Sr. Scientist, Downstream Process Development

genscript; United States; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Paid parental leave

PTO & holidays

Job summary

GenScript USA Inc./ProBio Inc. is seeking a qualified scientific professional to translate research processes into GMP-compliant manufacturing for viral vectors. You will develop, scale-up, and evaluate technology transfer of LVV and AAV processes, with potential to lead a small team.

The ideal candidate holds a Master's or PhD with 5+ years in biotech development, excels in DOE and data analysis, and collaborates across analytical, manufacturing, QA, and regulatory teams to advance projects.

Qualifications

• Master's or PhD with 5+ years in biotech/viral vector development.
• Experience with LVV and AAV process development.
• Strong DOE and statistical analysis skills.
• Regulatory affairs experience with FDA/EMA is a plus.
• Excellent documentation and collaboration skills.

Responsibilities

• Develop and optimize downstream unit operations for viral vector manufacturing.
• Plan and perform AAV/LVV purification experiments and data reporting.
• Collaborate with internal/external partners to evaluate new bioprocessing tech.
• Support cGMP transfer, risk evaluation, and deviations.
• Prepare CMC sections for regulatory submissions.
• Present progress to management and read current literature for ideas.

Skills

DOE

Statistical analysis

Scientific communication

Project coordination

Education

Master's degree in Chemical/Biochemical Engineering

Ph.D. in related field

Tools

LVV purification techniques

Job description

About GenScript

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, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About ProBio

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. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

Position Overview

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/lead translation of research process to GMP-compliant manufacturing, and will develop, scale-up, and evaluate the technology transfer of viral vector processes. This is a great opportunity to join a fast-paced company, develop, and expand technical expertise to lead by example 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 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.

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. 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.

Benefits

• Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays.
• Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Equal Opportunity Statement

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workf