Large Scale mAbs Engineering Project Head

BioSpace; Swiftwater (Monroe County); On-site; USD 200,000 - 280,000; Full time

Job summary

Sanofi is seeking an experienced Large Scale mAbs Engineering Project Head to lead the global Large Scale mAbs project, coordinating setup of a new drug substance manufacturing building and overseeing enabling works, permitting, and constructability reviews through construction, commissioning, and handover.

You will represent Global Engineering, collaborating closely with site teams and MSAT to optimize processes, ensure quality and COGs targets, and deliver on-time, on-budget execution in a

Qualifications

• Degree in Life Sciences, Engineering, or Biotechnology.
• >10 years experience in Project Management including management of large projects (>1B).
• >10 years of large teams management experience (>100 people).
• Broad industrial experience in the pharmaceutical business (>10 years).

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

Intercultural experience

Excellent communication skills

Ability to influence

Education

Degree in Life Sciences, Engineering, or Biotechnology

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

From project execution phase up to routine manufacturing, LSM Engineering Project Head is responsible for:

• 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 affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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.