We are seeking to recruit a Scientist/Sr. Scientist to join Physicochemical Development Department. The successful candidate will be responsible for analytical method development and structure characterization of biopharmaceutical products, such as enzymes, peptides, monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, fusion proteins. She / he will lead the development and improvement of analytical methods, which include, but are not limited to HPLC/UPLC and/or CE. The candidate is expected to design, execute and document laboratory studies for supporting process development, clinical trial and product license application.
Primary Responsibilities:
o Develop and optimize analytical methods such as SEC, IEX, HIC, HILIC, RP, CE-SDS, cIEF, and other protein analytical methods to support structural elucidation and physicochemical characterization of biopharmaceutical products.
o Serve as technical resource for analytical method development, transfer, data interpretation, method troubleshooting and improvements.
o Conduct studies in-house to increase the understanding of candidate molecules, works closely with cell line, cell culture, purification, conjugation, formulation and device development groups and support the process development activities.
o Prepare and review SOPs, protocols, and reports related to product release, stability study, method validation, etc.
o Conduct developability study and collaborate with research colleagues on transition of new molecules to CMC development.
o Author and review technical reports and CMC sections related to analytical procedures, method validation, specifications, reference standard and stability in regulatory submissions.
BS/MS degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field.
o Hands-on experience in analysis of proteins, peptides and glycans with analytical methods such as SEC, RP, IEX, HIC, HILIC, CE-SDS, cIEF, CZE.
o Method development and optimization experience
o Hands-on experience in robustness evaluation of HPLC and/or CE methods
o Detail-oriented and capable of identifying and solving scientific problems.
o Ability to work independently in a fast-paced environment and drive multiple projects simultaneously.
o Strong interpersonal skills, excellent oral and written communication skills, good documentation skill.
o Good multi-tasking, time management and organizational skills are essential.
o Experience with N- and O-glycan characterization is a strong plus.
o Experience with LC-MS analysis of peptides and proteins is a plus.
