Associate Manager, Cmo Management, Custom Raw Materials - Vaccine

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 Raw materials team within cGMP Strategic Supply & Operations, the manager will be responsible for leading cross-functional teams to manage Custom Raw Material CMO relationships, oversight of production runs, closure of Quality events, and disposition of product. These CMOs produce GMP grade Custom Raw materials / excipients used in the manufacturing of novel mRNA and mRNA Lipid Nanoparticle vaccines and therapeutics. These materials include plasmids, critical enzymes, 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 ideally a knowledge of traditional biologic/chemical manufacturing processes as well as plasmid and/or small molecule lipid production. This includes cell line selection, establishing master and working cell banks, upstream cell culture, downstream purification, organic 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 support Customs Raw materials CMO manager activities, being the main point of contact with Sanofi's network of Custom Raw Material CMOs to:
  
  • Lead cross-functional project 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 if relevant of Custom Raw Material production processes from internal or external sources to new CMOs
• Other tasks might be to help on:
  
  • Ensuring that NDA, contracts, supply agreements, initial statements of work are in place, etc. in collaboration with the CMO Strategy team,
  • Work closely with CoE Raw Materials Program Lead to execute on outsourcing strategy for critical Custom Raw materials. 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
  • 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.
  • Update Gantt charts and project charters, RACI matrices, and resource trackers.
  • Support 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.
  • Support organization review and approve CMO batch records to ensure cGMP quality standards are met to facilitate product disposition
  • Work with Analytical Sciences to ensure that characterization, including stability, of critical Raw materials and Custom Raw materials is comprehensive
  • Support and contribute to IND and IMPD filings as well as other regulatory documentation
• Assume additional responsibilities as assigned

About you:

• Bachelor's or Master's degree in Biology or Chemistry, or a related field.
• 8+ years of relevant experience in the Pharmaceutical, Biopharmaceutical, or Biotech industries required
• Project Management experience required
• PMP certification will be a very strong plus
• Knowledge ideally with GMP production of plasmid DNA, custom enzymes, custom lipids, and associated purification processes.
• Experience in vendor search, evaluation, selection, and management.
• Strong familiarity with cGMP and ICH Guidelines (including Q7A, Q11).
• Ability to work effectively and autonomously,
• 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.
• Ability to travel (domestic and international) ~max 10% of time, particularly when production campaigns are being done.

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.
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.