Mrna Manufacturing Data Entry Clerk - Vaccine

Success Profile

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.

Watch our Jobinar’s replay (https://sanofi12.jobinar.com/) to discover more about the ongoing work at our Center of Excellence.

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!

OUR TEAM:

As part of the Manufacturing Sciences team within cGMP Strategic Supply and Operations, the Manufacturing Data Entry Clerk will be responsible for assisting with the organization, entry, review, verification, and loading manufacturing data from an unstructured format into a structured data management system. Source document for data will primarily be pdf documents.

This role will contribute to the GMP Strategic Supply and Operations functional area goals within the mRNA Center of Excellence (CoE).

Main duties will include the curation, entry, verification, and reconciliation of data into appropriate data management systems for raw material attributes, manufacturing in-process data, and product data. Additional responsibilities will include providing data outputs in useful formats to cross-functional teams to allow for visualization, reporting, and analysis. Datasets will include batches that are manufactured both at internal sites and external contract manufacturing facilities.

The individual will be responsible for ensuring data is entered and verified in the data management systems in a timely manner, adhering to master data standards, and maintaining data integrity.

MAIN RESPONSIBILITIES:

• Follow GMP procedures for data entry and verification log sheet completion
• Manual data entry and verification of batch release data and product stability from source documents (usually pdf) into data management system
• Partner with cross functional teams to ensure entered data adheres to master data standards
• Highlight and escalate data inconsistencies upon discovery
• Verification and reconciliation of entered data against source documents
• Data entry and verification of batch metadata (date of manufacturing, manufacturing site, scale, batch type, etc.)
• Support the identification and implementation of new data systems and interfaces
• Manual data entry and verification of manufacturing process data from paper batch records into data management system
• Collaboration with other functions within the mRNA CoE to ensure data standards are understood and followed
• Data entry and verification of raw material batch attribute data into data management system
• Assume additional responsibilities as assigned

ABOUT YOU:

• Basic understanding of modern database, manufacturing systems, and information technologies
• Ability to work independently and effectively
• Understanding of data administration duties such as curation, analysis, and visualization
• Results oriented and demonstrated focus on achieving (business) results
• Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication. Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support scientific and business goals
• Highly organized, exceptional attention to detail, and strong proficiency in documentation skills
• Preferred: Bachelor’s degree in the Sciences or Engineering
• Familiarity with current issues and requirements around data integrity, as required by the federal agencies related to pharmaceutical development and cGMP manufacturing
• Experience working with Microsoft Office tools (Excel, Word) and/or data management systems
• Experience: 2-5 years of relevant experience in the Pharmaceutical, Biopharmaceutical, or Biotech industries
• Ability to prioritize and deliver on tight timelines
• Experience with data management systems and good data management practices

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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#mRNA

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.