(Sr). Scientist, Downstream Process Development

GenScript/ProBio • Pennington, NJ

102d

About The Position

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. 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.

Requirements

• 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.
• Particular experience in biotech development with 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.
• Ability to work independently in hands-on laboratory setting.
• Strong interpersonal, verbal, and written communication skills.
• Results oriented with the ability to effectively prioritize and complete tasks on time.
• Collaboration and teamwork skills.
• Comfortable in a fast-paced, multi-tasking biotech environment.

Nice To Haves

• Experience with LVV and AAV process development.
• Experience in CMC regulatory affairs for FDA, and EMA.

Responsibilities

• Support/lead translation of research process to GMP-compliant manufacturing.
• Develop, scale-up, and evaluate the technology transfer of viral vector processes.
• Perform hands-on experimental work in the development and optimization of downstream unit operations.
• Contribute to the planning, design, and execution of AAV/LVV purification-related experiments.
• Interact and collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies.
• Interact with cross functional teams 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.
• 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.
• Perform other duties as assigned based on business needs.

Benefits

• Equal opportunity/affirmative action employer.
• Drug-free workplace.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees