Downstream Process Scientist

Eurofins USA PSS Insourcing Solutions•Malvern, PA

16h

About The Position

The Downstream Process Scientist develops, optimizes, characterizes, and scales downstream purification processes for biologics, vaccines, cell therapies, and other biopharmaceutical products. The role uses chromatography, filtration, ultrafiltration/diafiltration (UF/DF), and related technologies to improve product recovery, purity, yield, and manufacturing performance. The scientist plans and executes purification studies, analyzes and validates run data, and identifies critical process parameters to build process understanding and support technology transfer, process validation, and commercial manufacturing. The position also leads technology transfer and scale-up efforts, prepares transfer packages, and supports manufacturing start-ups. The role documents laboratory work in real time using electronic lab notebooks and maintains accurate records in accordance with GMP, GLP, and GDP expectations. It authors and reviews methods, technical reports, study protocols, SOPs, and validation documentation while complying with applicable quality and regulatory requirements. The scientist uses Unicorn and electronic lab notebook systems, operates and troubleshoots AKTA Avant systems, oversees preventative maintenance, schedules vendor repairs, and organizes materials for purification experiments, including buffer ordering and column packing. This is a full-time position, Monday through Friday, 8 a.m. to 5 p.m. Candidates living 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.
Full-time availability, Monday through Friday, 8 a.m. to 5 p.m.

Nice To Haves

Demonstrated experience in downstream processing, purification sciences, bioprocess development, biopharmaceutical manufacturing, or related laboratory environments.
Specialized training or certification in chromatography operations, bioprocess engineering, purification technologies, single-use manufacturing systems, or downstream process development.
Experience working 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 laboratory notebooks for data acquisition, following SOPs, and validating reports.
Living within commuting distance of Malvern, Pennsylvania.

Responsibilities

Perform purification method development, optimization, and scale-up using techniques such as Protein A purification, cation exchange, anion exchange, and UF/DF.
Develop, optimize, and scale downstream purification processes for biologics, vaccines, cell therapies, and other biopharmaceutical products.
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; identify critical process parameters and support process understanding.
Contribute to technology transfer, process validation, and commercial manufacturing activities.
Lead technology transfer and scale-up efforts, prepare transfer packages, and support manufacturing start-ups.
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.
Use Unicorn and electronic lab notebook systems to capture, manage, and support purification activities.
Operate and troubleshoot AKTA Avant systems, oversee preventative maintenance, and schedule emergent vendor repairs.
Plan and organize materials for purification experiments, including ordering buffers, packing columns, and setting up necessary materials.