Manager Scientist - Vaccine
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The Analytical Sciences department supports the development, qualification and validation of analytical test methods to support new vaccine candidates throughout pre-clinical and clinical phases, as well as testing support for existing vaccines throughout the manufacturing process.
Development of test methods for use as release, stability, and/or characterization assays for new or licensed vaccine products. Test method development encompasses literature search, feasibility assessment, assay optimization, and validation.
Conduct and document routine testing to support new vaccine products and manufacturing assistance investigations.
In-depth knowledge of experimental work and data analysis for analytical techniques. Subject Matter Expert in chromatographic method development and troubleshooting preferred for this position
Design and implementation of test method transfer protocols to receive and transfer assays to/from external and internal laboratories.
Author, review and approval of technical documentation, including work instructions, procedures, protocols and reports maintaining good documentation practices at all times.
Maintaining GxP compliant laboratories, instruments and testing programs where required with awareness of relevant quality, regulatory, and GxP environments.
Promote communication and good teamwork to ensure flexibility in the workplace, and to support the completion of the objectives in Analytical Sciences.
Prepare scientific publications and internal and external presentations and support regulatory submissions
Set and monitor individual objectives, conduct annual performance self-assessment and career development planning to ensure performance, competencies and skills are aligned with expectations and company goals.
Provide mentorship and training for junior staff
Test Method Development: Develop new or improved test methods for new or licensed vaccine entity characterization, stability testing and release. Understand requirements for test methods and project milestones by interacting with Project Teams, Analytical Working Groups and Platform Directors.
Test Method Validation: Validate analytical test methods in support of release and stability testing. Design and lead the validation strategy and review and approve validation protocols. Present results to Project Team, platform director or regulatory agencies upon request. Review and approve validation reports.
Test Method Transfer: Facilitate the transfer of analytical test methods in support of release and stability testing into receiving departments. Design and approve transfer protocols. Ensure the training of analysts who receive the assay. Review and approve method transfers from external and internal labs to design method transfer plans. Review and approve transfer reports.
Project support: Participate and contribute to analytical working groups as required to support project milestones and provide strategic review and direction, including detailed plans and risk assessments.
Scientific Expertise: Review scientific literature for application to vaccine development and characterization and make recommendations. Contribute to development of new platform technologies. Ability to work both independently and in a team environment as needed.
Technical Documentation: Ensure good documentation practices at all times. Maintain proficiency in quality technical documentation and current document management systems.
Health and Safety Support: Take every reasonable precaution to ensure the health and safety of staff by ensuring that protective equipment and clothing required is used by staff and advises staff of any or potential or actual health and safety hazard of which they are aware.
PhD in Biochemistry, Chemistry, Analytical Chemistry or Immunology (or related field) with 2-4 years relevant experience preferred, alternatively a MS in a similar field with 5+ years relevant experience
Specific experience in the development of new biochemical and/or immunochemical characterization methods for biomolecules/vaccines.
Familiar with a broad range of analytical instrumentation with a preference for HPLC/UPLC expertise.
Experience in maintaining laboratories and equipment in cGMP compliance.
Proven supervisory/leadership, verbal and written communication, organizational and team skills are required.
Familiarity with maintenance and use of computerized systems and data integrity requirements
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.
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.
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.