Senior Protein Scientist, Downstream Process Development

Neion Bio•New York, NY

21h•$130,000 - $170,000

About The Position

We are looking for a talented scientist to lead the development, optimization, and scale-up of downstream purification processes for monoclonal antibodies and other biologics, from early development through clinical and commercial manufacturing. This role is responsible for designing robust, scalable, and regulatory-compliant purification processes, with a focus on translating lab-scale workflows into high-yield, cost-effective GMP manufacturing processes. The individual will serve as a technical leader across process development, tech transfer, and manufacturing.

Requirements

5+ years of industry experience in downstream process development for monoclonal antibodies or closely related biologics
Ph.D. in biochemical engineering, chemical engineering, biochemistry, or related field; or equivalent industry experience
Demonstrated experience scaling purification processes from bench scale to pilot and/or commercial manufacturing scale
Deep expertise in core mAb purification unit operations: Protein A affinity chromatography Ion exchange (IEX), hydrophobic interaction chromatography (HIC) Viral inactivation and viral filtration Ultrafiltration/diafiltration (UF/DF)
Expertise in chromatography process development and scale-up, including mass transfer and capacity studies, Design of Experiments (DoE) screening for performance optimization, as well as productivity and resin lifecycle modeling
Hands-on experience with manufacturing-relevant equipment (ÄKTA process systems, large-scale columns, TFF systems)
Demonstrable success in tech transfer to GMP manufacturing environments (internal or CDMO)
Experience managing external partners (CDMOs) and overseeing manufacturing campaigns
Experience overseeing manufacturing campaigns, including managing timelines, risk, and troubleshooting efforts to support tech transfer
Appetite for fast-paced startup environment and teamwork

Responsibilities

Design, develop, and optimize downstream purification processes for monoclonal antibodies and other therapeutic and non-therapeutic proteins, including clarification, capture, intermediate, and polishing steps
Lead scale-up activities from bench to pilot and commercial manufacturing, including process modeling and tech transfer to CDMOs.
Author and review technical reports, development protocols, and regulatory documentation, in support of tech transfer
Lead or support technology transfer to GMP manufacturing sites
Collaborate with upstream, analytical, and quality teams to ensure process robustness and product quality
Support process validation activities
Evaluate and implement new purification technologies to improve efficiency, yield, and cost of goods