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Director of Downstream, Global MSAT

Company: sanofi
Location: Framingham
Posted on: September 13, 2022

Job Description:

TeamThe drug substance function within global Manufacturing Science & Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within the Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next-generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, preparing dossier sections, & PAI support to enable the launch of new and LCM products. Our expansive portfolio covers 19 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting the launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins, and nanobodies. In recent years we have successfully established a second-generation manufacturing process with a continuous process platform. We are pursuing future innovations such as digital labs, factories of the future, and advanced analytics-based process understanding and control.Job HighlightsThis role will lead downstream team at Framingham as a part of the global downstream team within global MSAT, Specialty Care Operation. Key responsibilities include:*Manage a group of scientists and engineers to support internal and external manufacturing. Routine activities include process monitoring and continuous verification, deviation and change control management, yield and process robustness improvement, annual report and inspection support, and lab experiments using a scaled-down model. Play a key leadership role in global network.*Lead Tech transfer, scale-up, and facility fit, control strategy implementation, process validation, process comparability for internal/external new program launch, and manufacturing network expansion.*Lead Sanofi 2nd Gen process development and regulatory filing, digital transformation, continuous E&E downstream process, and platform innovation. The multi-year project scope covers early-stage and late-stage process development, process validation, comparability demonstration, BLA filing, and commercial launch. -*Work with upstream, analytical, and other MSAT functions to support all aspects of LCM activities.*Work with quality, operation, regulatory, raw material, procurement, and other Sanofi teams to drive cross-function initiatives such as global guidelines for process validation strategy.*Work with internal research and CMC team to guide late-stage development and control strategy implementation (including scale-up, process validation, and commercial launch).*Work with external partners and alliance to support additional manufacturing capacity and 2nd Gen process development. Manage both technical and business aspect to accomplish MSAT priorities.*Work with HR and senior leadership to implement talent development principles and build a high-performance team. Advocate MSAT reputation in scientific excellence and technical leadership both internally and externally. -Sustain a"Play to Win" culture in evolving team environment.Basic Qualifications*Degree in life sciences, engineering, or other relevant discipline -*MS with 10-15+ years of professional experienceOR*Ph.D. with 8-10+ years of professional experienceAND*Minimum of 5 years of Supervising a technical team in process development or manufacturing supportPreferred Qualifications* Manufacturing support and/or Process development experience*In-depth understanding of biological purification and separation fundamentals*Process Knowledge across modalities (mAbs, bioconjugates, nucleotides, Gene/cell therapy, organic chemistry, etc.)*Prior experience with managing Ph.D. level scientists*Excellent scientific background and communication skillsSPECIAL WORKING CONDITIONS: *Up to 10% Domestic and International travel* Hybrid work scheduleAs 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.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.Fully vaccinated, 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. - 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-GZAt 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.

Keywords: sanofi, Framingham , Director of Downstream, Global MSAT, Executive , Framingham, Massachusetts

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