Manage multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of the organization. Manages/develops people and processes day-to-day activities, responsible for maintaining an environment of Safety, Quality, and productivity. Maintain an area based on the Sanofi values and code of ethics.
Assures that operation are conducted in compliance with plant procedures and regulatory agencies (i.e. cGMPs, CBER, WHO, EP et.al).
Supervises activities including cGMP manufacturing campaigns, scheduling, logistics, document creation, and review.
Using expert knowledge in aseptic processing practices, supervises and coaches staff to assure best practices are followed. Able to maintain aseptic gowning certification is a must.
Reviews batch records for correctness and completeness.
Participates in the planning and development of production schedules, coordinating personnel activities for commercial product and tech transfers.
Define and ensure adherence to the monthly production schedule for the process area including the ability to drive enhancements/improvements necessary to improve capacity utilization.
Consistently meets production, quality, compliance, financial and EH&S goals and objectives.
Manage a team operating an equipment asset base of diverse technologies / technical expertise including lyophilization, high-speed filling, and complex biological formulations.
Exhibit a strong sense of overall business ownership by determining the operational impacts caused by production issues and defining mitigation plans both within own scope of responsibility and with other functional groups to minimize customer impacts.
Exhibit a forward-looking view to Define, Measure, Analyze, Improve, and Control process improvements within their application process area including direct management of initiatives or supporting indirectly.
Ensures that all projects impacting the shop floor are executed properly, attaining desired outcomes on schedule and meeting quality standards.
Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e.g., IOC, AIOC, staff meetings). When necessary, coordinates Maintenance, Metrology, and Validation activities with applicable leaders. Takes a role in implementing new equipment and procedures.
HSD or equivalent
Minimum of seven (7) years of relevant experience in manufacturing, Quality Control, or Process Development in a cGMP environment.
Must be willing to work an off-shift schedule.
BS degree in Biological Science, Physical Science or Engineering (Chem, Mech, Electric)
Minimum of three (3) years of leadership experience.
Minimum of five (5) years of operations experience.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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