Mfg Operations Associate Director – Biologics, Drug Substance

Vrtx is seeking a Manufacturing Operations Associate Director – Biologics, Drug Substance to lead critical manufacturing operations at our Seattle, WA facility. This full-time role offers the opportunity to drive operational excellence, ensure regulatory compliance, and oversee the production of life-changing biologic therapeutics.

The Opportunity

As Manufacturing Operations Associate Director for biologics drug substance production, you'll oversee day-to-day manufacturing operations at our Seattle facility, where we produce the foundational molecules that enable breakthrough therapies. This leadership role combines strategic oversight with hands-on engagement in a highly regulated environment, where your decisions directly impact production quality, efficiency, and regulatory compliance. You'll collaborate with cross-functional teams to optimize processes, implement continuous improvements, and maintain the highest standards of pharmaceutical manufacturing excellence.

Your Responsibilities

• Lead and manage manufacturing operations teams responsible for biologics drug substance production
• Ensure full compliance with FDA regulations, current Good Manufacturing Practice (cGMP) standards, and company policies
• Monitor production schedules, resource allocation, and process efficiency to meet manufacturing targets
• Oversee quality assurance activities, including in-process testing and batch documentation review
• Identify opportunities for process optimization and implement continuous improvement initiatives
• Collaborate with regulatory affairs, quality assurance, and supply chain teams to support seamless operations
• Manage safety protocols and maintain a strong safety culture across all production areas
• Support strategic planning and capacity planning for biologics manufacturing

What You Bring

• Significant experience in pharmaceutical or biopharmaceutical manufacturing operations
• Demonstrated leadership experience managing cross-functional manufacturing teams
• Deep knowledge of biologics and drug substance manufacturing processes and equipment
• Strong understanding of FDA regulations and cGMP requirements
• Proven track record of process optimization and operational excellence
• Excellent communication and problem-solving skills in regulated environments
• Bachelor's degree in Chemistry, Chemical Engineering, Biology, or related field (or equivalent professional experience)

Why Join Vrtx

Vrtx is dedicated to discovering, developing, and commercializing innovative medicines for patients with serious diseases. Our Seattle manufacturing operations are central to this mission, producing drug substances that form the foundation of our therapeutic pipeline. As a member of our manufacturing leadership team, you'll contribute to meaningful work in a growth-focused environment that values operational excellence, safety, and continuous improvement.

Next Steps

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.