Associate Principal Scientist, Biologics Drug Substance Commercialization (Associate Director)

Associate Principal Scientist (Associate Director) role providing technical and scientific leadership for late-stage and commercial biologics purification. You will design, scale, and transfer purification processes to ensure safe, consistent biological drug substance manufacturing in compliance with regulatory requirements.

• Participate in and/or spearhead cross-divisional technical teams for late-stage process development, characterization, and technology transfer of biopharmaceutical drug substance processes
• Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization
• Design experiments, analyze data, and mentor junior staff
• Provide technical leadership interpreting trends from commercial process monitoring and drive investigations/process improvements
• Author regulatory and technical documentation to ensure process alignment

Focus on downstream purification process development, scale-up, and technology transfer for biopharmaceutical drug substance manufacturing. Responsibilities include laboratory- and manufacturing-scale studies, supporting commercial process validation and characterization, interpreting process monitoring trends, and authoring regulatory/technical documentation.

The ideal candidate is an experienced biopharmaceutical purification scientist (10+ years) who has led technology transfer and scale-up of biologics manufacturing processes from late-stage development into reliable manufacturing. They are strong in chromatography and filtration systems, have authored regulatory/technical documentation, and can mentor junior staff while collaborating across process development, manufacturing, quality, and regulatory teams.