Work Location: Mercer County, New Jersey

Summary:

The DS Purification, Consultant role is responsible for hands-on execution and support of cGMP manufacturing operations, focusing on purification processes and ensuring compliance with regulatory standards. This position requires technical expertise, adaptability, and a commitment to continuous improvement in a dynamic manufacturing environment.

Responsibilities:

• Execute cGMP manufacturing activities, including following established procedures and supporting automated recipes to ensure reliable production.
• Perform Clean-In-Place (CIP) and Steam-In-Place (SIP) operations to maintain equipment and process integrity.
• Prepare, transfer, and filter buffers as part of the purification process, ensuring accuracy and compliance.
• Operate and clean chromatography and filtration systems, troubleshooting equipment and process issues as needed.
• Identify, report, and assist in the closure of deviations, contributing to a culture of compliance and quality improvement.
• Develop and optimize cGMP procedures to enhance operational efficiency and regulatory adherence.
• Collaborate effectively within and across diverse teams, proactively identifying and implementing continuous improvement opportunities.
• Maintain accurate documentation and communication, adapting to feedback and demonstrating a commitment to ongoing professional development.

Qualifications:

• Experience in cGMP manufacturing operations, preferably in purification or related bioprocessing roles.
• Strong verbal and written communication skills.
• Ability to work in a fast-paced, dynamic environment with competing priorities.
• Demonstrated collaboration skills within and between diverse groups.
• Proactive approach to identifying and implementing continuous improvement initiatives.
• Willingness to receive and incorporate feedback; passion for ongoing professional development is a plus.
• Aptitude for learning moderately complex technical systems.
• Physical ability to stand for 8-12 hours, lift up to 40 lbs, and perform repetitive motions, bending, stooping, and twisting.
• Comfortable working in varying temperatures and with hazardous materials and chemicals.
• Ability to work scheduled 40 hours per week, with overtime and any shift as needed.
• Compliance with gowning requirements and safety protocols in designated areas.

Published Category: Manufacturing & Technical Operations