IM PD Bio-Therapeutics Technical Lead

Role Summary

Innovative Medicine Project Delivery ATMP Technical Lead responsible for expert engineering leadership in facility design, construction, commissioning, and process validation for Drug Substance and Drug Product facilities within IM Bio-Therapeutics. Defines and deploys standard facility and equipment design across IM capital projects and ensures seamless transition from project to operations.

Responsibilities

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

Qualifications

• Education: Bachelor's in engineering required; Master's/MBA/PhD preferred.
• 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 experience.
• Experience managing large capital projects over $250 million.
• Ability to balance multiple priorities and operate with poise in a high-profile environment.
• Fluent in written and spoken English.
• Travel: 25% domestic and international.
• Hybrid remote and in-office work location.

Skills

• Agile Decision Making
• Budget Management
• Collaborating
• Regulatory Compliance
• Quality Assurance
• Stakeholder Engagement
• Leadership and Developing Others
• LEaN and Project Management

Education

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

Additional Requirements

• Minimum 25% domestic and international travel.
• Hybrid work arrangement.