Project Manager, Technology Transfer

Ref: EM/187324/2_15264867
Sector: Production & operations
Region: Southern Ireland
Job Type: Permanent
Start Date: 16/05/2018
End Date: 23/05/2018

Project Manager, Technology Transfer

The Project Manager will work with the Manufacturing Sciences and Technology (MSAT) group in Rensselaer, New York to transfer manufacturing processes to Raheen and partner facilities. The position will also focus on ensuring site to site consistency after the processes are successfully transferred. The Project Manager will also provide floor support during operations of manufacturing campaigns, review process data to ensure operational consistency and provide support for investigations.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Work with all relevant departments to coordinate technology transfer activities.
* Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities.
* Review technology transfer protocols and reports, manage document exchange (which includes documents such as SOPs, SPECs, validation, raw material and instrument qualification documents, batch records, etc.).
* Provide process transfer support to external facilities, including generation of process descriptions and facility fit comparisons.
* Provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the manufacturing organization.

Education and Experience
* BS in Biological Sciences or Engineering with 7+ years of relevant experience in a cGMP environment; relevant Masters or PhD may be considered in lieu of industry experience.
* A qualification in Project Management is desirable.
* Solid knowledge of cGMP and other applicable regulations.
* Ability to facilitate meetings with cross functional teams.

If interested, contact me using:

Name: Eduard Mardaru
Tel: +41 43 508 0817 | Int Ext: 3124

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