Sr. Scientist, Downstream Process Development

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

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; 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 have

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

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 (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