Senior Associate Scientist, Downstream Process Development

Job Title - Senior Associate Scientist, Downstream Process Development Work Location - Cranbury NJ Job Summary 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. Job 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 departments or assigned other duties.

PhD in Life Sciences or related field, MS with 2+ years or BS with 4+ years of experience in a biopharmaceutical or biological contract testing/manufacturing organization. Demonstrated hands-on experience operating and troubleshooting downstream purification processes and equipment, including chromatography skids or systems, columns, TFF/UFDF systems, pumps, filters, tanks, mixers, single-use assemblies, and related process instrumentation. Pilot-scale or manufacturing-scale downstream processing experience is strongly preferred, including hands-on run execution, scale-up support, equipment preparation, buffer and material readiness, process monitoring, and coordination with manufacturing, pilot plant, analytical, and project teams. Strong oral & written communication skills are required. Ability to work effectively as part of a team and to exhibit effective interpersonal skills. Experience in a cGMP environment is highly desirable. Ability to take on multiple tasks simultaneously. Proficient in Microsoft (Excel, Word, Outlook) The anticipated salary for this position is $55,000 - $87,000 The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertis and company business needs.