IM PD Bio-Therapeutics Technical Lead

Role Summary

Innovative Medicine Project Delivery ATMP Technical Lead. The Bio-Therapeutics Technical Lead provides expert engineering leadership in facility design, construction, commissioning and process validation for Drug Substance and Drug Product facilities, guiding standard facility and equipment design across IM capital projects. Responsible for ensuring safe, compliant, and reliable transitions from project to operations and keeping abreast of current industry and regulator standards.

Responsibilities

• Keep abreast of current industry and regulatory standards and trends to ensure IM Bio-Therapeutics manufacturing 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 smooth transition from project build to start-up.
• Develop new engineering standards for facility design for Bio-Therapeutics.
• Provide expert engineering technical support in facility needs, design, construction, commissioning and process validation for Drug Substance and Drug Product facilities (greenfield and brownfield).
• Nurture future talent by mentoring internal and external engineers.
• Collaborate with GET team head to align technology standards and engineering specifications for manufacturing technology.
• Ensure compliance with policies, regulations, and customer specifications.
• Proactively research and implement new standards to drive growth and efficiency.
• Report regularly to senior management on activities and status.

Qualifications

• 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 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: minimum 25% domestic and international travel.
• Hybrid remote and in-office work location.

Education

• Bachelor's degree in engineering required; Master’s/MBA/PhD preferred.

Skills

• Agile decision making, project engineering, regulatory compliance, QA, stakeholder engagement.
• Leadership, collaboration, inclusive leadership, developing others.
• Science, technology, engineering and math (STEM) application.