mRNA Raw Material CRO Manager - Vaccines
mRNA Raw Material CRO Manager - Vaccines
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mRNA CoE Analytical Development RM QC Manager
Location – Waltham, MA US
In the race for the future of health – The Sanofi mRNA Center of Excellence (CoE)
At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before.
That’s why we’re looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.
Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!
Intro About the Position
About the Opportunity
The analytical development RM QC manager within mRNA Center of Excellence will be responsible for focused on management of CROs for raw material testing supporting Analytical Development CMC activities for preclinical through late-stage development programs. The ideal candidate will have relevant experience and a track record of accomplishments in the life sciences/ pharmaceutical/biotechnology industry.
The analytical development RM QC manager will support both internally within Sanofi Analytical Science US site and externally at CRO for various analytical CMC activities.
Key Responsibilities for Position
About growing with us for winning with us
In this role you will….
Collaborate with the RM leader, Stability Manager, SME and other project managers to align timelines and ensure milestones for analytical activities are met. Manage CRO notifications.
Manage CROs where the analytical testing, methods development, qualification and validation are performed. Ensure analytical data, CoAs, and reports available from CRO in time;
Support Sample shipment management purchase order, SOW and invoice management with CROs as required.
Support RM (Raw Material) leader with definition of testing profile;
Lead CRO Release and Stability testing and other GMP activities including Change control, deviation, OOS investigation and ensure proper CAPA implemented.
Planning, initiation, execution and tracking of project activities. Proactively monitor project progress and provide timely communications to the leadership team.
Ensure trending of release data and collaborate with stability manager for stability testing at CROs
Follow up on compendial methods update.
Organize internal and external meetings for RM related issues whenever necessary.
Assist with analytical testing investigations at CROs.
Competencies / Requirements for position
Qualifications/ Education & Work Experience
BS (10+) or MS (7+) years of relevant experience in the biopharmaceutical or CRO industry.
BS or MS degree in chemical, biomedical, biochemical, or process engineering, chemistry, materials sciences, or formulation sciences, coupled with an understanding of analytical chemistry.
Technical bench experience in analytical development or QC testing and/or hands on experience with Compendial methods, CE/CGE, HPLC, PCR, ELISA, and gel electrophoresis etc. is preferred.
Excellent organizational skills with great attention to detail.
Strong interpersonal skills, self-awareness and ability to manage team dynamics.
Strong written and oral communication skills, with some experience managing cross-functional communication.
Strong and collaborative work ethic. Results oriented and demonstrates a focus on achieving (business) results.
Ability to facilitate meetings, enhance team communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
Knowledge and understanding of laboratory terminology, good documentation, and good laboratory practices.
Excellent knowledge with all aspects of MS Office including MS Project and Visio, Sharepoint and MS Teams.
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.
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