CMC Project Director

Hobson Prior are in search for a motivated CMC Project Director to be responsible for leading the CMC and supply aspects of one or more of our client's clinical programmes. This is a permanent position based in Stevenage.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Accountable to lead CMC matrix teams supporting programme teams.
• To provide strategic leadership of the CMC elements of the project and contribute to overall programme strategy as a member of the core project team.
• Recognise and monitor CMC risks, ensuring appropriate documentation and communication of status.
• Accountable to maintain oversight of significant CMO relationships including budgetary aspects.
• You will ensure effective project management of CMC aspects of the project (including use of appropriate project management tools).
• To utilise technical and strategic expertise to ensure appropriate technical direction and effective decision making, and delivery within the CMC teams.
• Co-operate with the regulatory function to develop the project CMC regulatory strategy and perform technical review of CMC regulatory documents.
• Lead preparations for the CMC elements of the BLA/MAA, ensuring all necessary technical aspects of the registration file are delivered.
• Be the 'CMC voice' of the project at relevant internal governance meetings and relevant external meetings such as regulatory agency meetings with the trust and confidence of senior management.
• Lead adhoc CMC strategic initiatives as required.
• Coach/mentor other CMC leaders in the organisation.

Key Skills:

• Strong oral and written communication and interpersonal skills.
• Ability to lead effectively within a multi-disciplinary, multi-national, virtual team environment.
• Effective project management skills and familiarity with PM tools.
• Ability to deliver to tight timelines and adapt to changes in strategic direction.

Requirements:

• Scientific background and educated at least to degree level or equivalent in a scientific discipline, typically to post-graduate level.
• At-least 10 years' experience in CMC development/manufacturing.
• At least 5 years' experience in leading cross functional teams.
• Substantial late stage experience of biologics/advance therapy development including preparation for registration/launch.
• Substantial experience of authoring/reviewing CMC regulatory documents and appreciation of requirements for biologics registration; experience of participating in regulatory meetings.
• Demonstrable experience of developing CMC strategy and driving strategic decisions.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.