We are delighted to present you this exciting role wiht a global leader in the Animal Health industry. Our client have an excellent reputation in the industry and they are looking for a Technical Services & Manufacturing Science Representative to join their team in Japan.
As TS/MS Representative you will be responsible for partnering with and coordinating activities with Contract Manufacturers (CM) in the Asia-Pacific region, specifically Japan and Taiwan.
The job scope includes new product introductions, technology transfers, validations, process improvements, and trouble-shooting of manufacturing problems. Scope of responsibility includes both Active Pharmaceutical Ingredient and final dosage form contract manufacturing. Dosage form regulatory implications are APAC-specific and the API regulatory implications are global.
- Provide technical oversight for manufacturing processes
- Manage product periodic reviews, plan validations, and provide stewardship
- Collaborate with EEM colleagues from the Business Unit and Quality, as the technical representative for the Contract Manufacturing (CM) governance process
- Ensure that CMs comply with all applicable GMP and HSE standards.
- Coordinate change controls and deviation resolutions at CMs
- Provide professional project management for the companies interest in CM projects
As TS/MS Representative will act as a primary contact for technical matters between EEM-APAC, Contract Manufacturers, EEM API, and the business' corporate operations.
- University Degree in Process Engineering, Chemical Engineering, Chemistry, Biology, or Physical Science
- Previous experience in a regulated manufacturing environment, preferably in a manufacturing or technical services role. Experience working with processes at a shop-floor level is desired. Preferred candidates have demonstrated experience partnering with 3rd party manufacturers.
- Experience in an applied technical area (Pharmaceutical Operations, Product Formulation, Process Development, Laboratory Operations, or Applied Quality) is desirable.
- Previous experience in final dosage form products and their manufacturing processes (i.e. liquids, suspensions, tablets, powders) or in Active Pharmaceutical Ingredient processes is desirable.
- Candidates with experience in regulated industries outside of animal health/human pharmaceuticals (such as food processing) will still receive strong consideration.
A highly ambitious package will be negotiated with the right person, commensurate with skills and experience. Our client is an equal opportunity employer and values diversity at their organisation.
This opportunity provides the successful candidate with the platform to grow within the organisation, both locally, regionally and globally.
Please note only applicants who meet the relevant criteria will be contacted.
For a confidential discussion contact Alicia Keenan on email@example.com +61 416 890 346 or apply online at www.aicila.com referencing VRN0908.