COMPLETE Manager Downstream Process Development and Technologies - Framingham, MA

The Manager, Downstream Process Development in MSAT will work in a matrix team management environment with global engineers and scientists to achieve robust and scalable purification processes to support 2nd generation processes, late-stage programs, and life-cycle management. This position will support the development of purification processes for a wide variety of molecules and modalities.

In concert with Sanofi’s Patient First philosophy, this role will play a key role in developing robust and scalable protein purification processes to deliver to the manufacturing group. As part of the MSAT group, this position will also support the manufacturing team to ensure the successful technology transfers to produce pharmaceutical drugs for life-saving therapies.

The 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 17 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 second-generation manufacturing processes 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. 

RESPONSIBILITIES: 

• Manage a global group of engineers and scientists to develop robust and scalable downstream processes for monoclonal antibodies, bispecific antibodies, Fc-, Fab-, fusion proteins, enzymes, and other recombinant proteins to support GMP manufacture.

• Manage MSAT development projects, including regular team meetings and updates, data management, investigations, technical report writing, and regulatory filings.

• Manage DOE studies to establish proven and acceptable ranges (PAR) for process characterization.

• Manage technology transfer including projects for internal and external partners.

• Manage the development and implementation of new cutting-edge technologies, for DSP sciences for life cycle management projects.

EDUCATION REQUIREMENTS and EXPERIENCE

• Ph.D. in Biotechnology, or related field, with a minimum of 5+ years of relevant experience; OR

• M.S./M.A. in Biotechnology, or related field, with a minimum of 7+ years of relevant experience; OR

• B.S./B.A. in Biotechnology, or related field, with a minimum of 10+ years of relevant experience.

BASIC REQUIREMENTS

• Downstream Process development experience, Chromatography, TFF-UD/DF, micro filtration, nano filtration, and filtration

• Downstream processes at the small to an intermediate scale of cGMP biologics production.

• DOE experimental design

• Virus clearance studies

• Authoring and executing protocols, interpretation of data, and report generation.

• Technology transfer

• Supervisory experience

PREFERRED QUALIFICATIONS

• Automated chromatography platforms (e.g., GE Healthcare AKTA)

• Operating and troubleshooting process equipment.

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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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.