Principal Scientist

Job Title: Principal Scientist

Location: Framingham, MA

About The Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofis Global MSAT (Manufacturing Sciences, Analytics, and Technology)acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization.

Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products by year.

The Principal Scientist in Downstream Process (DSP) will be part of the subject matter expert team and is responsible for providing technical leadership in monitoring and improving chromatography and filtration process performance at pilot and manufacturing scale. As a member of the Center of Excellence team, this role will work crossfunctionally to deliver critical contributions to Sanofis smart laboratory and smart manufacturing transformation, connecting scientific, operational, and digital stakeholders to accelerate implementation and value creation.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Lead downstream bioprocess innovations from conceptualization to implementation. Work with MSAT teams and other functions (R&D, manufacturing, Tech Transfer) to design and implement current innovations in platform technologies such as custom designed chromatography or filtration skid, continuous DSP configuration and PAT, custom fabricated resins, filters, absorbers, and fibers. Lead collaboration with Sanofi suppliers and external partners to enable preferred or alternative raw material supply with acceptable standards. Champion nextgeneration digital and automation solutions for MSAT labs and the pilot plant, advancing the Center of Excellences mission to build a fully connected smart laboratory and smart manufacturing ecosystem
• Represent MSAT as a DSP subject matter expert (chromatography and filtration) in various technical forums within the broad Sanofi network. Drive DSP operation standardization and best practice across platforms (Mammalian, Microbial, Vaccine). Serve as a core point of contact to support MSAT programs and global manufacturing sites, and to collaborate with R&D/CMC teams.
• Lead complex manufacturing investigation such as large column packing performance; pre-packed column quality, raw material (resin and filter) quality and performance, chromatography and filtration skid equipment cleaning/sanitization/storage, filter integrity test variation, bioburden and contamination control, Unit operation automation, and other scalability and manufacturability issues. Provide key technical guidance to manufacturing support teams by integrating knowledge from process, operation, equipment, and raw material.
• Work with MSAT pilot teams to establish the scale-up guidelines for various DSP operation. Draft training protocols for manufacturing staff at pilot facility. Work with MSAT and CMC pilot teams to drive the necessary pilot data package to evaluate facility fit and manufacturability. Design pilot scale studies to drive investigation and process definition.
• Support other downstream unit operations such as centrifugation, viral inactivation, freezing/thawing, and protein stability. Support next generation process development, control strategy implementation, process validation, Tech Transfer, process comparability for global MSAT program launch at both Internal and external manufacturing sites
• Support Quality and Regulatory during health authority inspection and prepare for supportive documents for new filings or responses. Lead internal report preparation to support various regulatory activities.
• Serve as a technical mentor to MSAT team members, provide training and supervision to project team members as needed. Participate in internal and external scientific exchanges to enhance MSAT competencies and reputation.
  
  
  

About You

Qualifications/ Education & work experience-need more changes here

• Masters degree in Biological/Biomedical, Sciences/Engineering or relevant field AND 10 years of biopharma industry and/or academia experience OR PhD degree in Biological/Biomedical, Sciences/Engineering or relevant field AND 5 years of biopharma industry and/or relevant academia experience
• Minimum of 5 years of hands-on experience in downstream manufacturing support or field technical support from a major supplier is preferred
• Process knowledge across multiple modalities (e.g. mAbs, small protein and peptide, bioconjugates, nucleotides, Gene/cell therapy, organic chemistry etc.)
• Extensive knowledge with pilot and manufacturing scale chromatography and filtration equipment and operation
• In-depth understanding of various chromatographic separation mechanisms including affinity, ion-exchange, Hydrophobic, and Mix-mode. In-depth understanding of different filtration fundamentals (TFF, sterile filtration, membrane and fiber applications) and different operation modes (single-pass, alternative pass, continuous, nominal and tangential)
• Prior experience of managing contractor manufacturing or contract research partners
• Excellent scientific background and effective communication skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
• Highly motivated individual with the ability to work independently as well as within cross-functional and cross-site teams
• Oral and written fluency in English
  
  
  

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.