**Job Title:** CMC Project Lead **Location** : Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Global CMC Project Management is a CMC project centric organization leading new product development to deliver innovative medicine for our patients with agility & strategic excellence. Our mission is to lead projects of the Sanofi R&D pharma portfolio from pre-candidate selection to approval. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? **Main Responsibilities:** + The early-stage CMC Project Leader (CMC PL) is accountable for the CMC project activities of mammalian projects of Sanofi’s R&D Pharma pipeline for pre-clinical and early clinical development from pre-candidate selection (PCS) to proof of concept (POC). + For this mandate, he/she leads a cross-functional CMC team with functional members/sub-team leaders from R&D CMC including mammalian DS platform, drug product & formulation platform, Bioanalytics, device development, quality, regulatory CMC, CMC dossiers, and clinical supply chain as well as M&S representatives in accordance to development phases. He/she has an oversight in CMC and sub-teams of approximately 30-50 FTEs. + The CMC leader with his/her team in alignment with the CMC functions, creates a strategic and integrated CMC development plan based on global project objectives ensuring alignment with base case and accelerated plans and exploring opportunities for acceleration. + He/she represents the CMC team and functions as core member in the Global Project Team, contributes to overall project strategy and executes the appropriate actions within CMC to achieve project goals. Following the TPP, he/she defines the Quality Target Product Profile (QTPP) + He/she acts as overall product/process expert for the project and provides technical and scientific expertise on major project topics, drives and leads technical and scientific discussion and alignment within the CMC team and in R&D/M&S cross-functional governance meetings (Technical Review meetings, CMC Boards, RWG, DWG…). + He/she is responsible for quality of CMC contributions to pre-clinical and early clinical phase activities, and CMC elements for regulatory submissions and consultations. He/she assesses together with functions developability/manufacturability. + With the CMC team, he/she drives the evaluation of CMC risks and appropriately escalate to Senior Management (Cluster Head, Platform Head & Global Management as needed) and Global Project Team and proactively provides mitigation plans. He/she alerts decision makers and stakeholders to risks that can impact critical program timelines. In case of scientific/technical issues, he/she coordinates corrective measures across functions in cooperation with all relevant site and department heads. + He/she is responsible for implementation of CMC deliverables within budget considering external and internal costs. He/she leads and oversees planning of CMC project budget including communication and alignment with global project team and senior management. **About You** **Education & Experience:** + PhD, MS, other university degrees in one of the areas of biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry). + 10 years professional experience, ideally in CMC development, is required. **Soft skills:** + Leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders + ideally experience in leading international and/or multi-cultural teams + Good communication skills + Ability to work in a matrix organization + Experience in stakeholder management, ability to interact effectively with management and external bodies (e.g., auditors, health authorities, etc.), networking skills + Influencing and negotiation skills to build solutions and partnership + Objectives and deliverables / results oriented. Capable to deliver under high pressure + Take responsibility for decisions and accountable for results + Ability to challenge status quo and to propose alternatives **Technical skills:** + Strong expertise in Biologics CMC area, with proven experience in at least 2 scientific areas, e.g., analytics, process development, regulatory CMC, manufacturing, etc. + Comprehensive scientific background in biotechnology and/or protein science + Experience and understanding of current pharmaceutical environment including the economic and regulatory challenges. + Experience in working in cross-functional project team and in complex environment (e.g., activities across different sites) **Languages:** + Fluent in English **Why 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. 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-SA ​ \#LI-SA \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better 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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi 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 Only_ The salary range for this position is: $172,500.00 - $249,166.66 All 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 (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)