Senior Project Manager / Medical Devices / Engineering / Process Validation / Surrey / Contract / £60k
We have an excellent and immediate opportunity with a leading Surrey based medical technology company. They are looking to recruit a candidate who possesses extensive project management experience gained in a manufacturing industry and a background in chemical or electrical engineering. This will initially be a 6-12mth contract with the potential to extend or become permanent.
Project Brief:
Manufacture of development product with device element, support and project management of the licensing of facility (MHRA) process of the critical parameters for validation of product. Strong project management of CMC and NDA filing
Success in this role would be:
- On time manufacture of stability batches
- Significant progress on writing of NDA modules
- Initiation of Phase II portion of manufacturing process
Responsibilities:
- Provide a focus for the day to day management of the project, mobilising the team between project team meetings, building a collaborative and supportive group who makes continual progress
- Assist the team in seeing the bigger picture and how each sub project fit into and impacts all CMC activities as well as the program
- Ensure the project is managed according to agreed costs, quality and timelines
- Run risk management process, identifying and mitigating potential risks
- Monitor and report the on-going progress of the project to relevant stakeholders
- Participate in project team meetings
- Train and mentor others in the behaviours that influence and have a positive impact on the team objectives
Required Experience:
- Extensive Project Management Industry experience
- Experience in a multi discipline role with a focus on CMC, particularly in the area of manufacturing both device and drug
- Clean Room construcion decommissioning experience
- Extensive process validation in manufacturing
- Chemical or Electrical Engineering background
- Excellent planning and organising skills with the tenacity to drive projects to conclusion
- Team-orientated and flexible
- Proven ability to guide a multifaceted team
This is a highly stressful, continually changing, fast moving project and the person must work well in that environment
Salary - circa £60k per annum