Manufacturing Associate

Job Summary

The Manufacturing Associate is responsible for supporting GMP manufacturing operations with a focus on cell culture processes, operational excellence, and compliance. This role requires a hands-on manufacturing professional who can work independently on third shift, support quality-related activities, and provide on-the-job training to manufacturing staff. The ideal candidate has extensive manufacturing experience, strong problem-solving skills, and the ability to ensure safe, efficient, and compliant production operations.

Responsibilities

• Perform manufacturing operations in accordance with GMP requirements, standard operating procedures (SOPs), and batch records.

• Execute cell culture processes and support routine manufacturing activities to ensure production goals are achieved.

• Work independently with minimal supervision while maintaining high standards of quality and compliance.

• Investigate and document manufacturing deviations and support Quality Management System (QMS) activities, including CAPA-related processes.

• Identify, troubleshoot, and resolve manufacturing issues to minimize downtime and maintain operational efficiency.

• Conduct on-the-job training for manufacturing personnel and ensure adherence to established procedures and best practices.

• Maintain accurate manufacturing documentation and ensure timely completion of production records.

• Collaborate with cross-functional teams, including Quality, Manufacturing, and Technical Operations, to support continuous improvement initiatives.

• Promote a safe working environment and ensure compliance with GMP, safety, and company policies.

Qualifications

• Minimum of 3 years of experience in manufacturing or manufacturing-adjacent roles within a regulated environment.

• Broad hands-on experience with cell culture manufacturing processes is strongly preferred.

• Experience with deviation investigations and Quality Management Systems (QMS), including CAPA processes, is highly preferred.

• Demonstrated ability to work independently with minimal oversight, particularly in an off-shift or third-shift manufacturing environment.

• Experience training and mentoring manufacturing personnel through on-the-job instruction is highly desirable.

• Strong understanding of GMP regulations, documentation practices, and manufacturing compliance requirements.

• Excellent communication, organizational, and problem-solving skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.