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Senior Manager External Manufacturing and Supply

Waltham, Massachusetts

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Overview

From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.

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Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Leadership
  • Proactive
  • Problem-Solver
  • Results-driven
  • Team player

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Culture: Play to Win

  • Woman looking through a microscope

    Growth

  • Scientists discussing lab work

    Innovation

  • Doctor using new technology

    Efficiency

  • Woman using dry eraser marker drawing up business plans on glass

    Collaboration

Benefits

  • Health & Wellness

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

  • Financial

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

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    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

POSITION OVERVIEW / DEPARTMENT DESCRIPTION

The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best in class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products.   Sanofi is looking for an experienced External Manufacturing and Sourcing professional with experience in procurement, contract management and external sourcing to join the Genomic Medicine External Manufacturing and Supply organization in Sanofi in the role of Operational Business Support Manager. The Genomic Medicine External Manufacturing and Supply group within Sanofi is responsible for oversight and management of outsourced non-clinical and clinical Drug Product, Drug Substance and certain critical start and raw material Manufacturing and/or supply for Sanofi’s genomic medicine pipeline . 

The successful applicant will be in charge of CDMO Management activities with assigned external partners, working with and supporting all cross-functional groups to ensure the seamless supply of externally manufactured products and critical raw materials.

We are looking for a candidate with an innate ability to collaborate and build relationships and excellent influencing, negotiation and project management skills.  

KEY RESPONSIBILITIES

  • Act as first/primary point of contact for all Sanofi  interests/activities at assigned Contract Development Manufacturing Organizations (CDMO)

  • Maintain operational oversight of, and troubleshooting support to, CDMO to ensure all deliverables meet or exceed Sanofi requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management)

  • Act as Liaison with internal and CDMO stakeholders on business operations including but not limited to contract management, forecast communication, issuance of POs and reconciliation/validation of invoices

  • Leverage technical, quality and regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables.

  • Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.

  • Work closely with CDMO and internal CMC, Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations and deviations)

  • Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs. Establish a robust tracking and reporting process to ensure compliance with KPI’s, internal/external audit observation deadlines or other regulatory commitments

  • Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity

  • Support CDMO selection process by coordinating/facilitating RFP generation

  • Support New Product Introduction and Technical Transfer teams by facilitating CDMO interactions

  • Drive effectively internal processes, identify bottlenecks and proactively resolve issues

  • Lead continuous improvement initiatives to affect timely resolution of supply issues

BASIC QUALIFICATIONS

  • Master’s degree in Medical, Life Science or related with a minimum of 8 years of relevant experience or a Bachelor’s degree with a minimum of 10 years of relevant experience

  • 5+ years of experience in Cell- and/or Gene Therapy/Vaccine/Biologics Drug Development and/or Manufacturing

  • Experience in Project Management working with virtual global teams

  • Experience in Technology Transfers and new product launches

  • Experience in managing suppliers and CDMOs / CROs within the pharmaceutical industry

  • Able to communicate at the senior and operational level, both internally and externally

  • Able to think critically to make strategic and/or tactical decisions to support the business and ensure the continuous supply

  • Self-starter, results-oriented, and able to prioritize the tasks

  • Able to influence and negotiate internally and externally

  • Able to effectively manage complex network  of internal/external stakeholders and decision makers

PREFERRED QUALIFICATIONS

  • Understanding of the Cell- and or Gene Therapy drug development and manufacturing processes, of relevant cGMP requirements, and knowledge in the manufacturing of sterile solutions and suspensions

SPECIAL WORKING CONDITIONS

  • Ability to travel, national and international, up to 25%

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

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.

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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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