Downstream Process Scientist

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

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

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.