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"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
Sanofi is looking for a leader in the field of cell culture development to join the Cell Culture Development Group located in the Framingham, MA in the role of Associate Director. The Global Cell Culture Development group within Sanofi operates with the mission to develop robust, scalable and innovative cell culture processes for Sanofi’s very diverse early and late-stage biologics pipeline.
We are looking for a candidate with excellent scientific, communication, project management skills to lead both a team of upstream development scientists and engineers, and to lead cross-functional projects spanning multiple departments. In addition, as a senior staff member of the Cell Culture Development Framingham organization, he/she is expected to work collaboratively to establish objectives, priorities and directions for the department, and to represent the function in stakeholder meetings.
Job Duties and Responsibilities
Lead cross-functional drug substance development teams
Build aligned drug substance project plans across drug substance functions including Cell Line and Banking Development, Upstream Development, Purification Development, BioProcess Engineering, and Drug Substance Manufacturing Biologics.
Represent the drug substance function on project CMC teams and ensure alignment of drug substance team strategy with other CMC team representatives
Monitor progress according to plan and inform functional management of issues and escalate challenges as appropriate
Lead a group of scientists and engineers focused on upstream process and technology development
Independently plan and lead the execution of upstream process development for assets in all stages of the development lifecycle.
Plan department resources for supported projects to ensure timely delivery of department objectives
Align department development activities against overall project goals.
Ensure that the functional project team maintains high quality deliverables, open communication, and a good working environment.
Oversee the professional development of scientists in the team. Ensures that group maintains proper and updated training.
Serve as a subject matter expert in one or more selected areas of cell culture development and support the entire upstream development portfolio
Provide technical expertise to assist in resolution of complex problems
Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences.
Participate in the design and implementation of concepts for i.e., control strategy, validation strategy, developability, manufacturability, processing, disposable technology, and digitalization
Lead projects to develop and implement industry leading cell culture production technologies and platforms
Build strong interfaces with global Cell Culture Development community and help drive global adoption of best practices
PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering or related field with at least 7 years of relevant industrial experience, MS with at least 11 years of relevant industrial experience, or BS with at least 12 years of relevant industrial experience.
Experience in the biotech/pharmaceutical industry within a mammalian cell culture role and an excellent understanding of the theory and practice of cell culture process development.
Experience developing processes for single use and stainless steel bioreactors and working knowledge of cGMP requirements.
Experience authoring regulatory documents and responding to agency information requests.
Demonstrated understanding of bioreactor scale-up and mass transfer principles.
Excellent oral and written communication skills to build relationships both inside and outside the cell culture development function.
Experience directly managing 3 or more junior staff.
Experience in managing cross-functional project teams and initiatives.
Experience with cell culture medium and feed development.
Track record of scientific publications and conference presentations.
Experience with use of PAT and building models using spectral data.
Experience with cell line engineering to address process development challenges.
Experience using “omics” tools for optimization of cell culture processes.
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.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
At 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.