BioSpace has been engaged to assist a privately-held biotech company who is developing a novel class of therapeutics to bring new medicines to patients with unmet medical needs. The company leverages their proprietary antibody, conjugation, and medicinal chemistry platforms to inhibit or degrade intracellular target proteins. We are advancing our first set of oncology candidates toward preclinical development.
We are seeking to build our in-house analytical capabilities to help advance quality compounds toward the clinic. The successful candidate will have a strong background in analytical chemistry and a passion for driving high-impact projects in the anti-cancer drug discovery space. He/she will conduct bench-based research and support analytical development for our preclinical candidates. The successful candidate will be the analytical subject matter expert and lead this function for the company.
● Act as the analytical function lead on research and CMC project teams
● Coordinate selection, purchase and setup, of high resolution LC/MS instrumentation (SQD, ion trap or Q-ToF).
● Maintain a suite of HPLC and MS systems
● Set up a system for integrating data analysis and storage across multiple instruments
● Develop LC-MS methods to support analysis of ADCs, antibodies and small molecules: intact protein analysis, subunit analysis, peptide mapping, quantitative small molecule analysis, etc.
● Develop and optimize HPLC assays (SEC, HIC, RPLC) to support discovery research and process development
● Develop bioassays for analytes from plasma, cells, and other biological matrices
● Execute routine characterization of research samples - ADCs, antibodies, and small molecules
● Execute routine bioassays and analysis of DMPK samples and/or coordinate testing at CRO
● Develop pre-formulations for small molecule dosing in preclinical species
Requirements and Qualifications
3-10 years of experience in pharmaceutical setting supporting discovery analytics for small molecule and/or biologics programs
Deep knowledge of MS methods required
Strong record of developing robust analytical methods for diverse molecules. Experience with ADCs and new modalities highly desirable.
Experience with high-throughput workflows and automation is a plus.
Working knowledge of cGMP, GLP, ICH guidance’s, USP, NF, and other global compendia/guidance a plus