Research Associate, Formulation Development
Avid Bioservices
Summary
The Research Associate, Formulation Development independently plans and executes formulation-development studies supporting protein-based biologics, including monoclonal antibodies (mAbs), across preclinical and clinical programs. Applying advanced scientific knowledge acquired through a specialized course of study, the role interprets formulation and stability data, investigates atypical results, and recommends scientifically supported next steps. Working with limited day-to-day supervision, the Research Associate owns assigned studies and deliverables and serves as a technical resource to development teams.
Job description
Your Role
The Research Associate, Formulation Development independently plans and executes formulation-development studies supporting protein-based biologics, including monoclonal antibodies (mAbs), across preclinical and clinical programs. Applying advanced scientific knowledge acquired through a specialized course of study, the role interprets formulation and stability data, investigates atypical results, and recommends scientifically supported next steps. Working with limited day-to-day supervision, the Research Associate owns assigned studies and deliverables and serves as a technical resource to development teams.
Key Responsibilities
- Independently plan and execute formulation-development studies, including buffer and excipient preparation, protein concentration measurements and diafiltration, vial fills, stability studies, and analytical characterization, within established program objectives.
- Generate and interpret analytical data such as pH, conductivity, protein concentration, turbidity, viscosity, SEC-HPLC, CEX, and icIEF, applying scientific judgment to evaluate results.
- Investigate atypical or unexpected formulation and stability results, assess data quality and validity, and recommend scientifically supported next steps.
- Troubleshoot routine formulation, method, sample, and instrument issues and determine appropriate technical resolutions within the role’s authority.
- Author and revise protocols, technical reports, development summaries, and investigation documentation to maintain data integrity and traceability.
- Present formulation conclusions and recommendations to Process Development and cross-functional stakeholders.
- Contribute to continuous improvement of formulation approaches, laboratory efficiency, data quality, and turnaround time.
Minimum Qualifications
- Bachelor's degree in a biological or physical science, such as biochemistry or chemistry, providing the advanced knowledge required to perform the formulation-development work.
- One or more years of relevant hands-on laboratory experience with demonstrated working knowledge of scientific principles, or equivalent experience gained through advanced scientific coursework or internships.
- Demonstrated ability to apply scientific principles to plan studies, interpret data, investigate atypical results, and recommend technical next steps.
- Hands-on experience with protein-based biologics, formulation development, protein purification, or analytical characterization.
Preferred Qualifications
- Master's degree in biochemistry, chemistry, or a related field.
- Hands-on experience with monoclonal antibodies (mAbs) and stability study design.
- Experience with SEC-HPLC, CEX, icIEF, or comparable analytical characterization techniques.
- Experience authoring protocols, technical reports, or development summaries.
Position Type/Expected Hours of Work
This role is a full-time, exempt, 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.
Requirements
- Bachelor's degree in a biological or physical science, such as biochemistry or chemistry
- One or more years of relevant hands-on laboratory experience
- Demonstrated ability to apply scientific principles to plan studies, interpret data, investigate atypical results, and recommend technical next steps
- Hands-on experience with protein-based biologics, formulation development, protein purification, or analytical characterization
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) matching
- Paid time off
- Performance-based bonuses
- Career growth opportunities
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.