Manager Continuous Improvement and Production Support

Job Title

Manager Continuous Improvement and Production Support

Pearl River, NY

This combination technical‑leadership role combines hands‑on expertise in biologics manufacturing with strategic team management to drive operational excellence across our Flublok production processes. You will lead a team of Subject Matter Experts while providing direct technical oversight of upstream and downstream operations, ensuring GMP compliance, and spearheading continuous improvement initiatives that enhance process efficiency, yield, and quality. The ideal candidate thrives in a fast‑paced, regulated environment where technical problem‑solving meets people development, and where your leadership directly impacts our mission to deliver life‑saving healthcare solutions to patients worldwide.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

• Lead, mentor, and develop a team of Subject Matter Experts across upstream and downstream manufacturing operations
• Manage a Continuous Improvement team focused on process optimization and operational excellence
• Coach team members on troubleshooting strategies, root cause analysis methodologies, and process improvement techniques
• Foster a culture of collaboration, accountability, and continuous learning

• Provide technical leadership and hands‑on support for Flublok drug substance manufacturing processes
• Oversee upstream operations including cell scale‑up, media preparation, and protein production
• Oversee downstream operations including purification and buffer preparation
• Ensure all manufacturing activities comply with GMP regulations and internal quality standards
• Serve as a technical resource for complex process troubleshooting and deviation investigations

• Drive continuous improvement initiatives to enhance process efficiency, yield, and quality
• Open, author, and drive change controls through completion in accordance with quality systems
• Lead root cause analysis investigations using structured methodologies (e.g., 5 Whys, Fishbone, FMEA)
• Identify and implement process improvements and efficiency gains across manufacturing operations

• Draft, review, and approve technical documents including SOPs, batch records, protocols, and reports
• Ensure documentation practices meet GMP and regulatory requirements
• Support regulatory inspections and audits as needed

• Bachelor's degree in biology, biomedical engineering, mechanical engineering, biological engineering, or related scientific discipline
• Master's degree preferred
• 7+ years of experience in biopharmaceutical manufacturing or process development, with demonstrated hands‑on expertise in upstream operations (cell growth and scale‑up), downstream operations (purification and buffer preparation), and analytical techniques such as chromatography.
• Minimum 3+ years of people management experience.
• Demonstrated experience in pharmaceutical GMP manufacturing environments.

• Process development experience in biologics manufacturing
• Strong background in root cause analysis and structured problem‑solving methodologies
• Single‑Use Technology (SUT) systems and operations
• Gas chromatography and analytical techniques
• Media preparation and buffer preparation
• Protein production processes
• Cell culture and cell scale‑up operations
• Upstream and/or downstream biologics manufacturing

• Proven ability to lead, coach, and develop high‑performing teams
• Strong change control management experience
• Excellent written and verbal communication skills
• Ability to balance strategic leadership with hands‑on technical support
• Strong organizational and project management skills
• Collaborative mindset with ability to work cross‑functionally

• Experience with Flublok or recombinant…