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]