Supervisor, Manufacturing - Downstream

Supervisor, Manufacturing - Downstream

Salary: $75,000 - $95,000

Position Summary

The Supervisor, Manufacturing - Downstream is responsible for leading downstream manufacturing operations and supervising production staff while actively participating in hands-on processing activities. This role ensures all production is carried out in full compliance with current Good Manufacturing Practices (cGMP) through direct floor presence, oversight, and continuous improvement of processes.

Key Responsibilities

• Supervise and lead downstream manufacturing staff to ensure safe, efficient, and compliant operations
• Schedule, plan, and coordinate daily production activities to meet operational goals
• Perform hands-on purification processes, including column chromatography, tangential flow filtration, nano-filtration, and aseptic bulk filling, as needed
• Ensure accurate and compliant cGMP documentation practices
• Initiate, revise, and review Batch Production Records (BPRs), Batch History Records (BHRs), SOPs, and associated forms
• Identify, investigate, and document deviations (IRs/DRs/CAPAs), and ensure timely implementation of corrective and preventive actions
• Develop and maintain SOPs to ensure compliance with regulatory requirements and internal standards
• Coordinate manufacturing, validation, and maintenance activities with cross-functional teams
• Support the implementation of new manufacturing processes and critical equipment
• Identify and resolve technical, procedural, and equipment-related issues impacting production and compliance
• Assist in technology transfer from Process Development to GMP Manufacturing
• Support investigations, inspections, and regulatory audits
• Promote and enforce safety standards; report unsafe conditions to EHS or leadership
• Manage and develop direct reports, providing guidance and escalating issues as needed
• Participate in continuous improvement initiatives and other duties as assigned

Minimum Qualifications

• Bachelor's degree in Biology, Biotechnology, Chemical Engineering, or related field, or equivalent combination of education and experience
• 3-5 years of cGMP downstream purification experience
• Minimum of 3 years of supervisory experience in downstream processing
• Proven ability to lead teams and drive efficient, compliant manufacturing operations

Preferred Qualifications

• Bachelor's degree in life sciences or a closely related discipline
• Demonstrated leadership in building and improving floor operations within a regulated manufacturing environment