Downstream Process Scientist

About the role

Eurofins Scientific is a global life sciences leader with 58,000 staff across 900 laboratories in over 54 countries, providing analytical testing services across food, environment, pharmaceutical, cosmetic, genomics, and clinical diagnostics. This position focuses on downstream purification process development for biologics, vaccines, cell therapies, and other biopharmaceutical products at the Malvern, PA site.

Responsibilities

• Perform purification method development, optimization, and scale-up using Protein A, cation exchange, anion exchange, and ultrafiltration/diafiltration (UF/DF) methods.
• 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, 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, 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.
• Operate AKTA Avant systems, including troubleshooting, overseeing preventative maintenance, and scheduling emergent vendor repairs.
• Plan and organize materials for purification experiments, including buffer ordering, column packing, and setup of necessary materials.
• Lead technology transfer and scale-up efforts, preparing clear transfer packages and supporting manufacturing start-ups.

Qualifications

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

Schedule

Full-time, Monday–Friday, 8:00 a.m. – 5:00 p.m.; candidates currently living within a commutable distance of Malvern, PA are encouraged to apply.

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays