full-time research role for the research of Erwinia Amylovora with the university. Show less



Wageningen University & Research

• Netherlands
• Research Services
• 700 & Above Employee

• Intern

  • Jan 2008 - Jul 2008

  • Worked in the crop and weed ecology department to be part of the research about understanding the operation of Striga hermonthica and their host crop to aid small affected farmers in the sub-Saharan region increase crop yield. • Independently developed a new culturing method (Semi-hydro culture in culture plates) to attach root parasitic plants to secondary and tertiary host plant roots at different time intervals to study the importance of timing and attachment position. • Prepared and taught new practical experiments for university students in a project to familiarize sociology students with farming post production processes in preparation for their exchange to different African countries to aid in crop development work. • Small scale field work to cultivate research material. Show less