Senior Principal Scientist\Director Level Scientist – Protein Characterization, Analytical Sciences

Responsibilities:

• Conduct and instruct structural characterization analysis including but not limited to intact protein mass analysis, peptide mapping/proteomics analysis, N-glycan analysis to support process development of protein therapeutics for early and late phase programs for IND/BLA filing;
• Be familiar with physiochemical (RP, HPLC, HIC, IEX, CE etc.) related method development, troubleshooting, improvement, optimization, qualification/validation and method transfer;
• Be able to draft and review technical reports and characterization report in a timely manner to meet project milestones or deadlines;
• Interact and communicate with internal colleagues and/or clients from many other functional areas to update analytical results;
• Supervise junior scientists to carry out laboratory testing, data analysis and results reporting in compliance with regulatory requirements.
• Lead trouble-shooting and technical development, especially about MS based methods.

Qualifications:

• Ph.D. in analytical chemistry with at least 4 years of industrial and research lab experiences with proven scientific and industry accomplishments for protein characterization
• Hands on experiences in different high-resolution LC-MS platforms (Q-TOF, Orbitrap etc.) and in-depth knowledge in protein characterization;
• Expertise with other analytical techniques such as CE-SDS, cIEF, HPLC are highly expected;
• Good knowledge in regulatory requirements, including instrument maintenance, document drafting, review and archiving, EHS, 5S and IP protection;
• Strong technical skills in sample preparation, experimental design and execution, results analysis, sharing, and reporting;
• Good team player willing to collaborate in a cross-functional work environment; Proactive in reporting project updates to project managers and CMC leaders;
• Excellent communication skills (both verbal and written) and interpersonal skills; Fluent in Chinese and English;
• Work experiences in pharmaceutical or biotech industries are advantageous.