Job Title: Senior Research Associate I – Downstream Process Development (Protein Purification)
Job Summary
We are seeking a highly motivated Senior Research Associate I to support process development activities focused on biologics purification. This role involves hands-on laboratory work, execution of purification experiments, data analysis, and collaboration with cross-functional teams to support process optimization, characterization, and technology transfer to GMP manufacturing.
Key Responsibilities
- Plan and execute laboratory experiments to support downstream process development and project goals
- Perform protein purification using techniques such as chromatography, tangential flow filtration (UF/DF), and filtration
- Analyze and interpret experimental data, ensuring data quality and identifying anomalies
- Contribute to process optimization, characterization, and scale-up activities
- Collaborate with cross-functional teams including Process Development, Analytical, and Manufacturing
- Support technology transfer activities from development to GMP manufacturing
- Assist in troubleshooting purification processes and recommending improvements
- Document experimental results and contribute to technical reports, validation documents, and regulatory filings
- Present data, results, and conclusions in team meetings
- Maintain compliance with cGMP and safety standards, including handling potent compounds upon training
Required Qualifications
- BS degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, or related field with 2+ years of relevant experience, OR
- MS degree in a relevant scientific discipline
Preferred Qualifications
- Hands-on experience in biologics purification / downstream process development
- Experience with tangential flow filtration (TFF/UFDF), chromatography, and filtration techniques
- Familiarity with purification of monoclonal antibodies (mAbs) or other biologics (e.g., bispecifics, fusion proteins, ADCs)
- Exposure to analytical techniques such as SEC-HPLC, CE (reducing/non-reducing), or HCP testing
- Knowledge of cGMP environments, process scale-up, and technology transfer
- Understanding of downstream unit operations including centrifugation, filtration, chromatography, and virus clearance
Skills & Competencies
- Strong experimental design and problem-solving skills
- Ability to analyze and interpret complex scientific data
- Excellent technical writing and documentation skills
- Effective communication and collaboration in a team-oriented environment
- Self-motivated, detail-oriented, and eager to learn
Work Environment
- On-site laboratory role
- Requires adherence to safety protocols and handling of potent compounds
Nice to Have
- Experience with multiple expression systems (mammalian and microbial)
- Exposure to regulatory documentation and process validation
