Pay Grade: 33E

Context of the Job:

The Downstream Operations Scientist is responsible for leading downstream purification unit operations for materials from bioreactors and shake flasks with culture volumes ranging from 250mL to 50L in scale at the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). 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.

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: vaccines, therapeutic proteins and antibodies, antibody-drug conjugates, bispecific antibodies, gene therapy vectors, and cell therapies, among others.

Major Responsibilities

• Serve as a lead technical scientist on multiple projects involving downstream purification unit operations for the manufacture of industrially relevant products and related activities.
• 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 primary recovery unit operations such as centrifugation, homogenization, flocculation, tangential-flow filtration (TFF), 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 in chemical engineering or relevant life science discipline and 5 years of industrially relevant downstream purification experience is required with preference for experience in a 21CFR58-compliant GxP environment, or a PhD in chemical engineering or relevant life science discipline and 2 years of 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 cell culture, 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.