Senior Associate Scientist, Downstream Process Development

About the role

This role is intended for an experienced, operations-focused Downstream Scientist who can independently plan, execute, and troubleshoot downstream purification activities in support of process development, scale-up, pilot production, technology transfer, and GMP manufacturing support. The Scientist must have strong hands-on experience with downstream unit operations, including chromatography, UF/DF, TFF, viral inactivation, depth filtration, sterile filtration, buffer preparation support, and equipment setup/operation. Pilot-scale downstream processing experience is strongly preferred. The role will serve as a key technical and operational contributor, working closely with PD, manufacturing, analytical, and project teams to ensure safe, compliant, and timely execution of downstream activities. Located in Cranbury, NJ.

Responsibilities

• Independently plans and executes hands-on downstream purification operations from bench scale to pilot scale, including chromatography, filtration, viral inactivation, UF/DF, TFF, and related process steps to support development, scale-up, and non-GMP material generation.
• Coordinates operational readiness for downstream runs, including equipment availability, column or membrane preparation, buffer and material readiness, batch record or protocol preparation, execution logistics, and communication with supporting functions.
• Provides real-time process monitoring, operational troubleshooting, and technical decision-making during downstream execution; identifies process, equipment, or material risks and proposes practical mitigation actions.
• Documents execution details, process observations, deviations, troubleshooting outcomes, and data analysis clearly and accurately in protocols, reports, batch records, logbooks, and other required documentation; supports training of cross-functional staff as needed.
• Supports technology transfer to GMP manufacturing by providing process understanding, operational guidance, run support, deviation assessment, investigation input, and practical recommendations for manufacturing execution.
• Serves as Downstream purification SMEs to participates in client calls and face to face meetings. Provides project plans and updates to clients.
• Authors Downstream lab equipment SOPs; maintains equipment functionality and coordinates repairs and preventative maintenance.
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics internal policies and guidelines.
• Completes all required training (i.e. safety, equipment etc.).
• Contributes to the overall operations and to the achievement of departmental goals.
• May be required to assist in other