GenScript · 2 months ago
(Sr). Scientist, Downstream Process Development
Pennington, NJ
Full-time
Onsite
Mid, Senior Level
$80K/yr - $110K/yr
3+ years expGenScript Biotech Corporation is a global biotechnology group committed to improving health through biotechnology. The Senior Scientist in Downstream Process Development will support and lead the translation of research processes to GMP-compliant manufacturing, focusing on the development and optimization of viral vector processes.
BiotechnologyGeneticsManufacturing
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
Qualification
Required
Bachelor's degree with 3-7 years, or Master's or Ph.D. degree with 1-3 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 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
Must be comfortable in a fast-paced, multi-tasking biotech environment
Company
GenScript
GenScript USA, Inc. is a leading contract research organization (CRO) specialized in biological research and drug discovery/development
5001-10000 employees
H1B Sponsorship
GenScript has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (28)
2023 (19)
2022 (11)
2021 (11)
2020 (12)
Funding
Current Stage
Public CompanyTotal Funding
unknown2015-12-31IPO
Leadership Team
Larry Wang
Co-Founder & Board Director
Shiniu Wei
Chief Financial Officer
Recent News
Morningstar.com
2025-11-10
Company data provided by crunchbase