Sr. Scientist, Downstream Process Development

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. ProBio brings together multidisciplinary expertise to accelerate development and manufacturing through customized, comprehensive services. With locations in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing), ProBio has helped customers obtain more than 150 IND approvals since October 2017.

About the role

The position reports to the Associate Director, Downstream Viral Vector Process Development & MSAT Department. This role is ideally suited for a dynamic bench-focused individual to support or lead the translation of research processes to GMP-compliant manufacturing. Responsibilities include developing, scaling up, and evaluating the technology transfer of viral vector processes. This is an opportunity to join a fast-paced company, expand technical expertise, and potentially lead a small team in the near future.

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 processes.
• 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 and external partnerships to evaluate and implement new bioprocessing technologies and strategies.
• Engage with cross-functional teams (Analytic, Manufacturing, 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 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 to generate ideas and contribute to process design and development.
• Perform other duties as assigned based on business needs.

Requirements

• 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.
• Experience with LVV and AAV process development is a plus.
• 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.
• Ability to 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 with the ability to effectively prioritize and complete tasks on time.
• Collaboration and teamwork.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Paid parental leave after three months of employment.
• Paid time off policy including vacation time, personal time, sick time, floating holidays, and company holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance, short- and long-term disability coverage.
• Legal assistance and supplemental plans (pet, critical illness, accident, and hospital indemnity insurance).
• Commuter benefits, well-being initiatives, and peer-to-peer recognition programs.