Scientist Drug Product Process Development
For one of my renowned Biotech clients in Leiden I am looking for a Scientist for the Process Development group within the Drug Product Development department. Would you like to be part of our team to contribute to this groundbreaking development and bring life threatening diseases to a halt?
- Working in an outstanding team to develop fill/finish processes and technology transfer of innovative vaccines.
- 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.
- 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 as well as for scaled-up process validation/verification and commercial manufacturing.
- Preferably a Ph.D. degree or MSc degree in biopharmaceutical sciences, biotechnology, or related fields.
- Requires experience with regulatory submission writing and/or technology transfer for drug product (vaccines)
- A proven experience in late-stage pharmaceutical development and GMP drug product manufacturing.
- Experience with life cycle process validation and/or process improvements is a pre.
- You work with passion and demonstrate strong leadership and initiative
- You can analyze problems on a high level
- You have a critical demeanor and an amazing scientific and quality attitude
- Our highly dynamic environment requires you to have a strong work ethic, be resilient to change and be creative.
- Good communication and interpersonal skills with stakeholders
- Project management skills
- Excellent written and oral communication skills in English
- 1th of March 2021 (flexible)
- 1 year contract (chance of extension)
If you’re interested in the above description, please apply with your CV by clicking on the ‘apply’ button below. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at email@example.com