Senior Scientist, Upstream MSAT

DEPARTMENT DESCRIPTION :

The Senior Scientist position is part of the Upstream team in the Recombinant Drug Substance function within global Manufacturing Sciences, Analytics, & Technology (MSAT) and is based at the Mammalian Platform hub in Framingham, MA. The MSAT mission is to enable the reliable supply of medicines by providing expert technical and scientific support for their licensure, ongoing commercial manufacturing, and life-cycle management activities.

Join our global network that contributes to the launch of 3 to 5 new products annually across various modalities and an expansive portfolio, enabling us to reach and serve more patients and communities. Collaborate with a team of talented and passionate international experts, scientists, and project leaders who are dedicated to inventing, designing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modelling, all in support of Sanofi’s best-in-class ambition.

The Recombinant Drug Substance function within global MSAT is the owner of Life Cycle Management (LCM) of DS processes. Implementation of second-generation processes is one of the top performance enablers for Sanofi’s biologics manufacturing network and integral to LCM. We deliver innovative, robust, and cost-effective next generation processes. In recent years we have successfully established second-generation manufacturing mammalian processes with a continuous process platform and developed a robust fed-batch platform for large scale manufacturing. The function is responsible for tech transfer, process validation, dossier preparation, & PAI support to enable launch of new and LCM products. 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 process-related manufacturing investigations and process improvements for commercial products. We are looking for a candidate with excellent scientific, communication, and project management 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 include:

• Lead Upstream project teams encompassing study design, execution, and data analysis, with the aim of improving process robustness and developing next-generation processes for monoclonal antibodies and recombinant proteins

• Prepare presentations and data sets to effectively communicate results, progress, and plans within the department and as the Upstream representative on technical product, CMC, and technology transfer teams.

• Contribute to or lead technical investigations of complex deviations in manufacturing

• Work collaboratively with technical leads and SMEs in R&D and in MSAT downstream, analytical, and pilot plant teams

• Serve as a technical leader in introducing and developing new technologies, platforms, and capabilities in the Upstream laboratory

• Lead or participate in the set-up and maintenance of Upstream laboratory systems, practices, and training

• Responsible for internal documentation and preparation of reports required for regulatory filings. May support authoring of regulatory filings.

• Mentor Upstream project team members in a matrix managed setting. May supervise a small team of scientists and engineers.

• Represent the Upstream team as an SME or technical lead in cross-site, cross-functional teams with external partners and CMOs

BASIC QUALIFICATIONS:

• Degree in life sciences, engineering, or other relevant degree

• Minimum years of experience: BS with 9 years, or MS with 7 years, or PhD with 5 years

• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations

PREFERRED QUALIFICATIONS:

• Excellent scientific background, technical writing, and presentation skills

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

• Hands-on experience with mammalian cell culture process development at laboratory, pilot, or manufacturing scale

• Knowledge in bioreactor design and control strategies, scale up and scale down approaches as applied to mammalian-expressed proteins

• Self-motivated with excellent attention to detail and superb organizational skills, having a proven ability to work in a highly collaborative environment and communicate transversally.

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

• Experience managing and developing scientific staff

• Demonstrated ability to become a cell culture SME in a relevant field, e.g. medium development, omics, PAT, cell banking, process intensification, scale up / down, or process automation or miniaturization

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