Scientist I, Upstream Drug Substance

Scientist I, Upstream Manufacturing Science & Technology

Location: Framingham, MA

Department Description:

The Scientist I position is part of the Upstream team in the drug substance function within global Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Framingham, MA. The MSAT 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 fit-gap assessment, process validation, dossier preparation, & PAI support to enable 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 the US and EU. We will be supporting 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, factory of the future and advanced analytics-based process understanding and control. 

Position Overview / Key Responsibilities:

The successful candidate will work with a group of scientists and engineers responsible for development & characterization of next generation cell culture processes, technology transfer to a diverse network of manufacturing facilities, and support of advanced manufacturing investigations and process improvements for commercial products. We are looking for a candidate with excellent scientific and communication skills. This individual will work in a fast-paced, team environment, collaborating with colleagues across functions in the organization to solve a wide range of complex problems in creative and practical ways.

Specific Responsibilities:

• Design and conduct experiments; interpret and present data/results within department and project teams with the aim of improving process robustness, building process understanding and developing next-generation processes for monoclonal antibodies and recombinant proteins

• Analyze process development and commercial manufacturing data in support of the MSAT mission

• Lead a small project team for LCM Upstream process improvements and implementation in manufacturing

• Contribute to/lead technology transfer efforts of small project team between groups/organizations

• Contribute to technical investigations of complex deviations in manufacturing

• Contribute to establishment of best practices and technical ways of working within development and manufacturing teams

• Mentor and support junior staff and build a culture of support and collaboration

• Collaborate with other scientists/engineers across the biologics manufacturing network within Sanofi and with partnership organizations

• Responsible for internal documentation and preparation of technical reports required for regulatory documents

• Support regulatory filings and interaction with authorities as subject matter experts

Basic Qualifications:

• Minimum Bachelor’s degree required and 5 years’ industry experience OR

• Master's degree with 3 years’ industry experience OR PhD with 0 year' industry experience AND

• A degree in a life science or engineering discipline AND

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

Other Skills/Competencies

• Excellent scientific background, technical writing, and presentations skills

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

• Flexible with ability to adjust to a fast-paced, goal-oriented environment and willingness to expand and broaden skillset

Preferred Qualifications/Competencies:

• Strong experience in one or more areas of upstream process development; process transfer, process scale-up/scale-down, validation, and continuous process verification as applied to mammalian-expressed proteins

• Experience with statistical analysis software

• Knowledgeable in other cell culture systems and modalities, such as microbial culture, insect

• cell culture, or gene / cell therapy

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.