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Head of Drug Substance Manufacturing Biologics US

Framingham, Massachusetts

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Overview

This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.

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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

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

The Position

Sanofi is looking for an accomplished GMP drug substance manufacturing professional focusing on producing clinical supplies for biologics to be the head of the Drug Substance Manufacturing Biologics Group located in Framingham, MA.  Our facility in Framingham is part of the Global Drug Substance Manufacturing Biologics group within Sanofi and operates with the mission to deliver drug substance for clinical trials from Phase I to Phase III of Sanofi’s very diverse early and late-stage biologics pipeline.

We are looking for a candidate with excellent GMP, scientific & technical, communication, and leadership skills. Our facility in Framingham is unique to house both fed batch and elements of intensified continuous manufacturing. The candidate will be expected to develop strategy, plan and execute implementation of advanced manufacturing technologies (in fed batch as well as continuous or integrated processes). In addition, as a senior leader of the Biologics Development Framingham organization, he/she is expected to work collaboratively and transversely with other leaders throughout the global network to establish objectives, priorities and directions, and also represent the function in stakeholder meetings.

Responsibilities

  • Lead a skilled group of Process Engineers, Technicians and Operators in upstream as well as downstream processing within a global GMP manufacturing organization.
  • Provide safe, effective and GMP compliant drug substance for clinical studies acc. to project timelines and needs.
  • Build and foster strong interfaces to global partner groups in France, Germany and the U.S. as well as collaborators in Cell Culture and Purification Process Development, BioAnalytics, Formulation and Industrial Affairs groups.
  • Develop and implement site specific long range as well as strategic planning including the realization of strategic projects.
  • Ensure effective  resource management within CAPEX, OPEX and staff.
  • Look for ways to improve effectiveness utilizing change management tools
  • Manage talent and people development within the organization.
  • Support the creation of high-quality CMC documentation for regulatory authorities and knowledge management.

Basic Qualifications 

  • PhD degree in Biotechnology, Bioprocess Engineering or Chemical Engineering or related field with a minimum of 12 years of relevant  experience or Master’s degree  with a minimum of 16 years of relevant  industrial experience
  • Experience in managing a team (either within a line function or a cross-functional project team).
  • Experience in executing complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.
  • Experience with  GMP regulations, a broad understanding of process sciences, mammalian cell cultures, protein chemistry and biochemistry.
  • Extensive experience in compliance and GMP manufacturing with a proven track record in health authority quality audits.
  • Strong skills in change management.
  • Excellent communication skills

Preferred Qualifications

  • Experience in the biotech/pharmaceutical industry within commercial manufacturing of biologics based on mammalian cell culture
  • Experience in continuous manufacturing processes.
  • Experience with LEAN principles
  • Experience leading change initiatives

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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#LI-SA

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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