CMC Project Manager

CMC Project Manager

Remote Working Flexibility

Oxford/London

Attractive salary + package

Responsibilities:

·      Works with the project teams to ensure that contractors fulfil contract requirements and complete process development or manufacturing projects as appropriate.

·      Tracks the progress of projects.

·      Disseminates and facilitates information flow/exchange among departments and between contractors.

·      Manage scope change in project execution.

·      Participates in regular internal project meetings to discuss and plan projects.

·      Participates in regular meetings with contract organisations to update progress via teleconference or site visits as appropriate.

·      Maintains records to document all relevant communications related to projects.

·      Support the maintenance of company standard quality and format of communications (e.g.letters, requests for proposals, reports, etc.) and overall harmonisation of documentation at the departmental level.

·      Monitors timelines and contracts for accuracy and follows up on any discrepancies with contractors and/or internal personnel.

·      Assists with training of team members as appropriate.

·      Supports CMC activities: tracks and maintains manufacturing documentation. Manages the transfer of data and record from contract manufacturing organisations

·      Performs other duties as required

Qualifications:

·      BSc or equivalent experience in science/technical.

·      Minimum 3 years’ experience of biologics, preferably viral vector manufacturing to GMP

·      Understanding of CMC requirements for all phases of clinical development

·      Excellent writing and communication skills in fluent English; ability to understand and communicate scientific information.

·      Proven ability to communicate in a clear and concise manner

·      Ability to work independently, cross functionally and collaboratively in a team

·      Manage and develop supply chain contractors to ensure all projects are delivered on time, within scope and to required budgets.

·      Cover all other project management requirements including logistics and detailed project plans.

If you are interested, then apply or directly via email at [email protected]