Large Scale mAbs Engineering Project Head

SanofiFramingham, MA
$232,500 - $335,833Hybrid

About The Position

The Engineering Project Head will lead the Large Scale mAbs project and be responsible for coordinating all activities associated with the setup of the new drug substance manufacturing building. The Project lead will be responsible for early enabling works, permitting, and constructability reviews before taking the project through BOD, DD, Construction, Commissioning and Qualification and Handover. He/she represents the Global Engineering in the overall project, working in very close collaboration with the Site team. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Requirements

  • Degree in Life Sciences, Engineering, or Biotechnology
  • > 10 years experience in Project Management including management of large projects >€1 Billion
  • >10 years of large teams’ management experience (+100 people)
  • Broad industrial experience in the pharmaceutical business (>10 years)
  • Experience in multi-site operations, global projects and matrix management.
  • Thorough knowledge of cGMP and regulatory requirements.
  • Demonstrated ability to build highly performing teams.
  • Strive for results and ability to make decisions in a complex and high speed environment
  • Intercultural experience
  • Excellent communication skills
  • Ability to influence and build strong relationships with internal and external partners.

Responsibilities

  • Providing overall leadership and direction to the Project team, ensuring the manufacturing facility and equipment are properly designed, installed, qualified, maintained, and processes properly validated.
  • Ensuring all Safety & Quality Standards, as well as Regulatory commitments, are met with the highest standards of quality.
  • Oversight of all Engineering, Automation, Maintenance and C&Q activities
  • Ensuring on-time/on-budget execution of the project.
  • Ensuring project risks are properly identified, followed-up and reported, and that mitigation plans are implemented.
  • Ensuring the building delivered complies with the performance targets committed in the SPE.
  • Building and executing Manufacturing staffing and training plans along the project execution and running operations.
  • Preparing and supporting strategic workforce planning.
  • Preparing and supporting proper integration of the new facility within the legacy brownfield site.
  • Providing the Manufacturing schedule to support the project execution as well as the manufacturing ramp-up until routine activities are settled.
  • Contributing with MSAT to the optimal process definition for new equipment and facility to ensure process robustness, product quality and costs optimization based of the current production process analysis (equipment, organization).
  • CapEx management and COGs optimization are a must and the project head is accountable to deliver the most optimiun efficiency.

Benefits

  • high-quality healthcare
  • prevention and wellness programs
  • at least 14 weeks’ gender-neutral parental leave
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