Innovative Medicine Project Delivery Synthetics Technical Lead

Role Summary

Innovative Medicine Project Delivery Synthetics Technical Lead, a technical leadership role within Engineering & Property Services, overseeing facility design, standards, and project delivery for Small Molecule Synthetics API and Drug Product facilities across multiple sites and locations.

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 Synthetics capital projects.
• Oversee the design and creation of Facility and Equipment processes and standards for safe, compliant, and reliable startup from project to operations.
• Develop new engineering standards for facility design of Small Molecule Synthetics.
• Provide expert engineering technical support for facility business needs, design, construction, commissioning, and process validation for greenfield and brownfield facilities.
• Nurture future talent by mentoring internal and external engineers.
• Collaborate with the Global Engineering Technology team to align 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 growth and efficiency.
• Report regularly to senior management on activities and status.

Interfaces

• J&J Engineering & Property Services (E&PS).
• E&PS Project leadership (Project Director, E&PS Director).
• J&J Quality Assurance.
• J&J Global Engineering and Technology (GET).

Requirements

• Expert knowledge in Small Molecule Synthetics API and Drug Product processes, including materials handling, synthesis, purification, drying, milling, packaging, cleaning, waste handling, and gowning.
• Experience with OSD Batch Manufacturing, OSD Continuous Manufacturing, wet granulation, dispensing, sizing, blending, compression, encapsulation, lubrication, screening, coating, drying, packaging, and cleaning processes.
• Bachelor’s in engineering (Master’s/MBA/PhD preferred).
• Minimum 12 years of manufacturing, project engineering, supply chain, and capital project execution 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 and communicate with poise in a high-profile environment.
• Fluent in written and spoken English.
• Minimum 25% domestic and international travel.
• Hybrid remote and in-office primary work location.