Downstream Process Scientist

Eurofins•Malvern, PA

About The Position

The Downstream Process Scientist performs purification method development, optimization, and scale-up for biologics, vaccines, cell therapies, and other biopharmaceutical products. The work uses Protein A, cation- and anion-exchange purification, chromatography, filtration, ultrafiltration/diafiltration (UF/DF), and related technologies. The role includes designing process development, characterization, and scalability studies to improve product recovery, purity, yield, and manufacturing performance; analyzing and validating run data; identifying critical process parameters; and supporting technology transfer, process validation, and commercial manufacturing. The scientist documents laboratory work in real time using electronic lab notebooks and maintains records in accordance with GMP, GLP, and GDP expectations. The role also authors and reviews methods, technical reports, study protocols, SOPs, and validation documentation; uses Unicorn and electronic lab notebook systems; operates and troubleshoots ÄKTA Avant systems; oversees preventative maintenance and schedules vendor repairs; and plans experiment materials, including buffers and packed columns. The position leads technology transfer and scale-up efforts, prepares transfer packages, and supports manufacturing start-ups. This is a full-time position working Monday through Friday, 8 a.m. to 5 p.m. Candidates within commuting distance of Malvern, Pennsylvania are encouraged to apply.

Requirements

Bachelor's or master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related scientific discipline.
Knowledge of GMP-regulated manufacturing, quality systems, and bioprocessing best practices.
Demonstrated experience in downstream processing, purification sciences, bioprocess development, biopharmaceutical manufacturing, or a related laboratory environment is highly preferred.

Nice To Haves

Specialized training or certification in chromatography operations, bioprocess engineering, purification technologies, single-use manufacturing systems, or downstream process development.
Experience in GMP- and GLP-regulated environments and familiarity with biopharmaceutical quality systems.
Knowledge of downstream unit operations, including chromatography, filtration, UF/DF, buffer preparation, and process characterization.
Experience using electronic lab notebooks for data acquisition, following SOPs, and validating reports.

Responsibilities

Perform purification method development, optimization, and scale-up using Protein A, cation-exchange, anion-exchange, and ultrafiltration/diafiltration methods.
Develop, optimize, and scale downstream purification processes for biologics, vaccines, cell therapies, and other biopharmaceutical products using chromatography, filtration, UF/DF, and related technologies.
Design and execute process development, characterization, and scalability studies to improve product recovery, purity, yield, and manufacturing performance.
Process, analyze, and validate data generated by purification runs.
Analyze experimental data to identify critical process parameters, support process understanding, and contribute to technology transfer, process validation, and commercial manufacturing.
Document laboratory work in real time using electronic lab notebooks and maintain accurate records in accordance with GMP, GLP, and GDP expectations.
Author and review methods, technical reports, study protocols, SOPs, and validation documentation while maintaining quality and regulatory compliance.
Use laboratory systems, including Unicorn and electronic lab notebooks, to capture and manage purification activities.
Operate and troubleshoot ÄKTA Avant systems, oversee preventative maintenance, and schedule emergent vendor repairs.
Plan and organize materials for purification experiments, including ordering buffers, packing columns, and preparing required materials.
Lead technology transfer and scale-up efforts, prepare transfer packages, and support manufacturing start-ups.