Technical Leader/Senior Engineer--某欧美500强医疗行业企业亚研发中心

Responsibilities/ Authorities:

 Account for bio-compatibility study for PD and HD product development programs and marketed product investigations;

 Collaborate with global teams to harmonize the biocompatibility study process and build the biocompatibility testing capability in China Design Center;

 Provide leadership for various operational tasks within laboratory including use and maintenance of modern analytical instrumentation such as GC/MS, LC/MS, HPLC, NMR, GC, FT-IR, ICP-OES, GPC and etc.

 Develop and validate trace-level analytical methods with minimal supervision;

 Conduct routine analytical testing if required;

 Coach junior scientists to conduct the testing;

 Possess good judgment and awareness to recognize and solve laboratory/data issues to assure high quality data.

 Collaborate with external partners to conduct the E/L testing and biological testing;

 Work within and across technical teams;

 Write validation protocols, validation reports, technical reports, investigations, and documents for regulatory submissions

 Maintain an accurate technical notebook

 Follow standard operating procedures and keep current on all mandatory training

 Other duties as assigned

Qualifications:

Education background:

 M.S. or Ph.D. Degree in Pharmacy, Chemistry or Polymer with background in pharmaceutical development and analysis.

Work experience:

 MS with at least 6 years, or PhD with at least 3 years of relevant experience. 

 Over three years work experience on the pharmaceutical/medical device industry, especial on the leachable and exactable study as well as biological study.

Competence and skills:

 High-level analytical problem-solving skills, utilizing and maintaining modern analytical instrumentation such as GC/MS, LC/MS, HPLC, NMR, GC, FT-IR, GPC and etc.

 Leadership of technical teams is desirable.

 Candidate must be able to work independently as well as under direction while contributing knowledge and experience to projects.

 Must be self-motivated, possess good interpersonal skills, and the ability to handle a wide variety of work assignments while meeting tight timelines.

 Chromatographic method development and validation experience

 Lab experience including research in GMP environment is desirable.

 Excellent communication skills, including technical writing and oral communication in both Chinese and English;

 Must be willing to conduct routine testing

 Ability to troubleshoot instrument and method issues

 Lead and/or contribute to laboratory investigations

 Computer skills (Excel, Word, PowerPoint, Minitab)

 Experience with Empower and ChemStation chromatographic data systems

 Experience and/or interest in extractables/leachables and parenteral drug product development

Others: N/A

Working Conditions :

 Working conditions are in an office, laboratory and/or manufacturing environment. 

 Occasional weekend and/or evening work may be required.

 Travel up to 10% of time may be required. (International & Domestic)