Working as part of the External Technical Services, the ideal candidate 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.
collaborate within the organization to drive for results
input for IND, BLA and other technical documents for regulatory agency
submission in support of manufacturing process operated at CMOs.
expertise in trouble shooting activities to support manufacturing either on
site or virtually
lead process optimization initiatives and address opportunities for efficiency
and capacity improvements in all areas of manufacturing
travel may be required
·Minimum of 5 years’ experience in providing technical support to Drug Product manufacturing (facility
design, technology transfer or routine cGMP manufacturing)
knowledge of formulation and aseptic fill finish unit operations and freezing
understanding of cGMP requirements for commercial Drug Product manufacturing
technology transfers and scale-up
to work independently and to build highly effective relationships both within
and external to the company
analytical thinker with strong attention to detail
and written communication skills, including technical writing
working with CMOs would be a distinct advantage
Bachelors’ degree in Engineering (Chemical, Biochemical) or related field.
Advanced degree would be an advantage.
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