CMC Operational Planning & Capacity Manager
$122.25k - $176.58kSanofi
Job Title: CMC Operational Planning & Capacity ManagerLocation: Framingham, MAAbout the Job:As part of the CMC Operational Planning & Capacity team, the primary role of the CMC OPCM is to customize, plan and track the CMC activities in Research & Development (R&D) and in Manufacture & Supply (M&S) with their timelines and resources reflecting the operational reality and aligned with the overall global project strategy. R&D scope is from Research to Preclinical and Clinical Development, and Product Life Cycle Management post initial market approval.Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.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.Main Responsibilities:For each assigned therapeutic project (biologic molecule) and once agreed with the CMC Project Team actors, the CMC OPCM is the single accountable person for the accuracy of the entered plan and regularly updated in the planning tool (Planisware solution). The CMC OPCM ensures that the CMC strategy is accurately reflected in terms of project logic with the timelines, including the CMC High Level Plan, and resource workload,In addition, the CMC OPCM provides workload and capacity analyses and reporting to support the CMC Project Team, and Managers in the CMC Functions if assigned as Function Business Partner. In particular, he/she develops scenarios to make recommendations on optimization of timelines and of resources, and to support decisions for site re-allocation or outsourcing if there is any bottleneck,The CMC OPCM also analyses the project deliverable timelines and critical path activities e.g., in support of CMC risk management assessment by the CMC Project Team,The CMC OPCM is also responsible for ensuring alignment of his/her CMC activities with global strategic project planning and other operational planning from Translational Medicine, Clinical Sciences and Regulatory Affairs, while ensuring proper connectivity and integration of these cross-functional dependencies within the planning tool.Evolving in an international environment, the CMC OPCM regularly attends CMC Project Team meetings, planning meetings and other related meetings linked to project timelines and resources management (e.g., R&D governance preparation, CMC Function review) and to OPCM business management.Key Internal Relationships:CMC Project Team members covering the whole CMC development in R&D and M&S 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, clinical development and regulatory,CMC Functions Managers on local sites and Finance Business Partners,The whole community of CMC OPCMs working on all types of molecule modalities located in Frankfurt & Berlin-Germany, Paris & Montpellier-France, Boston area-USA and Budapest-Hungary.About You:Basic QualificationsEducationBachelor's degree, Master's degree, PhD, or MBA in a scientific, technical, or business-related field (e.g., Pharmacy, Engineering — including Chemical, Electrical, or Mechanical —, Biology, Chemistry, Business Administration, or equivalent).Experience5+ years (Bachelor's), 3+ years (Master's or MBA) OR 2+ years (PhD) of experience in project planning and management and/or CMC operational/laboratory activities within the pharmaceutical, biotechnology, or related regulated industryRelevant academic/research experience (e.g., co-op, internship, or postdoctoral research in biology or pharmacy-related fields) may count toward the total years of experience when combined with industry experience.Preferred QualificationsProactive adoption of Digital and/or AI solutions in a work environmentExperience in Biologics and/or Gene Medicine CMC operationsFamiliarity with AAV (adeno-associated virus) or LNP (lipid nanoparticle) platformsKnowledge of planning and project management tools (e.g., Planisware or equivalent)PMP or CAPM certificationExperience with data visualization tools such as Tableau or Power BI, or advanced Excel skillsKnowledge of finance and budget managementWhy 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.Help improve the lives of millions of people globally by making drug development quicker and more effective.Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.Achieve genuine work-life balance in a supportive R&D environment.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-SG#LI-GZ#LI-Onsite#vhdPursue 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!US and Puerto Rico Residents OnlySanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.North America Applicants OnlyThe salary range for this position is:$122.250,00 - $176.583,33All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.SummaryLocation: Framingham, MAType: Full time
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