Downstream Operations Scientist

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.
• 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 bioprocessing equipment for purification of industrially relevant materials.
• 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.
• Able 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 standard procedures.
• Able to function in a rapidly changing environment.