Sr. Research Associate - Down Process Development
Oceanside, CA (onsite)
Schedule: Standard Office Hours
Duration: 12-Month Contract
Pay: $35-40/hr, depending on experience
Job Responsibilities
In this role, you will support the biologics development group with a focus on protein purification process development and characterization. Key responsibilities include:
- Planning and executing experiments on-site to support process development activities and project goals.
- Selecting and applying appropriate methods and techniques for experiments.
- Proactively researching new methods and techniques, recommending alternatives, and consulting with senior personnel to address challenges.
- Presenting results, data interpretation, and conclusions during group meetings.
- Promoting a safety-first approach and maintaining readiness to work with highly potent compounds after appropriate training.
- Collaborating with cross-functional teams to ensure effective process transfer to GMP manufacturing and contribute to regulatory filings.
Essential Duties and Job Functions
- Independently designing and conducting experiments to support process definition, optimization, and characterization.
- Interpreting experimental outcomes, evaluating data quality, and identifying anomalous results.
- Collaborating with the purification team to drive process development and improvement.
- Acting as a process development representative during technology transfers, troubleshooting, and identifying future opportunities for process enhancements.
- Preparing technical documentation, including regulatory filings and process validation reports.
- Monitoring scientific literature and attending conferences to inform development strategies.
Knowledge & Skills
- Hands-on experience in downstream process development, including centrifugation, filtration (tangential/normal flow), chromatography, and virus clearance.
- Knowledge of biologics purification techniques with a focus on tangential flow filtration, conjugation, and filtration.
- Familiarity with cGMPs, technology transfer, and scaling up bioprocesses.
- Proficiency with analytical operations such as SEC/HPLC and CE (R/NR); knowledge of HCP testing is advantageous.
- Ability to effectively communicate ideas, interpret data, and collaborate in a multidisciplinary environment.
- Strong technical writing skills and organizational abilities.
- Experience with diverse modalities, including mAbs, antibody-drug conjugates, bispecifics, and virus particles.
Education & Experience
- Bachelor's degree in Chemical/Biochemical Engineering, Biochemistry, Chemistry, or a related scientific field, with 2+ years of relevant experience; OR
- Master's degree in a related field with 1-2+ years of relevant experience.
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