Working as part of the External Technical Services, the manager will be responsible for the technical aspects of Drug Product (Fill Finish) manufacturing at Contract Manufacturing Organisation (CMO) sites.
· Act as subject matter expert in for Drug product processes, including technology transfer, process evaluation, problem solving and investigation.
· Work through collaborate within the organization to drive for results
· Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
· Provide expertise in trouble shooting activities to support manufacturing either on site or virtually
· Identify and lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
· international travel may be required
· Minimum of five years' experience in providing technical support to Drug Product manufacturing (facility design, technology transfer or routine cGMP manufacturing)
· Comprehensive knowledge of formulation and aseptic fill finish unit operations and freezing drying
· Good understanding of cGMP requirements for commercial Drug Product manufacturing
· Experience of technology transfers and scale-up
· Proven ability to work independently and to build highly effective relationships both within and external to the company
· Organised analytical thinker with strong attention to detail
· Excellent oral and written communication skills, including technical writing
· Experience of working with CMOs would be a distinct advantage
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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