Analytical/Bio-analysis R&D Position (Senior Scientist or above)
- Lead efforts for analytical development, stability studies within ASC
- department; function as project leader role in analytical & stability projects for biologic drug products
- Plan and execute batch release, stability study for biologics of drug substances/drug products; perform stability and release analyses, but not limited to samples for drug substances /drug products used for clinical trials
- Author, review and/or approve the analytical methods, method validation reports, stability study reports, Certificate of Analysis (CoA), summaries/reports, etc.
- Ph.D. or Master Degree in analytical chemistry, pharmaceutical analysis or other directly-related science discipline with experience or training in analytical chemistry, pharmaceutical analysis or equivalent experience.
- Must have overseas study or working experience and industrial experience in Analytical R&D field.
- Must be familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines and industry trend/practice in analytical development requirements.
- Must be able to coach junior scientists or managers to accomplish performance objectives.
- Experience with late phase programs is desired.
Small Molecular Bio-analytical R&D
- BS, MS, PhD degree in a science discipline with experience or training in analytical chemistry, or equivalent experience.
- Execute and follow the policies and SOPs of BAS department and company. All work will be conducted in compliance with FDA Good Laboratory Practice regulation and OECD GLP guidelines.
- Expected to be a supervisor and train junior employees.
- Open exchange of information and project teamwork will be required in order to meet performance. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.
- Training in or experience with the requirements of FDA GLP regulation and OECD GLP guidelines is required
- Must be experienced with standard analytical techniques, particularly HPLC and LC-MS.
Large Molecular Bio-analytical R&D
- PhD with several year’s experience in relevant industrial experience.
- Solid knowledge and skills in Immunology, Biochemistry, Biology, Immunoassays, ELISA, ECL, MSD.
- Hands-on experience on immunoassay development, validation, and sample analysis.
- Skilled executive with extensive experience in leading small and large molecules bioanalysis laboratories is a must for Ex. Director level and above
- Proven ability to motivate, mentor and work efficiently, as well as with persons from other cultures, both in cross-functional and self-directed work teams
- Good communication skills in both English and Mandarin Chinese
Job Function: Research & Development
Primary Location: China – Shanghai