Sanofi Group Senior Scientist, Upstream Manufacturing, Science & Technology in Framingham, Massachusetts
Position: Senior Scientist, Upstream MSAT
DEPARTMENT DESCRIPTION :
The Senior Scientist 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 SC (Specialty Care) medicines by providing expert technical and scientific support to their licensure, ongoing commercial manufacturing, and life-cycle management activities.
The drug substance 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, 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 proteins, antibody-drug conjugates, 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, 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 LCM product teams and technology transfer teams.
Contribute to or lead technical investigations of complex deviations in manufacturing
Work collaboratively with technical leads and SMEs in the downstream, analytical, and pilot lab areas
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
Minimum BS degree required AND 9 years' industry experience OR
MS with 7 years' industry experience OR PhD with 5 years' industry experience AND
A degree in a life science or engineering discipline AND
Experience in biologics development, bioprocess engineering, technology transfer ( for mammalian cell culture processes ) AND/OR commercial manufacturing operations
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
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.
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
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 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.
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 Group Jobs