Manager Continuous Improvement and Production Support

Location: Pearl River

## Manager Continuous Improvement and Production Support Bewerbenlocations:
Pearl River, NYtime type:
Vollzeitposted on:
Gestern ausgeschriebentime left to apply:
Enddatum: 30. Juni 2026 (Noch 19 Tage Zeit für Bewerbung) job requisition :
R2851149
** Job Title**:
Manager Continuous Improvement and Production Support

* Location:

Pearl River, NY
** About the Job
** 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.
** About Sanofi:
** 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.
** Main Responsibilities
**** Team Leadership & Development:
*** 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
** Manufacturing Operations & Technical Oversight:
*** 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
** Continuous Improvement & Change Management:
*** 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
** Documentation & Compliance:
*** 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
** About You
**** Basic Qualifications
*** 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.
** Technical

Skills:

*** 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
** Soft Skills
*** Proven ability to lead, coach, and…