Senior Manufacturing Associate

The Senior 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.

• 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 on third shift 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.

• Minimum of 5 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.