- 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.