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Head of Process Development & Expertise

Toronto, Canada

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Responsibilities

REFERENCE #:

R2546752

TITLE:

Head of Process Development & Expertise

LOCATION:

Toronto, Canada

  • The Toronto site has entered an exciting period of unprecedented projects volume. The Head of Center oF Expertise at Sanofi Pasteur (SP) Industrial Affairs is tasked to design an organization that will increase productivity within the operations by deploying excellence in MTEC ways of working (Problem Solving, SMS, Studies Design using DOE and QBD,..)
  • MTEC Toronto has designed a new organization structure in order to increase products and processes knowledge in operations and to support efficiently and pro-actively the B100 buildings – As a result of this organizational evolution, the scope of work for the Center of Expertise has expanded significantly in term of new expertise needed (Cleaning Validation, Singles used technologies, Critical Materials management, Continuous Process Monitoring, QBD) and in term of feasibility studies
  • This role is critical to sustain the production demand on the Toronto site before new B100 bulk building (Capex > 600m Euros) is fully registered for commercialization of products (planned in 2024)

SUMMARY :

Under the responsibility of the Senior Director MTech, the Center of Expertise platform Director provides executive direction, develops and implements short, medium- and long-term strategic plans to ensure that:

  • The Seed management activities operate according to plan with budget and to the procedure Q_0235165
  • The MTech lab complies and is managed in a way to follow the PHAC and Sanofi quality policies for a BSL2 working area.
  • The MTech lab provides efficient, reliable and timely support with associated know how for the studies having to be performed to support the projects and investigations managed by MTech.
  • The CoE promotes disruptive innovations to be implemented in the production so that to significantly improve yields, robustness, quality, conformity and competitiveness of the current processes utilized for production of the vaccines and biologics manufactured at the Pasteur Industrial sites through the guidance of the technical experts.
  • The other platforms receive key scientific support and expertise
  • The Cleaning Validation and CMM expertise for MTech is reinforced and provides the requested support

KEY ACCOUNTABILITIES:

1. Seed Management:

  • Assure Seed Manager activities operate according to plan within budget
  • Accountable for the physical availability, quality, biosafety and compliance of seed lots and cell banks to be used in current production needs and long-range production planning at the Toronto site
  • Act as deputy for Seed Manager

2. CoE and MTech Laboratory:

  • Maintain the MTech Laboratory with adherence to Sanofi Health & Safety Policies as well as PHAC ones
  • Maintain the MTech Laboratory with adherence to Sanofi Quality Policy
  • Implement new technologies to anticipate the future needs and promote more efficient studies execution (quality of results, speed of execution, productivity)
  • Promote the improvement of the scientific and technology expertise
  • Promotes pragmatic innovation for yield and robustness improvement
  • Promotes and build Global and regional networks
  • Key contributor for building new pilot labs

3. Cleaning Validation and CMM:

  • Ensure timely and strong CV activities
  • Establish and maintain close connection with Project MTech Leaders, Manufacturing and Quality teams
  • Ensure capability for effective root cause investigation and deviation assessment
  • Support inspection activities
  • Strengthen CV process
  • Strengthen CMM strategy and execution

4. Team management:

  • Maintain and reinforce strong scientific and technical skills
  • Lead, Motivate and develop people of the teams
  • Attract/retain best talents
  • Influence APU leads (Senior Directors) and Quality Operations Lead (senior Directors)
  • Strong partnership with Head of Manufacturing Assistance lead (Directors), Programs Lead (Directors and Deputy Directors) and Data Science (Director and Deputy Directors

Scope

  • Manufacturing/QC assistance at site level, Project portfolio for multiple sites and R&D, pasteur and group
  • Interact on a regular basis with Global Expert Network to influence future regulations
  • IPV, D, T, 5cP and NV bulk Manufactruring process support at all site level
  • Formulation Lab
  • 25-35 RHC (Internal & External)
  • Capital investment : 5-10M$
  • Program : 4-8 Major PPI projects; Compliance status of activities related to cP, D & T, NV Product/Process performance in respect to yield, robustness, cost and quality
  • Freedom to act, level of autonomy:
  • Leads and manages the activities of the paltform. Development and allocation of staff to projects, proposal of manufacturing process and changes, establishment and execution of appropriate methodologies and tools for design/verification/ control process. High level of autonomy within the Toronto Site

REQUIREMENTS:

Education/Certifications:

  • Master or PhD in Biotechnology or other relevant discipline

Experience:

  • 15 years, direct experience in pharmaceutical/ biotechnology manufacturing or process industrialization
  • Very Good knowledge of vaccines processes/products
  • Key technical competencies and soft skills:
  • Recognized as subject matter expert (SME) in industrial upstream (bacterial culture) is a Must Have
  • SME in downstream is an asset.
  • Risk assessment, root cause investigation, strong analytical mindset, understand the technical aspects of all units of operations (for seed production and security), understand RA requirements
  • Communicate transversally at all levels of the organization, negotiation, facilitation, team motivation, team management, empowerment, emotional Intelligence
  • Leadership and soft skills, including team creation & development, strategy setting and execution, vision creation and alignment, conflict resolution, critical thinking, problem solving, influence and collaboration
  • Has technical experience making it possible to identify critical information not recorded, understand its impact on production outputs and formalize the technical knowledge and potential innovation topics
  • Able to challenge the experts in a constructive way to improve products and processes knowledge (SPP, subject matter experts…)

CANADA – Sanofi Pasteur

Sanofi Pasteur: The world’s leading vaccine company

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.  Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.  Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Sanofi, Empowering Life

#GD-SP #LI-SP

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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