Senior Scientist, Process Development

Your Contribution

• Develop and qualify scale-down models for downstream purification processes to support monoclonal antibody manufacturing
• Execute studies and FMEA assessments to establish critical process parameters and proven acceptable ranges for process characterization
• Lead development, optimization, and characterization of downstream processes, including scale-up, virus/impurity clearance, and resin/membrane lifetime
• Conduct downstream process unit operations such as depth filtration, chromatography, viral inactivation, viral filtration, tangential flow filtration, and formulation
• Collaborate with cross-functional teams to design experiments, analyze results, support technology transfers, and meet project timelines
• Contribute to CMC documentation by drafting process descriptions, characterization reports, QbD risk assessments, and other technical reports
• Drive the creation of best practices and workflows for process development in a fast-paced environment

A Good Match

• PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related discipline with 6+ years of relevant experience (including post-doctoral training), or MS with 8+ years of industry experience
• 6 years' experience in global pharma PD or MS&T for monoclonal antibodies or related biologics
• Expertise in downstream process development including scale-up and technology transfer
• Proven ability to design and execute process characterization studies using scale-down models that inform PPQ strategy
• Strong understanding of biologics CMC processes including PPQ/BLA readiness; antibody or ADC development preferred
• Demonstrated technical leadership within cross-functional teams and programs
• Willingness to travel domestically and internationally as required

Benefits

• Expected Pay Range: $113,600/year to $181,600/year + benefits, annual bonus & equity