IM PD Bio-Therapeutics Technical Lead
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Role Summary
Innovative Medicine Project Delivery ATMP Technical Lead. Provide expert engineering leadership for Bio-Therapeutics facility design, construction, commissioning and process validation for Drug Substance and Drug Product facilities. Define and deploy standard Facility and Equipment design strategies, oversee facility and equipment processes and standards, and ensure seamless handover from project to operations across multiple sites/countries. Stay abreast of industry and regulatory standards to ensure facilities meet leading-edge requirements.
Responsibilities
- Keep abreast of current industry and regulatory standards and trends to ensure Bio-Therapeutics manufacturing plants 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 design and creation of Facility and Equipment processes and standards for safe, compliant transition from project to start-up.
- Develop new engineering standards for Bio-Therapeutics facility design.
- Provide expert engineering support in design, construction, commissioning, and process validation for Drug Substance and Drug Product facilities (green/brown field).
- Mentor internal and external engineers to nurture future talent.
- Collaborate with GET team head to align 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.
- Minimum 15 years of manufacturing, project engineering, supply chain and capital project execution in 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.
- Large capital project management experience over $250 million.
- Ability to balance multiple priorities and communicate effectively in a high-profile environment.
- Fluent in English (written and spoken).
- Travel: minimum 25% domestic and international travel.
- Hybrid remote and in-office work location.