Manager Continuous Improvement and Production Support
Job Title: Manager Continuous Improvement and Production SupportLocation: Pearl River, NYAbout The JobThis 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 SanofiWe 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 ResponsibilitiesTeam Leadership & Development:Lead, mentor, and develop a team of Subject Matter Experts across upstream and downstream manufacturing operationsManage a Continuous Improvement team focused on process optimization and operational excellenceCoach team members on troubleshooting strategies, root cause analysis methodologies, and process improvement techniquesFoster a culture of collaboration, accountability, and continuous learningManufacturing Operations & Technical OversightProvide technical leadership and hands-on support for Flublok drug substance manufacturing processesOversee upstream operations including cell scale-up, media preparation, and protein productionOversee downstream operations including purification and buffer preparationEnsure all manufacturing activities comply with GMP regulations and internal quality standardsServe as a technical resource for complex process troubleshooting and deviation investigationsContinuous Improvement & Change ManagementDrive continuous improvement initiatives to enhance process efficiency, yield, and qualityOpen, author, and drive change controls through completion in accordance with quality systemsLead root cause analysis investigations using structured methodologies (e.g., 5 Whys, Fishbone, FMEA)Identify and implement process improvements and efficiency gains across manufacturing operationsDocumentation & ComplianceDraft, review, and approve technical documents including SOPs, batch records, protocols, and reportsEnsure documentation practices meet GMP and regulatory requirementsSupport regulatory inspections and audits as neededAbout YouBasic QualificationsBachelor's degree in biology, Biomedical Engineering, Mechanical Engineering, Biological Engineering, or related scientific disciplineMaster's degree preferred7+ 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 SkillsProcess development experience in biologics manufacturingStrong background in root cause analysis and structured problem-solving methodologiesSingle Use Technology (SUT) systems and operationsGas chromatography and analytical techniquesMedia preparation and buffer preparationProtein production processesCell culture and cell scale-up operationsUpstream and/or downstream biologics manufacturingSoft SkillsProven ability to lead, coach, and develop high-performing teamsStrong change control management experienceExcellent written and verbal communication skillsAbility to balance strategic leadership with hands-on technical supportStrong organizational and project management skillsCollaborative mindset with ability to work cross-functionallyPreferred QualificationsExperience with Flublok or recombinant protein vaccine manufacturingExperience with insect cell culture systems (e.g., Sf9, expresSF+)Lean Six Sigma certification or equivalent continuous improvement trainingWhy choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scaleTransform lives worldwide by delivering life-changing treatments anywhere, anytime.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SP#vhdAll compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.