Position Summary:

We are seeking a highly skilled and motivated Senior Research Associate, Downstream Processing to join our dynamic team. The successful candidate will play a critical role in research projects, with a focus on the downstream processing part of AAV production using whole plants. The Senior Research Associate will work closely with the Downstream Processing Scientist and cross-functional teams to ensure the efficient and cost-effective production of high-quality products in compliance with regulatory standards. This position requires an individual with a strong background in Chromatography, molecular biology and hands-on experience in purifying AAVs, proteins, or vaccines. The ideal candidate will have experience working in a GMP environment and be ready to start immediately and contribute to our innovative research initiatives.

Key Responsibilities:

• Assist in the development and optimization of downstream processes for the purification of biologics, including chromatography, filtration, ultrafiltration/diafiltration (UF/DF), and viral clearance.
• Design and execute experiments to evaluate and improve process performance, yield, and product quality.
• Purify material for research purposes.
• Assist in scaling up and transferring downstream processes from the laboratory to pilot and manufacturing scales, ensuring robustness and reproducibility.
• Collaborate with upstream process development and manufacturing teams to integrate downstream processes into overall production workflows.
• Perform process characterization and validation studies to support regulatory submissions and ensure compliance with current Good Manufacturing Practice (cGMP) guidelines.
• Troubleshoot and resolve process-related issues during development, scale-up, and production.
• Prepare technical reports, process descriptions, and Standard Operating Procedures (SOPs) to document process development activities.
• Stay current with advancements in downstream processing technologies and apply best practices to enhance process efficiency and product quality.
• Provide technical support to manufacturing teams during process implementation and commercial production.
• Participate in cross-functional project teams and contribute to project planning, risk assessment, and decision-making processes.

Qualifications:

• M.S. or B.S. in Biochemistry, Chemical Engineering, Biotechnology, or a related field, with 3+ years (M.S.) or 5+ years (B.S.) of relevant experience in downstream process development in the biopharmaceutical industry.
• Hands-on experience with biologics downstream processing techniques such as chromatography (affinity, ion exchange, size exclusion), filtration (depth filtration, tangential flow filtration), and UF/DF.
• Experience with DSP in AAV is a plus.
• Familiarity with process scale-up, technology transfer, and cGMP requirements.
• Strong problem-solving skills and the ability to troubleshoot complex process issues.
• Proficiency in data analysis, process optimization, and statistical tools (e.g., Design of Experiments).
• Knowledge of regulatory guidelines and quality control procedures in a research environment is preferred.
• Strong analytical and problem-solving skills, with attention to detail.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a collaborative team.

This is a full time, onsite position. No agencies please.