Manager-track GQP quality assurance for Nippon Kayaku's pharmaceuticals: data review for manufacturing sites in Japan and overseas, audits, regulatory filings and developing junior staff.
About this role
A research position in the pharmaceutical business of a manufacturer whose main drugs are anticancer agents and cancer-related prescription medicines, spanning new drugs, biosimilars and generics. The role designs injectable formulations for anticancer drugs, biosimilars and adjacent areas.
The work covers formulation and manufacturing-process studies for injectables, scale-up for commercial production, development schedule management, CTD documents for approval applications and responses to regulators' queries, and support for CMC development management. Over time it can extend to selecting development candidates and proposing formulation ideas.
Required: a university or master's degree or higher, plus all of the following for generic or biosimilar injectables: five or more years of injectable formulation design; a product designed personally from early studies to launch; scale-up and technology transfer to manufacturing; CMC-related CTD preparation and query handling; and HPLC analysis.
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