Innovative Medicine Project Delivery Synthetics Technical Lead

About This Role

This role involves providing expert engineering technical support and guidance for strategic greenfield and brownfield Small Molecule Synthetics API and Drug Product facilities. The Synthetics Technical Lead defines and deploys a vision and strategy for standard Facility and Equipment design for all Innovative Medicine Synthetics capital projects. This position focuses on ensuring the safe, compliant, and reliable transition from project build to start-up phase.

Responsibilities

• Keep abreast of all current industry and regulatory standards and trends (483s, audit reports, etc.) to ensure IM Synthetics manufacturing plants are designed, built, and commissioned to leading edge industry standards.
• Define and deploy a vision and strategy for a standard Facility and Equipment design for all IM Synthetics capital projects.
• Oversee the design and creation of all necessary Facility and Equipment processes and standards to ensure the safe, compliant, and reliable transition from project build phase to start-up phase.
• Develop new engineering standards for facility design for Small Molecule Synthetics.
• Provide expert engineering technical support and guidance in facility business need, design, construction, commissioning, and process validation for greenfield and brownfield Small Molecule Synthetics API and Drug Product facilities.
• Nurture future talent by mentoring both internal and external engineers.
• Collaborate with the Global Engineering Technology (GET) team head to ensure alignment with technology standards, project execution, and engineering specifications for manufacturing technology.
• Ensure compliance with policies, procedures, government regulations, and customer specifications.
• Proactively research and implement new standards to drive business growth and efficiency.
• Report out to senior management regularly on activities and status.

Requirements

• Bachelor's engineering degree
• 12+ years of manufacturing, project engineering, supply chain and capital project execution experience in the Small Molecule Synthetics API and Drug Product Industry
• Hands on experience designing, constructing, commissioning or qualifying manufacturing process equipment
• Strong Small Molecule Synthetics API and Drug Product process engineering expertise
• Large capital project management experience over $200 million
• Ability to balance multiple priorities, communicate and operate with poise and integrity
• Fluent in written and spoken English

Qualifications

• A minimum of a Bachelor's engineering degree is required, Master's/MBA/PhD is preferred.
• A minimum of 12 years of manufacturing, project engineering, supply chain and capital project execution in the Small Molecule Synthetics API and Drug Product Industry is required.

Nice to Have

• Master's/MBA/PhD

Benefits