Sr. Associate Scientist, Upstream, Pilot Lab

DEPARTMENT DESCRIPTION :

The Senior Associate Scientist position is part of the Global MSAT Pilot Lab Cell Culture team in the drug substance function within global Manufacturing Science, Analytics and Technology (MSAT) and is based at the biologics hub in Framingham, MA. MSAT's mission is to enable the reliable supply of Specialty Care (SC) medicines by providing expert technical and scientific support to their licensure, ongoing commercial manufacturing, and life-cycle management activities.

The drug substance (DS) function within global 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 scale-up, process fit-gap assessment, process validation, preparation dossier sections, & PAI support to enable the launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, and 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.

POSITION OVERVIEW /KEY RESPONSIBILITIES:

The Senior Associate Scientist will be a key contributor to the Pilot Plant Cell Culture group. The successful candidate will apply scientific principles and utilize/Operate Disposable bioreactor systems ranging from 2L to 500L scale, various filtration techniques, and separation technologies to improve current commercial and develop next-generation processes of monoclonal antibodies and recombinant proteins, with responsibilities spanning bench and pilot-scale process development & characterization, as well as the support of technology transfer to manufacturing facilities. This individual will work in a team environment, collaborating with various colleagues in the organization to solve a wide range of complex problems in creative and practical ways.

Specific Responsibilities include:

  • Work collaboratively within the Pilot Plant Cell Culture group to execute and participate in the design and execution of experiments

  • Execute experiments, perform data analysis, and interpret results independently

  • Present data and results within department and project teams

  • Author internal procedures and technical reports

  • Contribute to project teams for technology transfer to pilot scale or commercial manufacturing

  • Collaborate with cross-functional and cross-site teams

  • Set up and maintain upstream laboratory equipment, systems, and training

BASIC QUALIFICATIONS:

  • A Bachelor’s degree in Chemical / Biochemical engineering, biology, biochemistry, or related background with 2+ years relevant industry experience.

  • Must have permanent US work authorization.

PREFERRED QUALIFICATIONS:

  • Experience in the Biotechnology or Pharmaceutical industry in a development or GMP facility

  • Hands-on experience at laboratory, pilot, or manufacturing scale for biologics products

  • Knowledge in Cell Culture process development, experiment design, and control strategies, scale up and scale down as applied to mammalian-expressed proteins

  • Excellent Manufacturing background a strong plus

  • Highly motivated individual with the ability to work independently and on cross-functional and cross-site teams

  • Strong technical writing and presentation skills

  • Experience with statistical analysis software

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.

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.