Crucell is a global biotech company that focuses on the development, pro­duction and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.

Within Crucell talented, entrepreneurial people are working in a dynamic cul­ture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell.
CMO / CRO Support Specialist

Department/Project:
USP / DSP withing Process Development

The CMO Support Specialist is responsible for the close follow up of activities outsourced to a CMO / CRO to make sure Crucell gets the work packages executed in the appropriate quality, time and cost.

Job Description:
• Responsible to follow up and support of the CMO / CRO in the execution of Crucell work packages.
• Responsible to follow up and support of the CMO / CRO to assure the appropriate quality of the Crucell work packages.
• Responsible to follow up and support of the CMO / CRO to assure compliance to budget of the Crucell work packages.
• Review the documentation prepared by the CMO / CRO to execute the Crucell work packages and bring it to the required quality level.
• Being physically present at the CMO / CRO to witness /support the execution of the Crucell work packages and to guide corrective measures if required.
• Prepare in collaboration with the CMO / CRO the documentation required to support dossier submission (pre-IND / IND / BLA).
The CMO / CRO support specialist is responsible for support projects ongoing at a contract manufacturing / research organization.
The CMO / CRO support specialist is responsible for the timely execution of the Crucell work packages at the appropriate level of quality and within budget.
The CMO / CRO support specialist is responsible to support the CMO /CRO in the preparation of documentation required to support dossier submission (pre-IND / IND / BLA).

Minimum Qualifications:
Must have a minimum of at least 10 years experience in USP/DSP process development and GMP manufacturing.
Experience with regulatory authorities required.
Significant experience with QA required.
Studies in biology/biotechnology/bioprocess engineering.