Bachelor's or Master's Degree in a relevant scientific discipline.
Experience in downstream processing and biopharmaceutical manufacturing preferred.
Knowledge of GMP-regulated manufacturing and quality systems required.
Specialized training in chromatography or bioprocess engineering is a plus.
Familiarity with biopharmaceutical quality systems and eLNs is advantageous.
Responsibilities
Perform purification method development and optimization for biopharmaceutical products.
Analyze and validate data from purification runs to ensure process efficiency.
Design and execute studies to enhance product recovery and purity.
Document laboratory work in compliance with GMP, GLP, and GDP standards.
Lead technology transfer and scale-up efforts for manufacturing.
Utilize laboratory software to manage purification activities effectively.
Plan and organize materials for purification experiments.
Benefits
Comprehensive medical coverage including dental and vision options.
Life and disability insurance provided.
401(k) plan with company matching contributions.
Paid vacation and holidays offered.
Full Job Description
Job Description
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.
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
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.
Additional Information
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
About Eurofins Lancaster Laboratories
Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
