CMC Project Manager

CMC Project Manager

Job Title: CMC Project Manager
Contract Type: Permanent
Location: Oxfordshire
Salary: £55000. - £70000 per annum
Reference: HQ00054977_1491561072
Contact Name: Richard Williamson
Contact Email:
Job Published: April 07, 2017 11:31

Job Description

Do you want to work for an innovative Biotech as a CMC Project Manager on a permanent basis, in the beatuciful county of Oxfordshire, well, this just might be the role for you.

You will take responsibility for the delivery of project outcomes through key development milestones with emphasis on CMC (Chemistry, Manufacturing and Control) and supply chain related project activities and outcomes.

Key responsibilities include but are not limited to:

  • Direct, plan, manage and drive implementation for CMC projects from candidate selection through key milestones. Direct cross-functional matrix project teams comprising of internal and external members, in setting and agreeing roles and responsibilities.
  • Develop update and manage project plans timelines to achieve project objectives in line with corporate needs.
  • Manage project risks and issues; and capture any scope changes to the project in contract amendments.
  • Interface, influence and communicate with key stakeholders and governance committees to ensure project visibility and timely decisions.
  • Chair project team meetings - ensure the conduct of efficient team meetings - maintain action lists, risk logs etc., circulate agendas / minutes, perform risk management, contingency planning and scenario modelling activities as required.
  • Ensure learning, transfer and utilisation of project management and drug development best practices across projects.
  • Provide accurate and complete project information, including regular updates as required.
  • Ensure that appropriate members of the team and /or external experts scientifically review all deliverables required for product development.
  • Manage the timely preparation of high quality internal / external documentation used for project reviews and / or regulatory interactions.
  • Management of the label creation and approval process internally and with the label manufacturer, including responsibility for the creation of label artwork and language translations, where required.
  • Liaise with Project Leaders and Clinical teams to maintain stocks of labelled and packaged IMP, pharmacy supplies ready for use in clinic.
  • Manage and arrange shipments of IMP and pharmacy supplies to and from distribution centres and clinical sites.
  • Recording delivery process and shipments to enable reconciliation of inventory.

For more information, please contact apply to this advert or call Richard Williamson on 02033273072