Downstream Operations Scientist

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.

• 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.