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医药 / 医疗器械 / 生命科学行业
Principle Scientist, New Product Development
Major Responsibilities:
- Lead and manage multiple product development projects in support of departmental plans by collaborating with a highly matrixed group of internal and external personnel to ensure project steering to exceed timelines and cost parameters, including project KPIs.
- Apply leading-edge science to develop, validate and support in vitro and/or analytical methods to support formulation development and provide support for product claims.
- Independently design experiments and carry out scientific work with an awareness of state-of-the-art technology.
- Develop strong, collaborative relationships with other departments/groups and fosters an environment of knowledge sharing.
- Createproject development plans to fit overall project objectives.
- Maintain precise experimental records; issue test methods, validation protocols and reports, write invention records to protect scientific discoveries, issue project status and other reports.
- Provide consultation, review and guidance to support product registration.
- Responsible for developing and maintaining timelines for 3rd-party R&D contractor’s activities consistent with the overall project plan timeline and milestones.
- Interface with internal or external manufacturing/supply team to ensure successful technology transfer of new product development projects with agreed standards on time..
Requirement:
- PhD or MS degree from one of the following education backgrounds: pharmaceutical science/technology, chemical engineering, chemistry.
- PhD with minimum 5 years or MS with minimum 10 years product development experience preferably in the Pharmaceutical/OTC drug/Consumer Healthcare industry.
- In-depth knowledge and experience of modern drug delivery technologies and modern formulation/processing technologies for different product dosage formats such as tablet, capsule, granular, gel, lotion, cream, liquid/solution are desired. Candidates with previous experience and knowledge in cGMP and China regulation, particularly on the CMC part are preferred.
- Technical expert, proven track record in formulation and process development with hands-on skills and research experience.
- Proven ability to lead and deliver projects on time and within budget.
- Excellent understanding of Drug and Food GMP’s as well as familiarity with SFDA requirements.
- Good communication and technical writing skills, excellent spoken and written English and Mandarin.
若您有意此职位,请发送个人简历到 resume@impresschina.com
If you are interested in this position, please send resume to resume@impresschina.com