Director-late stage analytical science

SUMMARY AND KEY ACCOUNTIBILITIES:

WuXiBiologics is seeking a qualified candidate to fill director level position (depending on candidate’s experience) within its late-stage analytical science department in Wuxi city. This position is within analytical science group and will work collaboratively in cross-functional teams on a range of programs from IND through BLA to commercial stages. The candidate will work in a highly collaborative environment to utilize skills in partnership with internal and external experts.

• Support technical transfer, testing and trouble-shooting of CMC process development, including but not limited to late stage process development, process characterization, BLA-enabling product characterization et al.
• Establish and maintain Critical Quality Attributes (CQAs) in alignment with process understanding, and define the corresponding analytical control strategy (release, stability, and in-process testing) to ensure product quality and regulatory compliance
• Lead analytical contributions to regulatory filings, inspections, and post-approval lifecycle activities
• Develop and implement mass spectrometry based analytical methods to support in-depth characterization of biologics and other new modalities (antibody, bispecific, ADC etc), including but not limited to intact mass, cIEF-MS, peptide mapping, disulfide mapping and glycan analysis

REQUIREMENTS:

You love analytics and are passionate about using data to drive key business decisions. You love learning new technological skills and working through collaboration. You will provide expertise in the field of in-depth protein analysis as it pertains to biologics characterization and other novel therapy related work with possibility to support other modalities, as opportunities arise.

• Direct expertise in the analytical characterization for biologics and/or glycoproteins using peptide mapping, intact protein analysis, including post-translational modification analysis, and/or glycosylation elucidation.
• In-depth knowledge and hands-on experience in different types of analytical separation techniques and data processing analyses with focus on mass spectrometry applications.
• Knowledge of other analytical techniques such as chromatography (HPLC/UPLC), electrophoresis (CE-SDS, icIEF), biophysical methods
• Broad expertise and familiarity with protein and antibody production, drug discovery and CMC development; Proven experience supporting late-stage CMC, regulatory submissions, and commercial GMP manufacturing
• Strong experience in defining CQAs, specification setting, and building analytical control strategies for biologics
• Demonstrated leadership in matrix environments and cross-functional collaboration with MSAT and Quality
• Thorough understanding of biochemistry, structural biology and biologics discovery
• Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, ability to work on multiple projects simultaneously, as well ability to work independently and collaborate cross-functionally

EDUCATION (Indicate the mini. requirement & preferred discipline):

Ph.D degree with at least 5 years industry experience/MS with at least 10 years industry experience/BS with at least 15 years industry experience

Major：Analytical chemistry/ Biochemistry/Biophysics/Protein Chemistry, or related field