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.

Qualifications

• 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.