Sanofi Group Principal Scientist in Cambridge, Massachusetts
SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES
In compliance with Sanofi Pasteur’s policies (quality, HSES), the Sr Principal Scientist oversees the mRNA vaccine process development strategy and drives the proprietary mRNA vaccine platform. This highly skilled and motivated Sr Principal Scientist will support the process development of first-in-class messenger RNA (mRNA) based medicines and lead the global mRNA implementation at the Drug Substance and Drug product stages in Bioprocess R&D to enable our clinical supply. The applicant should have strong communication and collaboration skills, along with examples of a strong technical background. He/She works in close collaboration with REI, MTech and Analytical Science and develops the internal and external networks required to support successful CMC implementation of this new technology.
To lead the Drug Substance mRNA strategy process development.
To support and coordinate the process development, specifically in the field of expertise pertaining to in Vitro transcription in enzyme kinetic.
To lead the mRNA platform data-management, automation, Modelling.
A subject matter expert within Sanofi Pasteur, contributing to cross-functional experimental programs, making internal and external presentations, contributing to regulatory submission documents, patent filings, and preparing scientific publications.
To lead relevant transversal working groups (e.g. VITA) on the mRNA technology
To propose a new mRNA process with new industrial manufacturing steps, with a specific example to replace the ethanol precipitation step by another technology.
This position may also act as a CMC DS Subteam Leader for Sanofi Pasteur/ Sanofi projects
Ensure compliance with employment and health and safety legislation, and ensure to work within the policies, procedures and regulations applicable to their work
Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner
Takes every reasonable precaution to ensure the health and safety of self and staff
Ensures that protective equipment and clothing required is used
Cooperates and assists the Joint Health and Safety Committee in carrying out its functions
Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act
CONTEXT OF THE JOB/MAJOR CHALLENGES
Identification, evaluation and implementation of progressive technical CMC solutions by leveraging VITA, SME, GBIEs, and best industry standards
Ensure technical, scientific and strategic issues are resolved in order to achieve project milestones, on-time, on-budget.
Coordination of CMC activities involving complex partnerships of internal and external stakeholders in order to ensure NV projects are advanced through the completion of clinical trials.
Ensuring CMC risk management and contingency plans are in place in order to advance NV projects
- PhD in Chemical Engineering, Chemistry, Biochemical Engineering, Biochemistry or closely related field with 5-10 years of relevant experience post-PhD and 10 years relevant industry experience. Preferred: Experience/education in pharmaceutical sciences and/or biotechnology process/product development.
15+ years’ experience in the process development for the preparation of biological material for clinical applications, such as diagnostics, therapeutics or vaccines
15+ years in a scientific leadership positions such as scientific team
Preferred: Familiarity with nucleic acid and protein chemistry, enzyme kinetics, and analytical characterization of biomolecules
Preferred: Hands-on experience with Hight throughput equipment, automation, digitalization and data management approaches.
In-depth knowledge of the principle discipline and cross-training in Immunology, Cell biology, Molecular Biology, Molecular Genetics, Genomics and Bioinformatics, Chemical Engineering, Cell and Viral Culture, Formulation and Stability, Genomics and Bioinformatics.
Track record of working with collaborators and outsourcing partners including large biotech, small biotech, CROs, CMOs, research institutes, and universities.
Due diligence experience for CMC elements for biologics, vaccines, and technology.
In depth knowledge of experimental work and data analysis. Working knowledge of computer skills, scientific writing and presentations, supervisory/management/people development, communication skills, innovative thinking, and a familiarity with strategic planning, balanced judgment, risk analysis and budget process is required.
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.