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Scientist Drug Product Process Development

Ref: 14977596

Posted on 21 December 2021
Job Location
Leiden
Contract Type
Posting

Functieprofiel

The Process Development group within the Drug Product Development department is responsible for early-and late-stage process development activities in drug product manufacturing. The developed manufacturing processes are transferred to external GMP production facilities to produce clinical batches aswell as for scaled-up process validation/verification and commercial manufacturing.

Your activities would include:

  • Establish and maintain a trustful and professional relationship with the stakeholders from departments within the company as well as with external partners
  • Understand and provide input to define the technical content of the registration dossier, by guaranteeing availability of source documentation and data
  • Setup, report and timely execute process development, characterization and validation activities, which can be done in-house or externally
  • Lead and participate in specialized committees, to ensure continuous improvement on departmental and project level

Bedrijfsprofiel

Modis is part of the Adecco Group and is the Professional Staffing/Consulting group and we have Consultants in our team who we second to clients. Currently it employs 500 consultants in the Netherlands and 20,000 worldwide. The focus of Modis Life Sciences is mainly in the direction of QA, QC, PV, RA, R&D and process profiles within an organization in the field of Biotech, Pharmaceutical industry and Food. We have Consultants working at EMA, Janssen, Sanquin, Astellas, Unilever, Corbion, MSD, Aspen and many more!

We have an exciting new job opportunity as a Scientist Drug Product Process Development at our pharmaceutical client at their location in Leiden.

Functie-eisen

You are perfectfor the job when you have roughly the following profile:
  • Preferably a Ph.D. degree or MSc degree in biopharmaceutical sciences, biotechnology or related fields•A proven experience in late-stage pharmaceutical development and GMP drug product manufacturing, including technology transfers
  • Experience with two or more of the following is a pre: life cycle process validation; regulatory submission writing; technology transfer; process improvements
  • Project management skills
  • The highly dynamic environment requires you to have a strong work ethic, be resilient to change and be creative

Information

If you wish to receive more information first, please contact the Modis Life Science team on lifesciences@modis.com.

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