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A Range of Possibilities

mRNA Global Bioprocess Engineer Head - VACCINES (All gender)

date posted 08/05/2022
contract type Full time
job id R2651954
location Waltham, MA;

«Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.»

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!

Join us!

About the Opportunity

In the framework of mRNA Process Industrialization for vaccine production, you will be in charge to manage a team responsible of assessing, selecting, designing the most robust technical solution (Process Equipment)

You will support implementation in the future facilities by taking into account industrial constraints: the scope covers starting material to final Drug Product manufacturing.

In this role, you and your team will be the Key interface between Process Development/Industrialization Team and Engineering & Manufacturing Teams for Process Equipment

ABOUT GROWING WITH US FOR WINNING WITH US

In this role you will

  • Manage direct day to day team constituted by Senior/Confirmed Bioprocess Engineers, and superior Technologists located in France
  • Be Accountable for Process Technology selection, assessment, design, and dimension (Equipment, consumables for Single Use Techno) for each step of process from USP, DSP, BioCatalysis, fermentation, formulation, microfluidic, Encapsulation and Fill & Finish
  • Lead the development and implementation of Models for manufacturing operations to support capacity analysis, production planning, batch scheduling, long range planning, Site Sourcing, COGM estimation
  • Provide overview of process performance & attributes (RMs supply origin, cost, capacity, process design, mass balance) to ease VIA industrial assessment & COGs calculation
  • Support VIA mRNA footprint definition and strategic Industrial Roadmap via delivery of overall mRNA process design, product design (Liquid, frozen, lyo, primary packaging, devices)
  • In the framework of Technology Transfer (internal or external), your team will support Drug Substance & Drug Product Industrial Leader included:
    • For preliminary studies, providing Equipment needed and their design (Specification, Mass Balance, Process Flow Diagram)
    • identifying and evaluating gaps between Receiving unit Equipment proposal and the need then, defining actions to bridge the gaps and/or mitigate risks
    • For studies and Execution, supporting Engineering team (Internal or External) to review technical document (PID, Functional Analysis, Bill of Material), to challenge solutions, to ensure Tech Transfer success

  • For Process transfers to Evolutive Vaccine Facilities, you will be involved in the development of standardized modules, to anticipate evolution
  • Be a catalyser for Technology Innovation; Analyse overall Technology Landscape and manage internal or external development in collaboration with mRNA Center of Excellence Research & others CMC Platforms: Techno watch, Scouting, contractual part management, Intellectual Property, assessment, and implementation
  • Lead process Unit operation Modelling to design and support Scale up, Scale Down Model representativity, Process characterization, in the frame of external collaboration (academic, specialized companies)
  • Active member of internal or external Process Technology/Innovation Network (VITA)
  • You will support Generic Platform implementation & deployment by standardizing at maximum equipment for large Scale development and generate Process Standards for mRNA Platform
  • Lead & Deploy PAT (Process Analytical Technology) Roadmap for the mRNA Center of Excellence
  • Support Digitalization roadmap

Scope and dimensions

  • Breadth of responsibility (global/regional/country/site): Cooperation with multiple entities global and local (Research & Development, Industrialization, Engineering teams)
  • Manage Team in France and US
  • Key dimensions: Largest Project (> 800 M€). Drives process techno innovation
  • Freedom to act, level of autonomy: Numerous levers to develop and implement new technologies. Innovative paths to be imagined, get endorsed, executed

ABOUT YOU

Qualifications/Education & Work experience

  • BS or Master's Degree in Biotechnology engineering
  • 15-20 years' experience
  • Experience in Technical Senior Team Management 
  • Expertise in biotechnologies ideally from entities geared towards innovation and agile development
  • Experience in Engineering and industrialization
  • Strong technical background on flexible biotech processing, USP, DSP, Formulation, Fermentation Biocatalysis, Single Use Technologies, Process Analytical Technologies, Fill and Finish, Lyophilization
  • Pragmatism, curiosity, agility
  • Strong leadership
  • Process Modelling experience is a plus
  • Capacity to manage external collaboration
  • Ability to work transversally in complex organizations
  • Fluent in English

#mRNA

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.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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