mRNA Manufacturing Sciences Lead GMP Investigator

mRNA Manufacturing Sciences Lead GMP Investigator

Location: 200 West St, Waltham, MA

≤40% Remote working and <20% of travel expected

Job type: Permanent, Full-time

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!

ABOUT THE JOB

Our Team:

The External Manufacturing and Manufacturing Sciences (EMMS) team is part of the cGMP Strategic Supply and Operations functional area of Sanofi’s mRNA Center of Excellence.  The EMMS team provides end to end service by owning the technology transfer and managing external production of custom raw materials, drug substance, drug product material used in late phase clinical studies.  The EMMS team is also responsible for the management of GMP product and process data, raw materials attribute data, and batch contextual data to provide accessibility to a structured data set for analysis to help with investigations and feed-back into the manufacturing process for improvement. 

MAIN RESPONSIBILITIES:

As the Manufacturing Sciences Lead GMP Investigator, you will be responsible for leading cross functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations on corrective actions for deviations and GMP Investigations of varying complexity.  You will provide investigative leadership and work with internal and external Subject Matter Experts (SMEs) to close deviations and GMP investigations to facilitate lot disposition at our CMO partners producing custom raw materials, drug substance, and bulk drug product.

You will work with cross-functional internal and external functions on managing and implementing appropriate corrective and preventative actions that are recommended by investigative teams.  Internal contacts include Manufacturing, Quality, Process Development, Engineering, Data Sciences, Supply Chain, Data Management.  External contacts include contract manufacturing organizations and raw material suppliers.

Responsibilities will include, but are not limited to:

• Management of cross-functional teams to drive deviation investigation closeouts, determine root cause and implement appropriate Corrective and Preventative Action

• Utilization of manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and continuously improve process operations

• Conduct document revisions and/or document management including batch production records, manufacturing procedures, and cross-functional procedures

• Utilization of data to make science-based decisions in the determination of root cause analyses of manufacturing deviations

• Working with manufacturing managers, supervisors, engineers, and scientists to develop and maintain training materials and curricula on process operations, theory, and compliance

• Working with external raw material suppliers to manage and perform cGMP Investigations, troubleshoot potential issues, and assisting with the implementation of process improvements.

• Performing troubleshooting and investigations with staff on the manufacturing floor and supplier manufacturing facility, as needed

• Leading cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, External Manufacturing, Raw Materials Team, Supply Chain, and Manufacturing Sciences.

• Working independently with minimal supervision and direction.

• Effectively utilizes Microsoft office applications

• Creates and presents trending and metrics reports

• Assuming additional responsibilities as assigned

ABOUT YOU

• Experience: Minimum 10 years industry experience

• Soft skills:

  • Ability to facilitate meetings with cross functional teams in person and virtually

  • Excellent written and oral English language skills

  • Experience with Microsoft office applications

  • Experience with root cause analyses methods such as fishbone, PEMME, Five Whys, Pareto Chart, Scatterplot, Diagrams and when to appropriately apply methods

  • Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.

• Technical skills:

  • Experience with troubleshooting, investigation, and root cause determination as it relates to exceptions in GMP manufacturing

  • Demonstrated knowledge / understanding of manufacturing process

  • Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations

  • Experience with deviation management and implementing corrective and preventative action (CAPA)

  • Experience with using quality management systems to document manufacturing exceptions, CAPA, and change controls

  • Understanding of product and process manufacturing data and how to perform analysis to support root cause determination

• Education: BS / MS in Life Sciences or Engineering

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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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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.