Massachusetts Green Jobs

Job Description

Cell Culture Development within the Mammalian Platform organization is responsible for the development of cell line and cell culture technologies and processes that support all phases of CMC from pre-candidate selection through BLA. As a member of the Cell Culture Development leadership team, this leader will lead and manage a scientific team responsible for the development of the next generation molecular, cloning, and bioinformatics technology platform for cell line development. Focus will be on drastically enhancing the productivity and speed of development of cell lines used for the production of mAbs and complex biologics. Relevant technology areas include targeted integration, host engineering and evolution, advanced genome editing tools, application of NGS and biomarkers to expedite development as well as innovation in vector science. This team will own the CLD platform, be accountable for all its upgrades and technology implementations. It will also collaborate with the cell culture process groups to ensure synergy and seamless transition into the media/process platform for production. The leader will work closely with the Cell Line and Bank Development (CLBD) group as well as Research in ensuring timely and successful roll out of platform improvements for pre-candidate selection and FIH. He/she will also be responsible for the conversion of external project molecules into the Sanofi cell line platform, where applicable. The position will have wide-ranging discretion and independence in charting the future direction of Sanofi’s expression system technology for biologics.

Duties and Responsibilities

• Lead innovation in cutting-edge technology to advance the CLD platform that can achieve higher cell line productivity in record development time

• Maintain state-of-the-art platform by continually developing and implementing regulatory-friendly platform improvements

• Develop business operations process with Research, CLBD, process development groups for the efficient delivery of next generation cell lines for clinical and commercial production.

• Develop phase-appropriate CMC strategies for adopting new cell line technology that can support high supply demands while meeting comparability

• Provide scientific strategy and guidance to staffs. Manage their development and build an innovative, talented team.

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

Basic Qualifications

• Degree in life sciences, engineering, or other relevant discipline

• BS/MS with 15+ years of relevant professional experience, OR

• PhD with 10+ years of relevant professional experience

Required Skills

• Proven experience in CHO cell line development for commercial use

• Strong CMC experience covering IND and BLA filings

• Previous leadership experience in successfully managing and developing scientific staffs

• Proven skills in building and maintaining productive relationships with cross-functional partners such as in research and process development

• In-depth knowledge of state-of-the-art genome editing tools for host engineering, vector design, transfection and high-throughput cloning techniques

• Working knowledge of NGS technologies for gene expression and integration analysis

• Strong background in molecular cloning, gene regulation and CHO cell metabolism

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

• Ability to effectively translate innovation into business value that benefits the pipeline

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.

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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.