Senior Global mAbs Manufacturing Project Lead

BioSpace; Swiftwater (Monroe County); On-site; USD 150,000 - 190,000; Full time

Job summary

Sanofi is seeking a Large Scale mAbs Engineering Project Head to lead the global scale-up program for a new drug substance facility in Swiftwater, PA or Framingham, MA. You will coordinate early enabling works, permitting, and constructability, guiding the project through BOD, DD, construction, commissioning and handover.

You will provide overall leadership to the project team, ensure safety, quality, and regulatory commitments, and work closely with site and manufacturing teams to meet schedule

Qualifications

• Degree in Life Sciences, Engineering, or Biotechnology.
• 10+ years of project management for large-scale projects.
• Experience managing teams of 100+ people.
• Extensive pharma industry and multi-site operations knowledge.
• Strong understanding of cGMP and regulatory requirements.
• Proven ability to build high-performing teams and influence partners.

Responsibilities

• Provide leadership to the project team, ensuring facility design, installation, qualification and validation.
• Ensure Safety, Quality Standards and Regulatory commitments are met at high standards.
• Oversee Engineering, Automation, Maintenance and C&Q activities.
• Ensure on-time and on-budget project execution.
• Identify and mitigate project risks with actionable plans.
• Deliver facility that meets SPE performance targets and ramp-up plan.
• Develop staffing and training plans for manufacturing operations.
• Integrate new facility with legacy brownfield site.
• Provide manufacturing schedule to support project execution and ramp-up.
• Collaborate with MSAT for optimal process definition and cost optimization.
• Manage CapEx and drive efficiency improvements.

Skills

Project management

Leadership

cGMP knowledge

Regulatory familiarity

Communication skills

Cross-functional collaboration

Multisite management

Intercultural experience

Education

Life sciences degree

Engineering background

Job description

Sanofi is seeking a Large Scale mAbs Engineering Project Head to lead the global scale-up program for a new drug substance facility in Swiftwater, PA or Framingham, MA. You will coordinate early enabling works, permitting, and constructability, guiding the project through BOD, DD, construction, commissioning and handover.

You will provide overall leadership to the project team, ensure safety, quality, and regulatory commitments, and work closely with site and manufacturing teams to meet schedule