Sr. Research Associate, Analytical Development
Listed on 2026-07-04
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Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Research/Development
Regulatory Compliance Specialist, Biotech Research
Avid Bioservices is a leading clinical and commercial biologics CDMO dedicated to developing and manufacturing life‑saving biopharmaceuticals.
Sr. Research Associate, Analytical DevelopmentThe Sr. Research Associate, Analytical Development will develop, validate, and transfer cutting‑edge protein biologics methods—including cell‑based ELISA, HPLC, CE, PCR, and SDS‑PAGE—to the Quality Control testing team. The role involves collaboration with analytical and process development scientists, participation in regulatory inspections, and support for continuous improvement initiatives.
Key Responsibilities- Perform and review routine wet chemistry assays, ELISA/cell‑based immunoassays, electrophoresis (SDS‑PAGE/IEF), and HPLC.
- Train or supervise junior analysts and serve on interdepartmental or technology‑transfer teams as needed.
- Develop, review, revise, and document test methods, standard operating procedures, and perform trending analysis.
- Act as study lead for validation, investigation, and method‑development projects.
- Use prior experience in HPLC/CE or potency/ELISA assay methodologies as required.
- Maintain knowledge of company cGMPs and relevant industry regulations, and participate in regulatory inspections.
- Support continuous improvement initiatives.
- Perform other duties as assigned.
- 4+ years of industry experience in a QC or analytical laboratory with a BS degree (preferred disciplines: Biochemistry, Chemistry, Biology, or pharmaceutical sciences).
- 2+ years of industry experience in a QC or analytical laboratory with an MS degree.
- Experience with analytical biochemistry methods and equipment.
- Proficient in writing reports, procedures, and specifications.
- Knowledge of GMPs and regulatory audits.
- Essential experience with potency/ELISA and/or HPLC methodologies.
- Experience with protein characterization, electrophoresis, chromatography, and assay validation/qualification.
- Experience with Octet, liquid handler, and Maurice.
Full‑time position operating Monday through Friday; overtime, including weekends, and off‑site client or regulatory meetings may be required.
Compensation- Competitive compensation package: base salary ranging from $84,000 to $105,000 annually, plus performance‑based bonuses.
- Benefits include health, dental, and vision insurance, 401(k) matching, and paid time off.
- Opportunities for career growth and development in a supportive and inclusive environment.
The role requires a combination of sitting, standing, and walking; occasional lifting of up to 20 pounds; exposure to electrical shocks, toxic chemicals, vibrations, or loud noise. Reasonable accommodations are available for individuals with disabilities.
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