Manager Continuous Improvement and Production Support

Sanofi•Pearl River, NY

8d•Onsite

About The Position

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.

Requirements

Bachelor's degree in biology, Biomedical Engineering, Mechanical Engineering, Biological Engineering, or related scientific discipline
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

Nice To Haves

Master's degree preferred
Experience with Flublok or recombinant protein vaccine manufacturing
Experience with insect cell culture systems (e.g., Sf9, expresSF+)
Lean Six Sigma certification or equivalent continuous improvement training

Responsibilities

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