Senior Viral Vector Downstream Process Scientist

BioSpace; United States; On-site; USD 100,000 - 130,000; Full time

Job summary

GenScript USA Inc/ProBio Inc. is seeking a bench-focused scientist to translate research processes to GMP manufacturing for viral vectors. You will develop, scale-up, and evaluate technology transfer of LVV and AAV processes, and potentially lead a small team.

This hands-on role requires collaboration with cross-functional teams, involvement in regulatory readiness, and the ability to drive process development from concept to manufacturing readiness. A Ph.D.

Qualifications

• Master’s or Ph.D. degree with 5+ years’ relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific 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 in CMC regulatory affairs for FDA, and EMA is a plus.
• Strong organizational skills and detailed documentation abilities are required.
• Work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques.
• Strong interpersonal, verbal, and written communication skills.
• Results oriented, be able to effectively prioritize and complete tasks on time.
• Collaboration and teamwork.

Responsibilities

• Hands-on experimental work in the development and optimization of downstream unit operations (TFF, Affinity/Ion Exchange/multimodal Chromatography, Viral clearance, Sterile filtration, etc.) for viral vector manufacturing process.
• Contribute to the planning, design, and execution of AAV/LVV purification-related experiments to analyze, interpret, and report data summary packages.
• Interact and collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies and strategies.
• Interact with cross functional teams (Analytic team, MFG, Supply chain, Facility, QA, QC) to support process technology transfer, cGMP risk evaluation, and deviation management.
• Maintain and follow detailed and comprehensive project timelines.
• Support in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.
• Present updates to project or upper management teams on process development and manufacturing support activities.
• Read and understand scientific literature in gene and cell therapy. Use the knowledge to generate ideas and contribute to process design and development.
• Perform other duties as assigned based on business needs.

Skills

Viral vector development

Scale-up / scale-down

DOE / statistics

Regulatory affairs (FDA/EMA)

Communication & teamwork

Education

Master’s or Ph.D. degree

Job description

GenScript USA Inc/ProBio Inc. is seeking a bench-focused scientist to translate research processes to GMP manufacturing for viral vectors. You will develop, scale-up, and evaluate technology transfer of LVV and AAV processes, and potentially lead a small team.

This hands-on role requires collaboration with cross-functional teams, involvement in regulatory readiness, and the ability to drive process development from concept to manufacturing readiness. A Ph.D.