AD/QC Operations Manager - Vaccine
In the race for the future of healthcare – Sanofi mRNA Center of Excellence
At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. The pandemic has sustainably transformed our industry, creating new opportunities and challenges. At Sanofi, we are convinced that accelerating the innovation of mRNA technology means better vaccine accessibility for all populations, faster than before.
For this reason, we are looking for bold, optimistic collaborators for our new team at the mRNA Center of Excellence. We are investing €400 million in this brand new center, where 400 employees dedicated to this technology work.
This center of excellence is proof of our commitment to the development and acceleration of vaccination and research resources with the R&D, digital and CMC teams.
The future of Sanofi depends on your ambition, your commitment. Join.
Intro about the position
About the Opportunity
This mRNA Center of Excellence (CoE) Analytical Development (US Waltham), Analytical Sciences, is seeking an Analytical Development/Quality Control (AD/QC) Operations Manager to lead activities in daily operations, encompassing method development, validation, transfer, QC release and stability, as well as process development support for mRNA vaccines development.
Key responsibilities for position
About growing with us for winning with us
In this position you will
Coordinate and manage detailed analytical development activities internally and externally with CROs by driving program-related tasks towards completeness and meeting timeline.
Follow up with program-related tasks, including but not limited to activities related to analytical method validation/verification, transfer, release and stability testing, investigations, logistic operations, and communication.
Coordinate and manage early development phase QC (GXP) activities with several internal groups of Analytical Sciences department and with CROs.
Coordinate AD/QC activities with multiple departments for different internal vaccine programs and with CROs.
Monitor CRO work progress, budget and FTEs, escalate any delays and discrepancies in operations.
Manage analytical development database and align with manufacturing and process databases.
Managed laboratory instrument purchase, calibration, and maintenance, as well as data archive.
Establish analytical development laboratory operational procedures.
Competencies / Requirements for position
BS/MS in analytical chemistry, biochemistry, or biotechnology, or related field.
BS (8+) and MS with 5+ years of professional experience in the vaccine or pharmaceutical industry in analytical development or quality control.
Practical hands-on experience in common analytical techniques, such as HPLC, CE, ELISA or qPCR.
Practical knowledge of analytical development, including analytical method development, qualification, transfer, validation, release and stability testing needs.
Expertise in database management, e.g., Microsoft-based database management.
Project management and GXP experience is preferred.
Concise communication, written and presentation, skills.
Capable of negotiation and possess skills in conflict resolution and crucial conversations (within team and between functions)
Ability to work in a fast paced, matrix environment; agility to respond to urgent requests, and initiative to lead new tasks.
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.