• 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
• M.S. or Ph.D. Degree in Pharmacy, Chemistry or Polymer with background in pharmaceutical development and analysis.
• 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
Working Conditions工 :
• 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)