Head of Bioanalytics GMU
沃尔瑟姆, 麻薩諸塞州 Permanent Posted on Dec. 23, 2024 Closing on Mar. 24, 2025Job title: Head of Bioanalytics GMU
Grade: L5-1
Hiring Manager: Laurent Duhau
Location: Waltham, 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.
Within Sanofi R&D, Global CMC Development is a key enabler of Sanofi’s growth aspiration through its mission to develop manufacturing processes, formulations, and analytical methods for new clinical drugs.
Global BioAnalytics provide strong, science-based and quality-driven analytical value for all biologics modalities by ensuring comprehensive understanding of our products and processes using state of the art technologies.
We are seeking a highly motivated and skilled CMC BioAnalytics Gene Therapy site head.
In this position, you will lead a group of approximately 60 scientists and will ensure the analytical development of new Gene (Viral/Non-Viral) biologics therapies from transition to research up to commercialization and transfer to Manufacturing & Supply. You will contribute strategically and operationally to the development projects of new biologic entities as functional head, providing strategic inputs and resources as well as securing the project deliverables.
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:
Ensure appropriate analytical control strategy for new gene therapy modalities
Ensure analytical development & quality control activities to guarantee quality of products used in clinical trials
Ensure state of the art molecule characterization & understanding
Ensure operational excellence of teams.
Ensure high scientific level for all analytical sections of CMC dossiers
Transfer high performance Analytical Methods to M&S
Attract, hire, maintain, and motivate high quality working force
About You:
Experience:
Broad and long-term experience in the analytical development of Biologics with expertise in Gene therapy and strong knowledge of late phase development.
Soft and technical skills:
Able to lead & animate highly scientific teams, experts - Excellent communication and interpersonal skills, stakeholder management skills
Ability to manage a large organization with strong operational excellence
High level of autonomy. Executes, comfortable with ambiguity, and adapts with agility.
Demonstrated technical, project management and organizational skills; ability to work in a matrix organization
Issue resolution and decision-making skills
Structured, goal-oriented and highly motivated
Ability to deliver results under high pressure
Strong and proven ability to work transversally on a local and global level
Strong scientific track record in analytical development of gene therapy products
Solid understanding of CMC aspects of biological drug development and related functions, including process development and formulation development
In depth understanding of Quality by Design principles & ICH guidelines
Experience of global submissions (NDA, MAA) and approval and interactions with regulatory agencies.
Experience with GMP audits.
Experience acting as an analytical team leader for a development project
Advanced scientific network within Academia and Industry
Track record of publications and patents
Education:
PhD in Analytical Chemistry or molecular biology or equivalent.
At least 15 year-experience in a similar position (Pharma Industry) including at least 3 years on gene therapy (viral & non-viral)
Languages:
English fluent.
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.
追寻 发展。探索 菲凡。
进步需要我们每个人的参与——不论其背景、地域、或职业,我们都有一个共同的愿望:创造奇迹。你也可以成为其中的一员。我们不断追求变革,拥抱新思想,探索我们所能提供的一切机会。让我们一起追求进步。共同发现非凡。
在赛诺菲,不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同,我们为所有人提供平等的机会。
观看 “在赛诺菲的一天” ,并在官网 (sanofi.com) 上查看赛诺菲的多元化、公平与包容倡议!
在美国的职位
加入我们的美国团队。我们将为您提供专家指导和培训平台,从而帮助我们营造良好的企业文化。我们鼓励您以饱满的热情和充沛的精力投入到工作中,然后发挥自身能力推进药物和疫苗的研发,同时将研发到临床治疗的时间减半。
体验可能性
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Ama
Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.
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Cambridge Crossing
We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.
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Innovation in Action
Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.
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Sanofi’s AI Centre of Excellence in Toronto
The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.
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Sanofi Canada's Philanthropic Efforts
By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.
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Sustainable and Green
Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.
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我们的办公地点
我们的员工遍布60多个国家/地区。他们勠力同心,携手共创医疗健康领域的美好未来。无论您在哪里工作,我们的专家都会指导您推动职业发展,您也将能够运用先进的科学技术,取得意义非凡的重大突破。
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勇敢追梦,奔赴美好未来
想要改变自己的生活,乃至改变全球数百万人的生活,该怎么做?加入我们,开启职业新篇章,然后在我们的保驾护航中展翅高飞,并向优秀的人求教,为这份事业做出切实的贡献。
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您和我们相互依存,共同成长
我们精心打造薪酬体系,为您的身心健康、财务健康与社交健康提供全面保障。我们有着海纳百川的包容性团队文化,无论您在哪个岗位,都能展翅高飞。
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心怀梦想,成就一番事业
我们希望您以饱满的热情投入到自己的工作岗位中,给全球数百万人带来美好生活。您的职业发展道路由您自己来掌控。您只管制定目标,我们会提供充足的培训机会和支持,让您得偿所愿。
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我们的人与文化
我们是首个建立多元化、公平性和包容性(DE&I)委员会的制药企业。我们还建立了“菲常联盟”,为每位员工提供发声的平台。您的声音是我们建设未来道路的重要基石。
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我们的故事
我们关注每一个员工的声音。因为,我们的未来取决于所有员工的付出与努力。正因为他们的助力,我们才能追求远大的理想。
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为什么选择我们?
我们为您提供各种工具、支持和培训机会,帮助您实现自己的目标。我们也希望您充分发挥潜力,帮助我们实现目标:将新药研发到临床治疗的时间减半。