IM PD Bio-Therapeutics Technical Lead

Role Summary

The Bio-Therapeutics Technical Lead provides expert engineering technical support and guidance in facility design, construction, commissioning and process validation for green field and brown field Drug Substance and Drug Product facilities. Key responsibilities include defining and deploying a vision and strategy for a standard Facility and Equipment design for IM capital projects, overseeing the design and creation of Facility and Equipment processes and standards to ensure a safe, compliant transition from project build to start-up, and keeping abreast of current industry and regulator standards to ensure facilities meet leading-edge requirements. The role works across project teams and site engineering to ensure integration and seamless handover to operations.

Responsibilities

• Keep abreast of all current industry and regulatory standards and trends to ensure IM Bio-Therapeutics plants are designed, built and commissioned to leading edge standards.
• Define and deploy a vision and strategy for a standard Facility and Equipment design for IM Bio-Therapeutics capital projects.
• Oversee the design and creation of Facility and Equipment processes and standards to ensure safe, compliant transitions from project build to start-up.
• Develop new engineering standards for facility design for Bio-Therapeutics.
• Provide expert engineering technical support in facility business need, design, construction, commissioning and process validation for green field and brown field Drug Substance and Drug Product facilities.
• Nurture future talent by mentoring internal and external engineers.
• Collaborate with the Global Engineering Technology (GET) team to align with technology standards and project execution.
• Ensure compliance with policies, procedures, government regulations, and customer specifications.
• Proactively research and implement new standards to drive growth and efficiency.
• Report to senior management on activities and status.

Qualifications

Education

• A minimum of a Bachelor's engineering degree is required; Master's/MBA/PhD is preferred.

Required

• A minimum of 15 years of manufacturing, project engineering, supply chain and capital project execution in the Bio-Pharmaceutical industry.
• Hands-on experience designing, constructing, commissioning or qualifying manufacturing process equipment.
• Strong Bio-Pharmaceutical Drug Substance and Drug Product process engineering expertise, including experience with Annex 1.
• Large capital project management experience over $250 million.
• Ability to balance multiple priorities and communicate effectively in a high-profile environment.
• Fluent in written and spoken English.
• Travel of at least 25% domestically and internationally.
• Hybrid work environment (remote and in-office).

Additional Requirements

• Note: Role may be posted under multiple requisition numbers to align with local requirements; applications across locations may be consolidated.