Sr). Scientist, Downstream Process Development

Position Overview

The role reports to the Associate Director, Downstream Viral Vector Process Development & MSAT Department. The scientist will translate research processes to GMP‑compliant manufacturing, scale‑up, and evaluate technology transfer of viral vector processes. This opportunity supports a fast‑paced company, expands technical expertise, and potentially leads a small team in the near future.

• Hands‑on experimental work in downstream unit operations (TFF, affinity/ion exchange, multimodal chromatography, viral clearance, sterile filtration) for viral vector manufacturing.
• Plan, design, and execute AAV/LVV purification experiments to analyze and report data packages.
• Collaborate with internal/external partners to evaluate and implement new bioprocessing technologies and strategies.
• Work with cross‑functional teams (Analytical, Manufacturing, Supply Chain, Facility, QA, QC) to support process technology transfer, cGMP risk evaluation, and deviation management.
• Maintain and follow detailed project timelines.
• Prepare CMC sections for regulatory submissions (IND, annual reports, BLA), invention disclosures, progress reports, and publications.
• Present updates to project or upper management teams on process development and manufacturing support activities.
• Review scientific literature in gene and cell therapy to generate ideas and contribute to process design and development.

• Bachelor’s degree with 3‑7 years, or Master’s/Ph.D. with 1‑3 years relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or related discipline in biotech development with particular experience in gene and cell therapy product design.
• Previous experience in viral vector process development and manufacturing is highly preferred.
• Strong understanding of process scale‑up and scale‑down modeling.
• Good understanding of Design of Experiment (DOE) and statistical analysis.
• Experience with CMC regulatory affairs for FDA and EMA is a plus.
• Strong organizational skills and detailed documentation abilities are required.
• Work independently in a hands‑on laboratory setting, self‑motivated to learn and develop new techniques.
• Strong interpersonal, verbal, and written communication skills.
• Results‑oriented, able to effectively prioritize and complete tasks on time.
• Collaboration and teamwork.
• Comfortable in a fast‑paced, multi‑tasking biotech environment.

The salary range, dependent upon experience level, is $80,000 - $110,000 annually.

GenScript USA Inc./Pro Bio Inc. is a proud equal opportunity/affirmative action employer offering a drug‑free workplace. The company ensures equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.