Process Lead Downstream Processing (DSP)

Today’s MSD is working to help the world be well. Through their prescription medicines, vaccines, biological therapies, and consumer care and animal health products and services, they work in more than 140 countries to deliver innovative health solutions to patients and animals. MSD is the name used by Merck outside the US and Canada.
MSD is the largest pharmaceutical company in the Netherlands. R&D pilot plant manufacturing facilities are located in the US, Ireland and the Netherlands.

Department
The Center of Excellence Biotech Technical Operations gives technical support, process support - troubleshooting and continuous improvement - to the local Biotech upstream and downstream Integrated Process Teams (manufacturing), is involved by process fit / introduction of new processes in the production facilities and cooperates with other technical groups in the global network.

DSP
The IPT (Integrated Process Team) Down Stream Processing Biotech (101FTE's) is responsible for the purification of commercial products as well as clinical materials. They are manufactured in modern state of the art facilities under Good Manufacturing Practice (GMP). This year a new part of the facility will be started-up (Large Scale Down Stream processing) where Merck's new Monoclonal Antibodies will be purified on large scale.

• Management of a team of 10+ (scientists/analists/specialists).
• Primary source for overall Downstream Processing (DSP) process related know-how.
• Troubleshooting and (long term) process improvement projects and coordination of current production processes.
• Leads dedicated teams to ensure successful process transfer, clinical supply manufacturing, process qualification, regulatory submission and launch.
• Responsible for cleaning verification / validation strategy, protocol and technical reports.
• Writes Master Production Document and reviews Master Batch records, recipes and process related documentation.
• Make problems visible & strive for Continuous Improvement.

• MSc/PhD in life sciences (Biotechnology or related) or comparable level through experience.
• Extensive experience in biologics manufacturing and/or managing biotechnological/ biopharmaceutical (development) projects.
• Proven strong scientific, project & people management skills.
• Strong communicator and ability to build bridges between groups and organizations. Ability to create a team spirit.
• Knowledge of GMP guidelines.
• Willingness to certify for or possessing Green Belt or Black belt degree.
• Passion for Lean and Continuous Improvement.

Marije Hoogendoorn, Research Consultant
T: +31 (0) 6 23 13 51 18
E: hoogendoorn@themagroup.nl

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