Large Scale mAbs Engineering Project Head

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

Job title:

Large Scale mAbs Engineering Project Head

Location

Swiftwater, PA Swiftwater, PA or Framingham, MA

About The Job

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, youll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main 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.

About You

• 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.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.