Massachusetts Jobs

Position Summary

The global Cell Culture Development (CCD) organization within Sanofi operates with the mission to develop robust, scalable and high productivity cell culture processes for Sanofi’s very diverse early and late-stage biologics pipeline. Sanofi is looking for a leader in the field of cell culture development to join the Commercial Cell Culture Development department within CCD located in Framingham, MA in the role of Associate Director.

We are looking for a candidate with excellent scientific, CMC, communication, and management skills to manage a team of upstream scientists and lead cross-functional projects. As a senior staff member of Commercial Cell Culture Development, this leader is expected to work collaboratively to establish objectives, priorities and directions for the department, and to represent the function to stakeholders. The leader will drive the development of highly productive robust commercial fed-batch and perfusion processes leveraging strong scientific principles in medium development, cell metabolism, bioreactor engineering, and design of experiment. This will also be demonstrated by successful scale-up and transfer of the process to our commercial facilities. Commercialization responsibilities also include process characterization, validation, and IND/BLA authorship. The role will also require championing and leading cell culture innovation for the department with clear business benefits for the upstream platform and pipeline projects.

Job Duties and Responsibilities

• Develop industry-leading high performing commercial cell culture and harvest processes

• Ensure highly scalable and robust commercial processes

• Drive for product quality attribute understanding and control to meet comparability

• Deliver thorough process characterization packages using the latest advances in DOE statistical tools, multivariate analysis models and prior knowledge strategy

• Author upstream IND and BLA sections and support agency responses

• Lead cross-functional drug substance development teams

• Lead innovation projects to develop and implement industry-leading cell culture technologies and platforms

• Actively publish and present externally. Pursue IP opportunities for the company.

• Lead a group of scientists focused on upstream process development and oversee their professional development

• Serve as a subject matter expert in Cell Culture Development and support the resolution of technical challenges

• Build strong interfaces with the global Cell Culture Development community and drive global adoption of best practices

Basic Qualifications

• PhD degree in Biochemical Engineering, Chemical Engineering or Bioengineering with at least 5 to 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.

Required Skills

• Proven experience in developing cell culture and harvest processes for clinical and commercial manufacturing

• Have CMC experience covering FIH to commercial process development, process characterization, and regulatory submissions

• Working knowledge of GMP manufacturing

• In-depth knowledge of medium development, bioreactor scale-up principles, scale-down models, tech transfer concepts, and bioreactor engineering

• Working knowledge of high-throughput cell culture and automation technologies, process monitoring and control, process modeling and DOE statistics

• Strong background in CHO cell metabolism, glycosylation and product quality attribute control

• Proven track record of innovation demonstrated by a consistent record of external presentations and publications

• Ability to lead a team of scientists effectively in a matrix organization

• Excellent oral and written communication skills to build relationships both inside and outside the cell culture development function.

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.

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