About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
About the job
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.
Job Purpose:
Lead the ampoule manufacturing team to meet the provided production plan and assure complying of the process to the cGMP rules.
Responsibilities and Tasks:
Manufacturing and packaging operations in ampoule area.
Oversee daily production operations and ensure compliance with GMP (Good Manufacturing Practice) standards.Monitor and optimize manufacturing efficiency while maintaining product quality.Follow SOPs (Standard Operating Procedures) and maintain proper documentation.Maintain accurate production records and documentation.Create and update batch documentation for sterile products.Make decisions on batch disposition in collaboration with Quality Assurance.Ensure proper gowning and aseptic behavior of all personnel in the sterile area.Ensure all critical parameters are met during manufacturing operations.Oversee and train production staff on sterile techniques and GMP requirements.Manage clean room classifications and maintain sterile conditions.Develop and maintain defect libraries and classification systems.Ensure consistent application of defect criteria across all inspectorsOversee the maintenance and qualification of manual inspection processTroubleshoot production issues and propose solutions.Maintain compliance to local and Sanofi regulations in sterile manufacturing and packaging areas.New Ampoule projects area:
Participate in validation and qualification activities for new line (IMA line, Fedegari autoclaves, Cleaning, Process,…etc)Create SOPs for new ampoule area.Other duties:Support internal and external auditsCollaborate with cross-functional teams (Quality, Supply Chain, Engineering)Support regulatory requirements and documentation.Participate in multidisciplinary teams for problem-solving and continuous improvementHSE and Energy Role:-
Communicate information shared by the HSE teamShare best practices.Monitor team HSE dashboard (KPIs of the area), ensure a global overview & consolidation (for example: track deployment of HSE programs, actions, events, investigations, inspections, trainings, risk assessment).Propose improvements.Promote HSE weak signals collection.Raise and alert if needed to concerned manager and/or to HSE team.Support managers on HSE topics.Organize immediate GEMBA in case of event involving the right people.Support/lead HSE investigations.Coordinate local drills.Coordinate coactivity in the area and associated GEMBAs.Maintain up to date chemical lists for the department & SMDS accessCoordinate general HSE onboarding for newcomersFacilitate coordination of MSV in the areaAttend HSE champions network meetingSupport the HSE trainings on the shopfloorAbout you
Education: Bachelor’s degree in pharmacyRelated Experience: 2+ years of experience in the production / Microbiology / sterility assurance.Soft skills:Good communication & Presentation skills.Planning & organizing skills.Problem solving skills.Decision making skillsReport writing skills.Ability to co-ordinate several inter-departmental activities.Good command of MS word, Excel & Power Point.Technical Skills: GMP (Good manufacturing practices)Aseptic processing / Terminal sterilization / Microbiology / contamination controlGDP (Good Documentation practices)Veeva VaultSAP AthenaWhy choose us?
Help shape the future of care for chronic and complex conditions like diabetes and cardiovascular disease - and make a real impact at scale, with medicines that reach over 100 million people each year.Lead a high-impact portfolio with bold ambitions and significant upcoming launches.Drive meaningful change in a streamlined, AI-powered organization that values smart, modern ways of working.Expand your leadership impact through cross-functional collaboration and international career paths.Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!