Sr. Scientist, Downstream Process Development

GenScript/ProBio

4h • Onsite

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.

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.
• Strong understanding of process scale-up and scale-down modeling.
• Good understanding of Design of Experiment (DOE) and statistical analysis.
• 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.

Nice To Haves

• Experience with LVV and AAV process development is a plus.
• Previous experience in viral vector process development and manufacturing is highly preferred.
• Experience in CMC regulatory affairs for FDA, and EMA is a plus.

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.

Benefits

• medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• paid parental leave after just three (3) months of employment
• paid time off policy that includes 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
• supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• commuter benefits
• well-being initiatives
• peer-to-peer recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior