Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases.
The company's heritage, to create vaccines that protect life, dates back more than a century. Every day, the company invests more than one million Euros in research and development.
Sanofi Pasteur SA is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.
- Identify and manage the required resources for the viral manufacturing unit (personnel, equipment and raw material).
- Ensures acceptable training and development of the employees supporting the unit.
- As required, author, review and verify the regulatory documentation related tot he Manufacturing Process.
- As required, author and review SOPs, SWIs, Batch records, change controls and other documentation as required for the process.
- Defines process maps and general flow chart (different activities/steps)
- Participates in evaluation nd assessment of risk for different technical solutions.
- Participates in functional analysis/value analysis and safety reviews.
- Identifies process control requirements (process robustness in particular) and participates in the definition of instrumentation requirements and controls.
- Identifies IPTs and process characterization requirements.
- Defines control steps and testing.
- Ensures that the unit is qualified.
- Prepares scale up operations and process validation.
- Ensure acceptable preparation and execution and reporting of the process validations efforts for the manufacturing processes.
- Ensures that acceptable validation master plans are available.
- Maintains high level of professional expertise through familiarity with all equipment and processes. Contributes to manufacturing unit and assists with troubleshooting.
- Acts as liaison with representative outside of the assigned group/area as needed.M*
Sanofi Pasteur SA is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.
Requirements:
BS/MS in Chemical Engineering, Biochemistry, Biology, Industrial Microbiology or equivalent scientific discipline. 10 - 15 years technical experience in a biological cGMP manufacturing environment. Advanced degree preferred.
Works under limited supervision; work should only be required to be reviewed for accuracy and consistency with meeting overall objectives.
Extensive experience with cell culture and bioreactor processes.
Extensive experience with FDA audits and regulatory requirements for operating in a cGMP facility.
Ability to interact effectively in cross functional teams.
Excellent oral and written communication skills
Strong attention to detail is required.
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