Protein Scientist, Downstream Process Development
Job Description
Job Description
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.
Key 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
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
Benefits
Compensation: base salary is expected to be $130-170K depending on experience, with additional bonus compensation, equity compensation, and benefits.