Senior Research Associate, Analytical Development

Role Summary

Senior Research Associate to participate in designing and executing experiments, and perform sample analysis utilizing HPLC, CE-SDS, iCIEF, and capillary CE-SDS ELISA (simple Western). These activities will support CMC, discovery, preclinical, and clinical development of existing and new lead candidates. This hands‑on position requires effective communication and documentation of results to enable advancement of novel research molecules toward development of clinical candidates, ultimately supporting late‑stage development and commercialization.

The role directly supports the discovery of next‑generation immuno‑oncology drugs.

Location:

On‑site in San Diego, CA.

• Develop and perform HPLC and UPLC assays with minimal supervision including SEC, HIC, IEX, and RP.
• Develop and perform iCIEF and CE-SDS assays.
• Develop and perform ELISAs.
• Perform DLS/SLS analysis using an UNcle instrument and generate datasets that will be used for formulation development studies.
• Perform subvisible particulate matter analysis by HIAC.
• Perform formulation development studies and execute clinical in-use stability studies, transfer formulation knowledge internally.
• Design, conduct, analyze, interpret, and report laboratory experiments; summarize results for meetings and regulatory filings.
• Write and manage SOPs and test methods, train colleagues and facilitate method transfer to partners and CDMOs.
• Manage and maintain required reagents, laboratory environment, and equipment needed to carry out assignments.
• Draft development reports, method qualification protocols, and method qualification reports.
• Prepare presentations for team meetings.
• Work closely with team leaders to complete highest priority work to reach goals and milestones.
• Other duties as assigned.

• Bachelor’s degree in related scientific discipline with 4-6 years of relevant industry experience or Master’s degree with 3-5 years of relevant industry experience required.
• Strong benchtop skills, experience with analysis of protein biologics and peptides.
• Proficient with the development of HPLC and UPLC assays; at least 3 years of experience is required. SEC, RP, HIC, and IEX experience is desired.
• Experience developing and performing ELISAs.
• Knowledge and familiarity in employing various analytical techniques, to include but not be limited to: CE-SDS, iCIEF.
• Experience with DLS/SLS (UNcle), HIAC, HIC and CE-SDS ELISA (Simple Western) blotting or similar technology preferred.
• Experience with formulation development with focus on antibodies or bispecifics is highly desired.
• Proven experience with writing and maintaining SOPs, ability to train others and to transfer methods to external partners.
• Ability to perform routine testing and to follow SOPs in a highly accurate and reproducible manner.
• Desire and ability to learn new technologies, thinking outside the box, and exploring new approaches to innovate.
• Training on project specific assays and ability to train others.
• Ability to work independently, anticipate, and solve problems in a proactive fashion.
• Excellent computer skills, proficiency with Microsoft Excel and PowerPoint required.
• Strong oral and written communication skills a must.