Scientist, Analytical Development

Role Summary

This position will serve as analytical SME to support Biologics (such as antibody, bioconjugates) CMC development. Develop, establish, and qualify/validate analytical methods used to monitor the critical product quality of drug substance and drug product. Contribute to the development and implementation of analytical development strategies and workflows. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of process intermediate, drug substance, drug product at all stages of development process.

Responsibilities

• Lead analytical method development and qualification/validation activities for the characterization of antibody and antibody conjugate utilizing various analytical techniques including but not limited to SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF, Bioassays (ELISA, cell based assays), qPCR, LC-MS, NGS
• Support cell line development to enable faster and informed decision making when needed. Key analytical areas for cell line development include but are not limited to high throughput titer analysis, purity analysis, N-glycan analysis, charge variant analysis, sequence variant analysis, genomic integrity analysis
• Represent analytical development on CMC cross-functional teams and maintain accountability for analytical deliverables
• Lab Personnel and ensure laboratory safety practices
• Support off-site analytical method transfers, manufacturing support, and interaction with external vendors when needed
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC development strategies
• Other duties as assigned

Qualifications

• BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions OR
• MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above OR
• PhD in chemistry or closely related field and some industry or relevant experience a plus
• Expert knowledge and understanding of analytical chemistry and a thorough understanding of antibody bioprocess including cell line development, upstream development, downstream development, and formulation development
• Extensive experience and expertise with antibody modalities, focusing on analytical development
• Proficient in characterization of antibody modalities using various analytical technologies including but not limited to liquid chromatography (SEC, HILIC, RP, HIC, AEX, CEX), capillary electrophoresis (Maurice, PA800+, Labchip GX/GXII, etc.), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry, ELISA, bioassays, molecular analysis (southern blot, northern blot, NGS, etc.)
• Method development, qualification, validation, and transfer experience in Analytical Development
• Comprehensive understanding of cGMP requirements in drug substance and drug product
• Expert knowledge of cross-functional understanding related to drug development
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
• Excellent laboratory and productivity skills
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent problem solving and critical thinking skills