Framingham, MA, 01701, USA
2 days ago
Head of Scientific Excellence
**Job Title** : Head of Scientific Excellence **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. **Sanofi’s Global MSAT (Manufacturing Sciences, Analytics, and Technology)** acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization. Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products by year. The **Head of Scientific Excellence** provides scientific expertise to accelerate technical modernization for product commercialization within the MSAT Recombinant Drug Substance (DS) platform. Core platform activities include product transfers, process monitoring, validation, material management, facility design and CMC requirements. The role will provide scientific expertise supporting CMC regulatory guidance with innovative approaches to process and analytical comparability, whilst supporting product technical teams to assess risk, probability of success and change management strategies. The role will support the platform implementation and excellence for modernization initiatives. In addition, the role will have responsibility for material sciences to drive improvements in material quality and leverage supplier partnerships for MSAT activities with consideration of eco-design. 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:** + Provide Scientific Expertise to advance CMC comparability strategy and approaches to enable health authority acceptance with evolving regulatory practices and guidance. + Provide structured approach for modernization initiatives to drive platform excellence for key activities supporting new product introduction and 2nd generation products. + Material Sciences leadership to drive improvements in material quality and testing standardization (L&E). Leverage supplier partnerships for accelerating technical innovation and efficiency gains for technical project provision. + Provide oversight on strategies and approaches for cell bank management including testing, qualification and supply security. + At Sanofi, we have charted a clear path forward to not only minimize the environmental impact across our value chain but also adapt our business to the environmental challenges that we face, promoting Environmental Sustainability by Design through our eco-design approach. This role will drive and execute the strategic direction of Environmental Sustainability by Design initiatives with the organization, fostering a culture of environmental sustainability and innovation in pharmaceutical development. **About You** Education: + PhD/Master’s degree in Life Sciences and/or Chemical Engineering, Biotechnology, Biology, Biochemistry, Pharmacy, or related. Experience: + 10+ years of broad and long-term experience in the biotech/ pharmaceutical industry, specifically in R&D and/or MSAT (industrial development) with manufacturing cGMP considerations, and global CMC projects. + 5+ years of experience with CMC regulatory guidance specific to process/analytical comparability and health authority submissions. + 5+ years of leadership experience - Proven capabilities to lead a cross-functional team in a matrix organization. Global exposure and stakeholder management experience. + Experience with material management including evaluation, change control and testing. + Specialist knowledge in one or more areas; material sciences, Single-Use technologies (SUT), technical process or analytical platform evaluation. + Preferred experience with cell bank qualification and management. + Strong scientific background in biological process development (mammalian and/or microbial) and/or product analytics. + Good understanding of cGMP requirements and facility operations. + High experience in exposure to change management and transversal collaboration **Soft skills** + Proven capabilities to lead a cross-functional team in a matrix organization. Global exposure and stakeholder management experience. + Able to lead and animate networks, teams, experts - Excellent communication and interpersonal skills, stakeholder management skills. + Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focused on priorities. + Results orientation: Demonstrated ability to drive initiatives from concept to execution. + High level of autonomy. Comfortable with ambiguity and adapts with high agility. + People development: Engages and leverages everyone’s strengths while being highly self-aware. Ability to set ambitious goals, communicate & align priorities across the organization. + Relationship & Influence: able to manage ambiguity and partners without solid reporting line. Ability to influence outside M&S (CMC Dev, Finance and global regulatory) + Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks. + Commit to patients and full product quality. Makes sure the teams understand how to act for patients and customers. + Issue resolution and decision-making skills. **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-SG \#LI-GZ \#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: $202,500.00 - $292,500.00 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)
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