Description
A Global Pharmaceutical Organisation is currently looking to expand their Global Engineering Services division by means of an experienced Technical Scientist/Scientific Project Manager.The responsibilities of the Scientific Project Manager/Industrial Scientist are as follows:
* Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training with donating site personnel.
* Participate in Gap Analyses and Risk Assessments to support the tech transfers whilst writing and maintaining the Tech Transfer Plan and Tech Transfer Documents.
* Liaise with 3rd party engineering consultants to ensure the project requirements are accurately followed and assist in the raising and execution of change controls for Technical Services.
* Provide technical training on process and technology areas as required by the project.
* Support Compliance Inspections and enquiries from Regulatory Agencies.
To fulfil these requirements for the role of Scientific Project Manager/Industrial Scientist you must have the following skills/experience:
* A minimum of 5 Years cGMP industrial experience, ideally covering Operations, Engineering, Projects and Validation within chemical process manufacturing.
* Experience with technology transfer and project engineering preferred.
* Experience of FDA and EU licensing and inspection.
* A minimum qualification of a B. Sc. Degree in Industrial Chemistry, Chemistry or equivalent. Higher Degree preferred.
The successful Scientific Project Manager/Industrial Scientist will receive a competitive rate and have the chance to work in a very reputable Global organisation within the pharmaceutical industry during a very exciting period of projects. The job may require a significant amount of travel and/or include a requirement to second to the process donor site for training and knowledge capture purposes.