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Drug Manager Product, External Technical Services

Quality & Laboratory
Dublin
Deirdre Duboy
Temporary
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Job Reference: JO-2006-65243_1592310694

Summary:

Position Summary


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.


Principal Responsibilities


· 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



Qualifications


· Minimum of five years' experience in providing technical support to Drug Product manufacturing (facility design, technology transfer or routine cGMP manufacturing)



  • Minimum Bachelors' degree in Engineering (Chemical, Biochemical) or related field. Advanced degree would be an advantage


· 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




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Deirdre Duboy
Deirdre Duboy
Talent Consultant
Quality & Laboratory
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