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CMC Operational Planning & Capacity Manager

Company: Sanofi
Location: Framingham
Posted on: May 12, 2022

Job Description:

Job purpose and Responsibilities:As part of Global Project & Portfolio Management (GPPM), the primary purpose of the CMC OPCM is to customize, plan and track the Research & Development (R&D) and Industrial Affairs (IA) CMC activities with their timelines, resources and costs reflecting the operational reality and aligned with the overall global project strategy.Evolving in a global and international environment, the CMC OPCM is a member of the CMC Project Team covering scope from Research, to Preclinical and Clinical Development, and then Product launch on the market.For each assigned bio-therapeutic project (monoclonal antibody, gene therapy, enzyme replacement therapy) and once agreed with the CMC Project Team actors, the CMC OPCM is the single accountable person for the accuracy of the plan entered and regularly updated in the planning tool. The CMC OPCM ensures that the CMC strategy is accurately reflected in terms of project logic with the timelines, resources and costs.In addition, the CMC OPCM provides workload and capacity analyses, and reporting to support the CMC Project Team and Managers in the CMC Functions. In particular, he/she develops scenarios to make recommendation on optimization of timelines, costs, resources, and to support decision for site re-allocation or outsourcing if any bottleneck.The CMC OPCM also analyzes the project deliverable timelines and critical path activities e.g., in support to CMC risk management assessment by the CMC Project Team.The position is located in FraminghamKey interfaces:CMC Project Team members covering the whole CMC development in R&D and IA including Clinical and Commercial Supplies, Regulatory and Quality.Global Project Planning Managers embracing the project strategic planning.OPCMs working on other operational activities like preclinical and clinical development.CMC Functions Managers on local sites and also Finance, Controlling, Contract Management, etcThe whole community of CMC OPCMs working on all types of molecule modalities located in Frankfurt, Paris, Montpellier and Boston area USAEducation & Experience:Pharmacist / Engineer / MS / MBATraining and experience in Project Planning and ManagementSkillsAnalytical, synthesis and reporting skillsExcellent organizational skills, rigor, striving for results, high accuracy orientatedGood knowledge in planning and management toolsGeneral knowledge on Project Management with ideally a first experienceGeneral knowledge on overall Pharmaceutical R&D Drug Development and good knowledge in CMC operational activitiesStrong communication skills and interpersonal relationship demonstratedKnowledge in Finance and budgetExcellent presentation skills (verbal and written)At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will 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.GD-SGLI-GZPDNAt 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.PDN-9507110d-5b18-4822-87e3-173d62456f25

Keywords: Sanofi, Framingham , CMC Operational Planning & Capacity Manager, Executive , Framingham, Massachusetts

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