Description

Your Role:
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. Through independent discretion and advanced scientific expertise, the Senior Research Associate helps set the technical direction for analytical workstreams across development programs.

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, providing the advanced knowledge required to perform the analytical work; 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.

Position Type/Expected Hours of Work:

This role is a full-time onsite position in Tustin, CA. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $76,000 to $99,900 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.