Scientist II

Scientist II – Analytical Development (Biologics)

Status:
Contract to hire or direct hire with right experience

Overview

A growing biotech organization is looking for a driven Scientist II to support analytical development activities for next-generation biologic therapeutics. This position is based in the San Diego area and plays a key role in method development, characterization, and early CMC support for complex protein and antibody formats.

The role is ideal for someone who enjoys hands-on bench work, problem-solving across multiple analytical platforms, and collaborating with cross-functional teams advancing early-stage biologics.

Primary Responsibilities

• Develop, refine, and implement analytical methods for characterization, release, and stability of diverse biologic molecules (e.g., antibodies, bispecifics, conjugates).
• Perform routine and non-routine analyses using platforms such as HPLC (SEC, HIC, IEX), capillary electrophoresis (icIEF, CE-SDS), UV-Vis, pH/osmolality measurements, and impurity assessments (e.g., HCP).
• Interpret complex data sets, identify trends, and deliver insights that guide research and process development decisions.
• Maintain high-quality documentation in electronic lab notebooks and prepare technical documents including study protocols, reports, and method descriptions.
• Recommend improvements to analytical workflows and stay current with emerging technologies in separation sciences and biologics analysis.
• Serve as the analytical representative on internal project teams spanning Discovery, Process Development, and CMC.
• Support external activities such as method transfer, analytical lifecycle management, and stability program oversight.

Qualifications

• Advanced degree in analytical chemistry, biochemistry, or a related field, with ~3+ years of relevant industry experience in biologics analytical development (or an equivalent combination of education and experience).
• Deep expertise in separation science and demonstrated capability in method development and qualification/validation.
• Strong practical experience operating modern analytical instrumentation for biotherapeutic characterization.
• Solid understanding of protein structure, degradation pathways, and common challenges in biologic development.
• Comfortable working in a small, fast-moving environment and willing to both learn from and mentor others.
• Excellent technical writing skills and familiarity with drafting content for regulatory submissions.
• Knowledge of early-stage development principles, manufacturing science/technology, unit operations, and GxP concepts.
• Experience supporting formulation, process development, or drug product teams is a plus.