Location
Waltham, MA | United States
Job description
About the Opportunity
As an experienced mRNA CMC Analytical Leader with experience in the Analytical Sciences group within mRNA CoE, you will manage CMC analytical projects for the development of new vaccines and mRNA platform. You will guarantee project execution in terms of costs, deadlines and quality, in compliance with the group/site’s HSE policies and relevant regulations.
This position is based in the Waltham, MA offices. The ideal candidate will live within a reasonable commute to Waltham, or be willing to relocate at their own expense.
About growing with us for winning with us, in this role you will
Be the “one voice” of analytical Sciences and activities in the CMC team of your project(s).
Lead the definition of analytical deliverables and tactic, and be accountable or delivering them on time
Guarantee the best navigation and handle deviation on the initial path to deliver project needs aligned with Quality standards
Ensure highly efficient project coordination & execution
Support analytical transfers with the TT team if appropriate
Provide high level of scientific expertise transversally within in the global Analytical Sciences Group
Establish and ensure a common and aligned analytical scientific vision/knowledge across mRNA CoE
Ensure projects execution, velocity and assess their impact on resources (i.e. budget impact, OPEX/CAPEX costs…).
Ensure analytical regulatory and compliance expectations for all activities
Ensures endorsement of project analytical strategy and testing profiles for your projects by relevant committees
Ensures appropriate cascading & communication to the analytical department of project decisions & information necessary to best support the projects
Ensures appropriate cascading & communication to the CMC team of analytical deliverables and activities
Liaise closely with other internal functions (Process Development, Manufacturing Technology, Clinical/Medical, Quality Assurance, Quality Control, Legal) and ensure a closely coordinated program of activities on common objectives
Contribute to product analytical characterization and control by state-of-the-art technologies internally or through innovative partnerships and collaborations
Support both the Process Development and Industrialization department and QC department in link with projects’ needs.
Contribute and review the analytical sections of regulatory documents supporting our portfolio or industrial request.
Qualifications/ Education & Work Experience
Scientific degree at MSc level or higher (PhD preferred), with minimum 8 years of pharma/biotech industry experience
Experience in analytical project management required
Good knowledge of analytics, process and mRNA/LNP products, development, validation/transfer and/or production/control techniques.
Mastery of IT tools, managing projects and deadlines, and meeting facilitation techniques, document writing and presentation of summaries
Trained in quality by design and risk analysis/management methodologies strongly preferre
Excellent verbal and written communication skills
Able to work independently and collaborate in team, enthusiastic and self-motivated
Fluent in English, French is a plus
Excellent verbal and written communication skills
Good sense for initiative and quality, accuracy and detail, team player
Demonstrate Play to Win Culture Behaviors, (Stretch, take action, act for patients and Customers, One Sanofi )
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.
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