Research Associate, Process Analytics

Avid Bioservices•Tustin, CA

3d•Onsite

About The Position

The Research Associate, Process Analytics applies advanced scientific knowledge acquired through a specialized course of study to plan and execute analytical studies supporting cell line development, upstream and downstream process development, formulation development, process characterization, and other non-GMP studies. Working with limited day-to-day supervision, the role selects appropriate analytical approaches, interprets data, investigates atypical results, and recommends scientifically supported next steps. The Research Associate owns assigned analytical studies and serves as a technical resource to development teams.

Requirements

Bachelor's degree in biology, biochemistry, chemistry, biotechnology, pharmaceutical sciences, or a related scientific field, providing the advanced knowledge required to perform the analytical work.
One or more years of relevant hands-on experience in process development, quality control, biologics characterization, or a related analytical laboratory, or equivalent experience gained through advanced scientific coursework or internships.
Demonstrated ability to apply scientific principles to plan analytical work, interpret data, investigate atypical results, and recommend technical next steps.
Hands-on experience with analytical biochemistry, chromatography, electrophoresis, protein characterization, or comparable biologics testing.

Nice To Haves

Experience with Waters chromatography systems and Empower software.
Experience with Maurice, Compass, ELISA, qPCR, or comparable analytical platforms.
Experience with analytical method development, qualification, or transfer.

Responsibilities

Plan and execute routine and non-routine analytical studies supporting cell line development, upstream and downstream process development, formulation development, process characterization, and other non-GMP studies.
Select appropriate analytical methods, experimental conditions, controls, and data-analysis approaches within established program objectives.
Execute and interpret assays such as HPLC or UPLC, icIEF, plate-based assays, residual DNA or qPCR, pH, osmolality, and SDS-PAGE, applying scientific judgment to evaluate results.
Investigate atypical or unexpected results, assess data quality and validity, and recommend scientifically supported next steps.
Troubleshoot routine method and instrument performance issues and determine appropriate technical resolutions within the role’s authority.
Author and revise analytical protocols, methods, technical summaries, and investigation documentation to maintain data integrity and traceability.
Support analytical method development, qualification, and transfer activities in partnership with Analytical Development.
Present analytical conclusions and recommendations to Process Development and cross-functional project teams.
Contribute to continuous improvement of analytical approaches, throughput, data quality, and turnaround time.