Downstream Operations Scientist

Apply now Job no: 502528
College / VP Area: Research Office
Work type: Staff
Location: Newark, DE
Categories: Research & Laboratory

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 21

CFR
58 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.

NIIMBL is a large-scale effort dedicated to supporting the manufacturing of biopharmaceuticals, and it is established by a cooperative agreement with the National Institute of Standards and Technology (NIST) as a public/private consortium of a diverse set of member organizations, including industry, academia, non-profit organizations, state governments, and federal agencies. NIIMBL is a member of the Manufacturing USA network of institutes funded 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.

• 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 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 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…