Sr. Research Associate, Process Analytics
Avid Bioservices
Summary
The Senior Research Associate, Process Analytics independently performs, coordinates, and provides technical guidance for analytical work supporting cell line development, upstream and downstream process development, formulation development, process characterization, and other non-GMP studies. Serving as a technical resource for multiple analytical methods and instruments, the role independently determines analytical approaches, troubleshoots complex technical problems, reviews analytical data, and supports implementation of new analytical technologies.
Job description
Key Responsibilities
- Independently perform and coordinate routine and non-routine analytical studies, determining testing strategies, priorities, and approaches supporting development programs.
- Serve as a technical resource and method owner for selected analytical platforms, including HPLC or UPLC, CE-SDS, icIEF, plate-based assays, residual DNA or qPCR, pH, osmolality, and SDS-PAGE.
- Lead troubleshooting and resolution of complex instrument, method, system-suitability, and data-integrity issues, serving as a technical escalation point for the laboratory.
- Design and lead analytical comparability studies, special studies, and method-transfer activities in partnership with Analytical Development.
- Perform technical review of analytical data and documentation generated by Research Associates and other team members, as assigned.
- Evaluate scientific risk and recommend analytical approaches that influence process development and program-level decisions.
- Support development, implementation, and optimization of new analytical technologies and high-throughput workflows.
- Provide technical mentorship, guidance, and training to Research Associates and laboratory personnel without direct people-management responsibility.
- Represent Process Analytical in cross-functional project meetings and communicate technical findings and recommendations to stakeholders.
Minimum Qualifications
- Bachelor's degree in biology, biochemistry, chemistry, biotechnology, pharmaceutical sciences, or a related scientific field; a master's degree is a plus.
- Three or more years of relevant hands-on experience in process development, quality control, biologics characterization, or a related analytical laboratory, including demonstrated independent ownership of analytical work, or an equivalent combination of advanced education and experience.
- Demonstrated experience serving as a technical resource, troubleshooting complex analytical methods or instrumentation, and reviewing technical data.
- Strong hands-on experience with analytical biochemistry, chromatography, electrophoresis, protein characterization, or comparable biologics testing.
Preferred Qualifications
- Experience with Waters chromatography systems and Empower software.
- Experience with Maurice, Compass, ELISA, qPCR, or comparable analytical platforms.
- Experience with method transfer, comparability studies, or implementation of new analytical technologies.
- Experience providing technical training, mentorship, or data review in a laboratory setting.
Requirements
- Bachelor's degree in biology, biochemistry, chemistry, biotechnology, pharmaceutical sciences, or a related scientific field
- Three or more years of relevant hands-on experience in process development, quality control, biologics characterization, or a related analytical laboratory
- Demonstrated experience serving as a technical resource, troubleshooting complex analytical methods or instrumentation, and reviewing technical data
- Strong hands-on experience with analytical biochemistry, chromatography, electrophoresis, protein characterization, or comparable biologics testing
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) matching
- Paid time off
- Performance-based bonuses
Company overview
Avid Bioservices is a leading contract development and manufacturing organization (CDMO) specializing in biologics derived from mammalian cell culture systems. Founded in 1993 and headquartered in Tustin, California, the company has over 30 years of experience in biologics manufacturing. Avid provides comprehensive process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. Their expertise spans from early-stage process development to full-scale commercial manufacturing, including cell line development, upstream and downstream optimization, analytical methods development, and regulatory submissions support. The company has produced more than 250 commercial batches and has five commercial products marketed in over 90 countries. With state-of-the-art facilities and a flawless quality track record maintained for over a decade, Avid Bioservices focuses on transforming the CDMO experience through personalized processes, unrivaled expertise, and exceptional quality standards. The company was recently acquired by GHO Capital Partners and Ampersand Capital Partners in a $1.1 billion transaction, positioning it for continued growth in the biologics manufacturing sector.