Associate Scientist – Downstream, Biologics Drug Substance Commercialization

• Execute hands-on experiments in biologics downstream processing
• Perform lab-scale process characterization
• Perform 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 support 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
• Experience executing lab activities, including authoring study protocols, planning and performing experiments, performing data analysis, and writing technical reports
• Ability to execute experiments independently while meeting quality and timeline expectations
• Well-developed communication, organizational, and problem-solving skills, with attention to detail
• Preferred:
  Experience with downstream processing of monoclonal antibody products or similar products
• Preferred:
  Experience with membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance
• Preferred:
  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
• No visa sponsorship
• US and Puerto Rico residents only

Demonstrates expertise in biologics downstream processing, including lab-scale and pilot-scale process development, while ensuring compliance with cGMP standards. Proficient in authoring technical documentation and collaborating with cross-functional teams to support drug substance manufacturing.

• Biologics Downstream Processing
• Process Characterization
• Technical Documentation Authoring
• Current Good Manufacturing Practice (cGMP)
• Membrane Filtration

• Process Scale-Up/Scale-Down Models
• Data Analysis
• Technical Report Writing
• Experimental Planning
• Viral Clearance

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

• Process Performance Qualification (PPQ)
• Large Molecule Drug Substance Technology Transfer
• Regulatory Submissions

• Preparative Chromatography
• Ultrafiltration
• Tangential Flow Filtration