Lead Downstream Bioprocess Scientist (Purification)

The Chronicle Of Higher Education, Inc.; Newark (DE); On-site; USD 75,000 - 110,000; Full time

Job summary

The University of Delaware is seeking a Downstream Operations Scientist to lead downstream purification unit operations for materials from bioreactors and shake flasks within NIIMBL. This role supports NBC biopharmaceutical workflow at Newark, DE, and involves 21 CFR 58 compliant processes and data analysis in a modern laboratory.

Responsibilities include developing purification and formulation steps, DoE studies, process parameter optimization, and collaboration with bioreactor and analytics

Qualifications

• Masters in chemical engineering with 5 years of industrially relevant downstream purification experience; PhD with 2 years acceptable.
• Experience in a 21CFR58-compliant GxP environment preferred.
• Hands-on experience with chromatography skids and bioprocess equipment.
• Knowledge of biotech manufacturing processes and equipment.
• Strong writing, communication and collaboration skills.

Responsibilities

• Lead downstream purification unit operations for biopharmaceuticals.
• Adhere to 21 CFR 58 GxP guidelines in execution of work.
• Set-up, operate, troubleshoot, maintain, and clean downstream bioprocessing equipment.
• Use manufacturing experience to identify process parameters and define their setpoints.
• Perform DoE studies to confirm the impact of process parameters on impurity levels, product recovery, and potency.
• Characterize performance of existing purification and formulation unit operations, including chromatography, filtration, TFF and bulk filling.
• Develop new primary recovery and chromatography unit operations for scale-up.
• Collaborate with analytical team to adapt methods such as HPLC, SDS-PAGE, enzyme activity and endotoxin assays.
• Document all work in electronic lab notebook and perform tracking and trend analysis.
• Draft and revise SOPs and batch records.

Skills

Downstream purification

Chromatography

Process development

DoE studies

Data analysis

GxP compliance

DeltaV control system

Education

Master of Science in Chemical Engineering

PhD in Chemical Engineering

Tools

DeltaV control system

Job description

The University of Delaware is seeking a Downstream Operations Scientist to lead downstream purification unit operations for materials from bioreactors and shake flasks within NIIMBL. This role supports NBC biopharmaceutical workflow at Newark, DE, and involves 21 CFR 58 compliant processes and data analysis in a modern laboratory.

Responsibilities include developing purification and formulation steps, DoE studies, process parameter optimization, and collaboration with bioreactor and analytics