About This Role
This role is for an analytical scientist who will be responsible for developing and optimizing physiochemical analytical methods for various biologics, including monoclonal antibodies, bispecific antibodies, and ADCs. It involves leading projects, analyzing data to guide developability assessments, and establishing product characterization strategies using a range of advanced analytical techniques. The position supports process development, formulation, stability studies, and regulatory submissions, while also contributing to laboratory platform development and mentoring junior researchers.
Responsibilities
- Independently lead or be responsible for the development, optimization, confirmation/validation, transfer, and release support of physiochemical analytical methods for biologics such as monoclonal antibodies, bispecific antibodies, ADCs, and fusion proteins
- Summarize data from molecular discovery and developability assessment processes, analyze technical difficulties and challenges in method development, and guide developability assessment
- Establish and implement product physiochemical characterization strategies, including but not limited to:
- SEC-HPLC/UPLC for aggregates, fragments, and purity
- IEX-HPLC for charge variants
- RP-HPLC / HIC for hydrophobicity, DAR, and drug load distribution
- CE-SDS for reduced/non-reduced purity and fragments
- cIEF/icIEF for isoelectric point and charge heterogeneity
- Peptide mapping, glycosylation, free sulfhydryl, UV-Vis concentration, etc.
- Excipient content
- Conduct structural characterization and comparability studies using LC-MS/MS, high-resolution mass spectrometry, MALDI-TOF, etc., including:
- Intact protein/subunit molecular weight
- Peptide mapping, sequence coverage, disulfide bond localization
- N/O glycosylation, post-translational modifications
- DAR, drug load distribution, conjugation sites, free drug for ADCs
- Support process development, formulation, stability studies, forced degradation, comparability studies, and IND/BLA submissions
- Be responsible for writing and reviewing experimental protocols, technical reports, SOPs, and submission documents, and participate in OOS/OOT, deviation, change, and CAPA investigations
- Participate in laboratory platform construction, instrument management, method lifecycle management, and data integrity compliance
- Guide junior researchers and participate in team technical training and capability improvement
Requirements
- Master's degree or above in analytical chemistry, biochemistry, pharmacy, biotechnology, bioengineering, or a related major; PhD preferred
- Experience: 3+ years of experience in physiochemical analysis of biologics for master's degree holders; 5+ years for bachelor's degree holders
