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Manager, CMO Management, Custom Reagents - Vaccine

Waltham, Massachusetts

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Overview

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

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    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

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!

Our Team:

As part of the External Manufacturing team within cGMP Strategic Supply & Operations, the experienced Manager will be responsible for leading cross-functional teams to manage Raw Material CMO relationships, Tech Transfers, oversight of production runs, closure of Quality events, and disposition of product.  These CMOs produce GMP grade critical reagents and custom raw materials / excipients used in the manufacturing of novel mRNA and mRNA Lipid Nanoparticle vaccines and therapeutics. These materials include custom plasmids, critical enzymes, reagents, and custom lipids.  This role will contribute to the CMC strategy and external manufacturing execution within the mRNA Center of Excellence (CoE). 

This individual should have knowledge of traditional biologics manufacturing processes as well as plasmid and small molecule lipid production.  This includes cell line selection, establishing master and working cell banks, upstream cell culture, downstream purification, process chemistry, and analytical characterization.  They should also have an understanding of working in an FDA regulated environment and producing materials under cGMP’s for human use.  Finally, the successful candidate should be experienced in managing projects and cross-functional teams to deliver on production targets.

Main responsibilities:

  • You will serve as the main point of contact with Sanofi’s network of Custom Raw Material CMOs to:

    • Lead cross-functional teams to address actions and issues as they arise in CMO relationship management

    • Oversee production runs and disposition of product to fill the orders placed by the Supply Chain Team

    • Manage closure of Quality events (deviations, investigations, Vendor Change Notices, etc.) engaging cross-functional support (Raw Materials group, Technical SMEs, QA, etc.) as required

    • Oversee & manage Tech Transfer of Custom Raw Material production processes from internal or external sources to new CMOs

  • Organize and facilitate Gantt charts development and manage timelines, particularly critical path items. Develop and maintain project charters, RACI matrices, and resource trackers.

  • Lead internal project teams through issuance of meeting agendas, facilitating regularly scheduled meetings, issuance of minutes, tracking action items, etc. Control and track information exchange with other internal groups and external collaborators as needed.

  • Work closely with CoE Raw Materials Program Lead to execute on outsourcing strategy for critical custom reagents.  This will include vendor identification, evaluation, selection, and qualification while ensuring alignment with drug substance and drug product timelines

  • Work closely with lead technical representatives to ensure critical raw materials are manufactured to phase-appropriate technical and regulatory specifications

  • Review and approve CMO batch records to ensure cGMP quality standards are met to facilitate product disposition

  • Work closely with lead technical SMEs to provide technical support, resolve scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality.

  • Work with Analytical Sciences to ensure that characterization, including stability, of critical reagents and custom raw materials is comprehensive

  • In collaboration with the CMO Strategy team, review and edit contracts, supply agreements, statements of work, etc.

  • Support and contribute to IND and IMPD filings as well as other regulatory documentation

  • Assume additional responsibilities as assigned

About you

  • A bachelor's or master’s degree in Molecular Biology, Biochemical Engineering, or a related field.  PMP certification is highly desirable, but not required

  • 8+ years of relevant experience in the Pharmaceutical, Biopharmaceutical, or Biotech industries

  • Ability to work independently and effectively.

  • Strong problem-solving abilities.

  • Ability to prioritize and deliver on tight timelines

  • 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.

  • Results oriented and demonstrates a focus on achieving (business) results.

  • Knowledge and experience with GMP production of plasmid DNA, custom enzymes, custom lipids, and associated purification processes.

  • Expertise in establishing cGMP compliant Working and Master Cell Banks.

  • Experience in vendor search, evaluation, selection, and management.

  • Strong familiarity with cGMP and ICH Guidelines (including Q7A, Q11).

  • Uses leading-edge knowledge of Project Management principles, concepts, and practices to lead complex projects within a department team.

  • Ability to travel (domestic and international) ~25% of time, particularly when production campaigns are being done.

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

#mRNA

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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.

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