人材紹介Michael Page Japan
|企業名||US Pharmaceutical Company|
メディカル/医薬/バイオ/素材/食品 - 製品開発
* Line manage employees in pharmaceutical R&D production plant at US pharmaceutical company.
* Work closely with Japan R&D Head and Global R&D to design and implement formulation development strategies, scale-up preparations and CMC activities.
* Draw up formulation development strategies for pharmaceutical.
* Implement (formulation development) operations based on the strategies.
* Communicate and cooperate with Global sites (evaluate and present opinions on overseas research and development operations).
* Assist applications for products developed in overseas and launch the products locally.
* Scale-up and preparation of documents for technical transfer.
* Achieve objectives corroboratively with senior director.
* Strong experience in formulation development at pharmaceutical companies. (Hands-on skill is required).
* Formulation development and manufacturing process establishment particularly for oral solid dose.
* Experience in working closely with overseas units.
* Experience in people management and people and organisation development.
* Experience in evaluation and implementation of stability and dissolution testing.
* Experience in evaluation and implementation of physicochemical test conditions (assay, purity tests, identification, and other tests using HPLC or other devices, preparation of study protocols, confirmation of data, and other related operations).
* Experience in transfer of manufacturing operations.
* Operations concerning preparation and application of DMF (Drug Master File) for overseas raw materials for drug production.
* Managerial experience including team-building and human resources development.
* Strong leadership, communication, creative and analytical skills.
* Mentor and coach team members as the team leader, reviewing their progress and field reports.
* Strong communication and presentation skills; able to interface at all stakeholder levels.
* Thinking outside of box.
* Manage production plant at global US pharmaceutical company.
* Contribute to drug development across a number of therapeutic areas.
Page Group Japan is acting as an Employment Agency in relation to this vacancy.
|* US Pharmaceutical Company specialising in development of drugs for following the areas oncology, infectious diseases, pain management, cardiovascular areas.|