Director Business Systems Biologics Manufacturing US - ...

Who You Are: You will provide central coordination and support for all Biologics platforms for costs, headcount and resources allocation, cycle time to formulation, prioritization of release of drug substances to the formulation, and all business systems related topics such as but not limited to SAP (BOMs, Process Orders, ) LIMS, Phenix for deviations, emergency change controls, and AFFMs, and 0-12 weeks execution. You will be the main interface between Biologics Manufacturing and various support functions across the site. This includes interactions with supply chain, finance, regulatory, manufacturing excellence, materials management, quality organization, planning, procurement, HSE, PQMR, and VIA Training. Provides leadership/oversight and is accountable for the flow of materials from the Bulk Biologics focus factory through formulation ensuring that production schedules are achieved and respected while ensuring the accuracy of SAP data to maintain the expected quality of Production and Financial planning. Tracks and reports on all biological yields provide analysis for drug substances capacity and capability planning, including generation of inputs for yearly budgets as well as long-range planning over a 5-year horizon. You will define and execute the staffing strategy and supervises all labor-related transactions for the whole Biologics department: RHC, TPWs, and APH budgeting, actuals tracking, resources allocation recommendation across Biologics platforms, development and implementation of flex plans between production areas, implementation of the specific flu staffing model, onboarding of all new hires (internals as well as TPWs). Responsible for developing and managing personnel of the Business Systems platform. Represents Biologics Manufacturing on key committees such as capability review, supply review, and convergence. The Team: The Business Systems group is part of the Biologics Manufacturing Platform within Vaccines Industrial Affairs US. Business Systems is responsible for all Financial and ERP (SAP) related processes in the Platform. This includes maintenance and accuracy of bills of materials and yields, oversight of transaction accuracy and timeliness, headcount management, planning/scheduling and all associated data analytics. The function is also responsible for providing data analytics that are used to monitor and drive performance on financials, yields and labor utilization to enable top decile performance and productivity relative to our peers. The Biologics Platform consists of six Manufacturing Buildings plus administrative space with approximately 700 full time employees and 300 contractors/temporary workers and is responsible for delivering drug substance for multiple vaccine based products that are shipped globally. Business systems provides support with a staff of approximately 13 team members. Vaccines US is comprised of multiple sites and over 2000 employees. Job Highlights: Safety Ensure business systems'' platform and team members act in compliance with health, safety, and environmental regulations. Quality Ensure all transactions are conducted in compliance with cGMPs and that all personnel is trained. Responsible for investigating and correcting deviations or departures from expected performance levels. Provide leadership and direction to ensure deviations, change controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality. Delivery Provides leadership, direction, and overall oversight for the business systems team in biologics manufacturing. Long and short term detailed capacity and capability planning for bacterial products Diphtheria Toxoid manufacturing (B46), Meninge Polysacharide manufacturing (B56), Meninge Conjugate manufacturing ( B56), MenQuad TT manufacturing (B56), viral products Flu concentrate manufacturing (B37, B59, B79) and Yellow Fever concentrate manufacturing (B14), Seed manufacturing (B46 and B59), and Flu Service/Re-agent production (B37, B46, B56, B59, B79). Tracks and reports metrics reflecting area performance (Yields, write-offs, budget, overtime) through the use of dashboards. Development of achievable production schedules taking into account product demands, equipment capability, and staffing constraints. Responsible for the 0-12 weeks execution, which includes scheduling, SAP Pos creation, BPRs coordination, and ensuring raw materials and disposables are available on time. Ensure that the priorities of the supply plan are accurately reflected and executed at the operational level. Managing the ''shop-floor'' control functions including tracking the flow of product through the Bulk manufacturing processes including transversal elements (Raw Material availability, Quality Control testing, and Batch release). Work transversally to reduce cycle time and ensure drug Substances are released for formulation ahead of needs. Biologics manufacturing representative for Menactra, Influenza, Yellow Fever convergence teams. Cost Manage and provide performance updates on a regular basis utilizing performance dashboards. Provides metrics for capability review, supply review, and +QDCI boards for biologics platform and site where required. Cooperates transversally with area leads on yield performance along with projecting out across the horizon to understand the financial impact. Responsible for managing dashboards related to financial performance for biologics. Works closely with finance to review actuals versus budget for such areas as process order variance, write-offs, budget performance with a focus on controllable cost, corrective and preventative actions where necessary, along with providing a monthly report for the biologics platform. Ensure dashboards are available for the shop floor and provide training and updates on a regular basis. Interface with materials management, purchasing, procurement, QC, finance, manufacturing excellence, and others as appropriate to ensure that the needs of the factory are understood and met by external stakeholders. Drives key initiatives for the biologics platform such as cost, and saving initiatives, and tracks success for the organization while leading key strategic plans within biologics manufacturing. Involvement/ People Responsible for building and maintaining a high-performing Business Systems team, providing effective alignment and communication. Ensures that People Management is actively performed in Business Systems, with monthly 1-1 meetings, constant feedback, development, and coaching conversations for employees of the platforms. Manages all labor aspects for Biologics: RHC, TPWs, and APH budgeting, actuals tracking, resources allocation recommendation across Biologics platforms, development and implementation of flex plans between production areas, implementation of the specific flu staffing model, onboarding of all new hires (internals as well as TPWs). CONTEXT OF THE JOB/MAJOR CHALLENGES Strong leadership and technical/expertise skills are required to lead business systems. Able to communicate and cooperate transversally within and outside the biologics manufacturing boundaries. Able to serve as a change agent and think strategically to drive business to the next level. Ability to function independently and act as a voice of the biologics team. DIMENSIONS/SCOPE Biologics Manufacturing: The Biologics platform manufactures all Antigens required for Fluzone, Menactra, and Yellow Fever vaccines, supporting a US$ 2+ billion portfolio. HEADCOUNT: Supports headcount related activities (hiring and flexing) for the Biologics group (~700 internal employees and ~ 300 temporary workers) Direct reporting approximately 5-7 people KEY INDICATORS Biologics Financial performance vs budget Headcount actuals vs Budget target Yields Influenza campaigns readiness Basic Qualifications Bachelor''s degree in business, Life Science or engineering 5-10 years of experience in a Pharmaceutical management-related role and as a people champion. Manufacturing management experience for part of the 5-10 years is a must. 3-5 years'' experience of business systems such as SAP, Phenix, LIMS, scheduling, and data analysis. Preferred Qualifications: Experience in drug substances/biologics manufacturing is highly preferred. MBA or LEAN is a plus APICS/CPIM knowledge/certification preferred The Fine Print: Travel: Less than 10% Remote Work: 1 day week flex remote available but is always subject to change depending on business activates 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. According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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 LI-SP 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. This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.

Created: 2025-10-04