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"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."Shannon Resetich US Head Rare Diseases & Blood Disorders
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Position: Scientist II, Upstream, Manufacturing Science and Technology
The Scientist II position is part of the Upstream team in 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 (DS) function within global MSAT is the owner of Life Cycle Management (LCM) of DS Processes within 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, prepare dossier sections, & 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 US and EU. We will be supporting launch of 20 new products in 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 process with continuous process platform. We are pursuing future innovations such as digital labs, factory of 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 Position Responsibilities:
Design and conduct experiments; interpret results; build process understanding and recommend improvements implementable in manufacturing
Analyze process development and commercial manufacturing data in support of the MSAT mission; present data and results to department and project teams
Mentor Upstream project team members in a matrix managed setting and provide technical training to lab staff
Contribute to/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/lead technical investigations of complex deviations in manufacturing
Contribute to/lead establishment of best practices and technical ways of working within development and manufacturing teams
Collaborate with other scientists/engineers across the biologics manufacturing network within Sanofi and with partnership organizations
Represent the Upstream team as an SME or technical lead in cross-site, cross-functional teams
Responsible for internal documentation and preparation of technical reports required for regulatory documents. May support authoring of regulatory filings
Degree in life sciences or engineering discipline
Minimum years of experience: BS with 7 years, or MS with 5 years, or PhD with 2 years in Bio/Pharma industry
Experience in biologics development, bioprocess engineering, technology transfer and / or commercial manufacturing operations
Excellent scientific background, technical writing, and presentation skills
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 with statistical data analysis and software tools
Self-motivated with excellent attention to detail, having a proven ability to work in a highly collaborative environment and communicate transversally.
Experience of working in a team environment with other technical staff
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.
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 with other cell culture systems or modalities, such as insect cell culture or gene / cell therapy
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.