Senior Lead, Large-Scale mAbs Engineering Project

Eacademy Sanofi; Framingham (MA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Gender-neutral parental leave (14+ wks

Healthcare benefits

Global mobility and international work

Job summary

Sanofi is seeking a Large Scale mAbs Engineering Project Head to lead the multi‑disciplinary project team for a new drug substance manufacturing facility. You will coordinate early enabling works, permitting, constructability reviews, and drive the project through BOD, DD, Construction, Commissioning and Handover, in collaboration with the Site team.

The role demands >10 years in large pharmaceutical projects, multi-site operations, and strong cGMP knowledge, with a focus on delivering on

Qualifications

• Degree in Life Sciences, Engineering, or Biotechnology.
• Thorough knowledge of cGMP and regulatory requirements.
• Demonstrated ability to build highly performing teams.
• Intercultural experience and excellent communication skills.

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 optimal efficiency.

Skills

Communication skills

Influence & relationships

Intercultural experience

Decision making in fast environment

Team leadership

Education

Degree in Life Sciences, Engineering, or Biotechnology

Job description

Sanofi is seeking a Large Scale mAbs Engineering Project Head to lead the multi‑disciplinary project team for a new drug substance manufacturing facility. You will coordinate early enabling works, permitting, constructability reviews, and drive the project through BOD, DD, Construction, Commissioning and Handover, in collaboration with the Site team.

The role demands >10 years in large pharmaceutical projects, multi-site operations, and strong cGMP knowledge, with a focus on delivering on