Massachusetts Green Jobs

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 mRNA Analytical Development Head of Quality Control within mRNA Analytical Sciences Department, Center of Excellence (CoE) will be responsible for management of GxP testing at CROs as well as establishing a QC laboratory in support of Manufacturing for programs from preclinical to clinical phases.

Key responsibilities for position - About growing with us for winning with us

This position will oversee the QC function and support the development and implementation of GMP quality systems to ensure that Sanofi’s testing and control strategies are in compliance with Sanofi policies, US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials.

Key Responsibilities include but not limited to the followings.

• Lead a team of approximately 20 individuals, managing various aspects of QC functions. You will also be responsible for future recruitment, training, performance management, and professional development of Quality Control testing personnel.

• Responsible for establishing the QC GMP laboratory and operational systems at the Sanofi Waltham site, including instrument IQ/OQ/PQ, analytical transfer, SOPs readiness, laboratory operations system, sample and reference/reagent management, shipping, etc.

• Ensure all GMP testing is conducted in accordance with SOPs, compendia, approved methods, and policies and procedures of Sanofi and regulatory agencies.

• Provide oversight and guidance to internal and CROs GMP contract testing labs including but not limited to technical transfer, method qualification and validation as well as routine GMP testing (in process, lot release and stability testing, and reference standard maintenance and qualification).

• Also responsible for continuous monitoring of method performance, trending, investigation/OOS management, data integrity reviews.

• Ensures a science-driven, phase appropriate, and risk-based quality control strategies to support new development programs.

• Will support the portfolio of clinical development to ensure timely delivery of clinical batches results and will assemble, review and trend release, IPC, and stability data, generating reports.

• Participate in regulatory agency inspections, and assists in observational resolutions, as needed.

Qualifications:

• PhD degree in Analytical Chemistry, Biochemistry, Biology, or a related discipline with at least 10 years, respectively, of relevant industry experience.

• Demonstrated experience managing large QC teams as well as CRO management.

• Experience in deviation management, method validation and monitoring method performance is required.

• Experience in ICH guidelines on method Validation and QC policies and procedures is required.

• Background in statistical analysis of analytical data and stability studies is preferred.

• Ability and desire to work in a fast-paced working environment.

• Strong collaboration, team building, and communication skills.

• Independently motivated and detail-oriented with good problem-solving ability,

• Demonstrated effective time management skills.

• Sound judgment and commitment to ethical conduct.

Capabilities :

• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.

• Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.

• Effective Planning – Embedding discipline and thoroughness in our approaches.

• Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity; comfortable in a results-driven, highly accountable environment where you can make an impact.

• Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.

• Relationship Building – Builds productive working relationships across a diverse spectrum of people.

• Organizational Skills – Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.

• Leadership skills – Motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.

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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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, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !