Downstream Operations Scientist

Pay Grade: 33E

Context of the Job:

NIIMBL (the National Institute for Innovation in Manufacturing Biopharmaceuticals) is the largest industry-led public-private partnership dedicated to biopharmaceutical manufacturing innovation with participation from well-over 200 companies, government agencies, and other partners collectively innovating manufacturing approaches. As part of these activities, NIIMBL is home to a technical operations team that works collaboratively with scientists from across the biopharmaceutical manufacturing industry including manufacturers, suppliers, and government agencies. The Downstream Operations Scientist is responsible for leading downstream purification unit operations in NIIMBL’s continuous mAb purification process that is part of a Process Intensification program. The work will involve 21CFR58 compliant downstream operations and data analysis, including utilizing automation systems. The scientist will also collaborate with bioreactor specialists and an analytical team, and have access to state-of-the-art knowledge from across the industry and government in guiding the work.

NIIMBL’s extensive portfolio of research, development, demonstration, and innovation activities is funded by federal, private, state, and other sources with the parent sponsoring government agency being the National Institute of Standards and Technology (NIST). NIIMBL is also a member of the Manufacturing USA network of institutes, a multi-billion dollar investment by the federal government to advance United States competitiveness in advanced manufacturing innovation. Institutionally at the University of Delaware, NIIMBL reports to the Vice President for Research, Scholarship & Innovation.

Among other activities, NIIMBL executes technical projects that advance the readiness levels of relevant technologies, assays, and methods. The scopes of scientific projects generally include many organizations as partners and collaborators such as scientists from several large and small companies, a scientist from a federal agency, and a scientist from a university. Many of these projects will be hosted at the University of Delaware in a state-of-the-art laboratory facility purpose-built for such studies. These projects will involve a diverse set of technologies and approaches and address drug substance, drug product, and analytical needs by the industry appropriate to several types of biopharmaceuticals: therapeutic antibodies and proteins , gene therapy vectors, vaccines, antibody-drug conjugates, bispecific antibodies, and cell therapies, among others.

Major 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.

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.