Scientist, Downstream – Biologics Drug Substance Commercialization

• Lead hands-on experiments in biologics downstream processing
• Perform lab-scale process characterization
• Conduct pilot-scale process development
• Develop process scale-up/scale-down models
• Collaborate with commercial manufacturing teams as a process sciences representative
• Support facility start-up and in-line activities
• Provide on-the-floor support for drug substance manufacturing as needed
• Author and/or review technical documents supporting Process Performance Qualification (PPQ) and licensure

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline
• 2+ years of experience with downstream processing of monoclonal antibody (mAb) products or similar products in a laboratory or manufacturing setting
• Experience with membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance
• Mechanistic understanding of downstream processing separation sciences
• Ability to execute experiments independently while meeting quality and timeline expectations
• Well-developed communication, organizational, and problem-solving skills, with attention to detail
• Large molecule drug substance technology transfer experience preferred
• Collaboration with analytical teams, pilot-scale, and/or manufacturing environments preferred
• Experience authoring technical documentation for process description, process characterization, process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions preferred
• Current Good Manufacturing Practice (cGMP) awareness or experience preferred
• No visa sponsorship
• 10% travel requirement

Demonstrates expertise in downstream processing of monoclonal antibodies, including hands-on experience with process characterization and scale-up models. Proficient in technical documentation and collaboration with manufacturing teams while adhering to cGMP standards.

• Downstream Processing of Monoclonal Antibodies
• Membrane Filtration
• Preparative Chromatography
• Technical Documentation Authoring
• Current Good Manufacturing Practice (cGMP) Awareness

• Downstream Processing
• Process Characterization
• Process Scale-Up/Scale-Down Models
• Viral Clearance
• Ultrafiltration
• Tangential Flow Filtration
• Mechanistic Understanding of Separation Sciences
• Process Performance Qualification (PPQ)
• Risk Assessment
• Control Strategy

• Communication Skills
• Organizational Skills
• Problem-Solving Skills
• Attention to Detail

• Biologics
• Drug Substance Manufacturing
• Technical Documents
• Technology Transfer
• Pilot-Scale Development