Manager, Manufacturing

Role Overview

Responsible for ownership, execution, and governance of Manufacturing risk assessments and change controls. Provides leadership to ensure risk-based decision making, compliant execution of changes, and timely support of manufacturing operations while maintaining alignment with cGMP and regulatory expectations.

What You Will Do

Plans, executes, and tracks Manufacturing risk assessments and manufacturing-driven change controls in coordination with cross-functional departments, internally or externally. Oversees and contributes to the completion of technical and operational activities related to Manufacturing risk assessments and change controls.

Why It Might Be a Fit

Requires strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of applicable regulatory requirements and guidance documents. Demonstrates ability to provide solutions to moderately complex to semi-routine problems and excellent verbal, written, and interpersonal communication skills.

Requirements

• 7+ years of relevant experience with a BS or BA preferred
• 5+ years of relevant experience with an MS preferred
• Prior experience in a cGMP-related industry is required; biopharmaceutical or pharmaceutical manufacturing experience preferred

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• paid time off
• discretionary annual bonus
• discretionary stock-based long-term incentives
• benefits package