Lead, Large-Scale mAbs Manufacturing Project

Sanofi; Framingham (MA); On-site; USD 220,000 - 280,000; Full time

Job summary

Sanofi is seeking an Engineering Project Head to lead the Large Scale mAbs project in the Framingham, MA area. The role will coordinate the setup of a new drug substance manufacturing building, oversee enabling works, permitting, and constructability reviews, and drive through through qualification and handover with the Global Engineering team.

You will manage multi-site operations, ensure regulatory compliance, and build a high-performing, diverse project team in a fast-paced environment.

Qualifications

• Degree in Life Sciences, Engineering, or Biotechnology.
• 10+ years of Project Management experience including large-scale projects (>€1 Billion).
• 10+ years leading large teams (>100 people).
• 10+ years in the pharmaceutical industry.
• Experience in multi-site operations, global projects and matrix management.
• Thorough knowledge of cGMP and regulatory requirements.
• Proven ability to build high-performing teams.
• Strong results orientation and decisive in fast-paced environments.
• Intercultural experience.
• Excellent communication and relationship-building with internal/external partners.

Responsibilities

• Provide leadership to the Project team ensuring facility and equipment are designed, installed, qualified, maintained, and processes validated.
• Ensure Safety & Quality Standards and Regulatory commitments are met.
• Oversee Engineering, Automation, Maintenance and C&Q activities.
• Ensure on-time/on-budget execution of the project.
• Identify and mitigate project risks; report and implement mitigation plans.
• Ensure the building delivers performance targets in the SPE.
• Develop staffing and training plans for manufacturing along the project execution and ramp-up.
• Support strategic workforce planning.
• Integrate the new facility within the legacy brownfield site.
• Provide Manufacturing schedule to support project execution and ramp-up.
• Collaborate with MSAT on process definition for new equipment and facility.
• Manage CapEx and COGs optimization; deliver efficiency.

Skills

Project management

Leadership

Regulatory knowledge

Communication

Intercultural experience

Education

Degree in Life Sciences, Engineering, or Biotechnology

Job description

Sanofi is seeking an Engineering Project Head to lead the Large Scale mAbs project in the Framingham, MA area. The role will coordinate the setup of a new drug substance manufacturing building, oversee enabling works, permitting, and constructability reviews, and drive through through qualification and handover with the Global Engineering team.

You will manage multi-site operations, ensure regulatory compliance, and build a high-performing, diverse project team in a fast-paced environment.