Downstream Process Scientist

Perform purification method development, optimization, and scale up activities using methods such as, Protein A Purification, Cation Exchange Purification, Anion Exchange Purification, Ultrafiltration / Diafiltration. Process, analyze, and validate data generated by purification runs. Develop, optimize, and scale downstream purification processes for biologics, vaccines, cell therapies, and other biopharmaceutical products using chromatography, filtration, ultrafiltration/diafiltration (UF/DF), and related purification technologies. Design and execute process development, characterization, and scalability studies to improve product recovery, purity, yield, and overall manufacturing performance. Analyze experimental data to identify critical process parameters, support process understanding, and contribute to technology transfer, process validation, and commercial manufacturing activities 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 and technical reports, study protocols, standard operating procedures (SOPs), and validation documentation while maintaining compliance with applicable quality and regulatory requirements. Use laboratory software and systems, including Unicorn and electronic lab notebooks, to capture, manage, and support purification activities. Proficient with operating AKTA Avant Systems including troubleshooting problems, overseeing preventative maintenance of the instrument, and scheduling emergent vendor repairs. Responsible for planning and organizing materials for executing purification experiments including but not limited to buffer ordering, column packing, setting up and organizing necessary materials Lead technology transfer and scale-up efforts, preparing clear transfer packages and supporting manufacturing start-ups. Bachelor's or Master’s Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, or related scientific discipline. Demonstrated experience in downstream processing, purification sciences, bioprocess development, biopharmaceutical manufacturing, or related laboratory environments highly preferred. Knowledge of GMP-regulated manufacturing, quality systems, and bioprocessing best practices required Preferred Experience: Specialized training or certification in chromatography operations, bioprocess engineering, purification technologies, single-use manufacturing systems, or downstream process development Experience working in Good Manufacturing Practice (GMP) and Good Laboratory Practices (GLP) regulated environments and familiarity with biopharmaceutical quality systems preferred. Knowledge of downstream unit operations, including chromatography, filtration, ultrafiltration/diafiltration (UF/DF), buffer preparation, and process characterization, preferred. Experience with utilizing eLNs for data acquisition, following SOPs and validating reports. Position is full-time, Monday-Friday, 8 a.m. - 5 p.m., Candidates currently living within a commutable distance of Malvern, PA are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.