Lead Downstream Bioprocess Scientist

University of Delaware; Town of Newark (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

University of Delaware is seeking a Downstream Operations Scientist to lead purification unit operations within NIIMBL’s continuous mAb purification program. The role collaborates with bioreactor and analytical teams and applies 21CFR58 GxP guidelines to ensure high-quality product and robust data capture.

You will evaluate new technologies, set up and optimize downstream processes, and drive DoE studies to understand impurity levels, recovery, and activity.

Qualifications

• A Masters and 5+ years or PhD and 2+ years in chemical engineering or relevant life science discipline.
• Industrially relevant downstream purification experience is required with preference for experience in a 21CFR58-compliant GxP environment.
• Hands-on experience with a range of downstream unit operations and control systems, experience with DeltaV preferred.
• Operates chromatography skids and other bioprocess equipment for purification of industrially relevant materials.
• Knowledge of biotech manufacturing process and equipment including depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations.
• Possess a contribution mindset fueled by an inner drive to take initiative without being directed.
• Excellent interpersonal and managing skills with the desire to work collaboratively and effectively in a team environment.
• Ability to demonstrate effective leadership through communication, respect, influence, persuasion, and trust.
• Excellent problem solving and critical thinking skills.
• Excellent writing, communication, and presentation skills.
• Strong MS Excel, PowerPoint, and Word skills. Microsoft Project skills.
• Excellent organization and planning skills.
• Strong attention to detail and ability to adhere to standards procedures.
• Ability to function in a rapidly changing environment.

Responsibilities

• Demonstrate NIIMBL’s Core Values in daily conduct and ensures all decisions, actions, and teamwork practices align with the organization’s Business Principles.
• Serve as a lead technical scientist on multiple projects involving downstream purification unit operations for the manufacture of industrially relevant products and related activities.
• Evaluate and introduce new technologies and analytical tools to existing processes.
• Adhere to 21CFR58 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 column chromatography (e.g., ProA, SEC, CEX, AEX), filtration, TFF, and bulk filling.
• Develop new filtration unit operations such as tangential‑flow filtration (TFF), virus filtration, and depth filtration.
• Develop new chromatography unit operations, from screening and characterization to optimization and initial scale‑up.
• Optimize buffer compositions to improve the stability and solubility of target molecules.
• Collaborate with an analytical team to adapt and troubleshoot research analytical methods such as HPLC, SDS‑PAGE, enzyme activity and endotoxin assays to quantify yield, activity, and purity at various stages of the manufacturing process.
• Document all work and analyses in an electronic lab notebook. Perform tracking and trend analysis of method performance.
• Analyze process performance trends, perform statistical data analysis, and present data to teams.
• Partner with Informatics Infrastructure team on deploying structured data capture systems.
• Draft and revise SOPs and batch records.
• Maintain detailed documentation of lab activities and tabulation of data.
• Compile data generated to present and discuss at team meetings.
• Author, review and edit technical reports and manuscripts intended for publication.
• Stay current with relevant technologies and scientific literature.
• Perform other job‑related duties as assigned.

Skills

Downstream purification

Leadership

Communication

Problem solving

Teamwork

Education

Master's degree in chemical engineering or life sciences

PhD in a related field

Tools

DeltaV

MS Excel

PowerPoint

Word

MS Project

Job description

University of Delaware is seeking a Downstream Operations Scientist to lead purification unit operations within NIIMBL’s continuous mAb purification program. The role collaborates with bioreactor and analytical teams and applies 21CFR58 GxP guidelines to ensure high-quality product and robust data capture.

You will evaluate new technologies, set up and optimize downstream processes, and drive DoE studies to understand impurity levels, recovery, and activity.