Supervisor - cGMP Biomanufacturing (Downstream)

Position : 3rd Shift Supervisor – cGMP Biomanufacturing (Downstream)

Location: catalent madison WI

Client: Leading Biopharmaceutical Manufacturing Company

Shift: 3rd Shift / Night Shift

Duration : 3-6 MONTHS

Employment Type:

Position Overview

We are seeking an experienced 3rd Shift Supervisor – Downstream Biomanufacturing to lead and oversee manufacturing operations within a cGMP-regulated biologics production facility.

The selected candidate will supervise a team of approximately 5–15 employees and ensure the successful execution of downstream manufacturing activities, including chromatography, filtration, viral reduction, and bulk drug substance filling.

This role requires a strong background in biologics manufacturing, downstream processing, cGMP compliance, and team leadership. The supervisor will provide hands-on floor support, ensure production schedules are met, maintain quality standards, and promote a culture of safety, accountability, and continuous improvement.

Key Responsibilities

• Supervise and lead third-shift downstream biomanufacturing operations.
• Manage daily production activities and provide guidance to a team of approximately 5–15 employees.
• Oversee downstream processes, including column chromatography, normal flow filtration (NFF), tangential flow filtration (TFF), viral reduction/filtration, and bulk drug substance filling.
• Ensure all manufacturing activities are performed in accordance with cGMP guidelines, SOPs, batch records, and quality standards.
• Monitor production schedules, batch readiness, and manufacturing deliverables.
• Provide hands-on support to manufacturing employees and troubleshoot routine production challenges.
• Coach, train, and develop team members while promoting a right-first-time manufacturing culture.
• Coordinate with supervisors across other shifts to ensure consistent operations and effective shift handovers.
• Maintain accurate manufacturing documentation and ensure data integrity.
• Collaborate with Quality Assurance and other departments to address manufacturing and compliance-related issues.
• Support customer and Person-in-Plant (PIP) activities when required.
• Identify opportunities for process optimization, operational efficiency, and continuous improvement.
• Participate in employee hiring, performance evaluations, development planning, and other supervisory responsibilities.