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. 

CMC Leader

Job Description:
· Responsible for the management of the interface between the Program Directors and PD in order to translate program needs into PD work packages.
· Responsible for the preparation of a Program Development Plan for PD after transfer of a program through the program directors to PD.
· Responsible for the elaboration of an annual Process Development roadmap which ensures an optimal balance between capacity and resources availability and the program needs..
· Responsible Point of Contact (POC) of PD to all interfaces regarding program related issues
· Responsible to assure delivery all the required information through PD for a successful and timely registration with all concerned authorities (EMEA/FDA).
· Responsible to propose and manage the necessary budget based on the roadmap of Process Development for the individual programs.
· Manage employees in PD through the programs in such a way that they are motivated to contribute in reaching the PD objectives.
Strong interaction with the global head Crucell PD to achieve the implementation of the PD Value Stream including the new set up to PD as well as the execution of the annual Process Development roadmap.

Strong interaction with its reports (CMC-Leaders) to align the activities required to advance the various programs in a coordinated way.

Strong interaction with the directors USP/DSP, Assay, and Pilot Plant departments to align activities of the departments with the program needs.

Strong interaction with the QA and RA group to align the deliverables (documentation) of the programs with the guidelines.

Minimum Qualifications:
Studies in cell biology/biotechnology/bioprocess engineering or significant project management experience. Minimum of 5 years experience in a biotech GMP manufacturing plant.
Must have a minimum of at least 3 years experience of leading projects and people in a multi national environment.