Life Sciences Smart Manufacturing Strategy & Innovation Manager

About This Role

This role drives the digital transformation of manufacturing processes within the life sciences sector, focusing on smart manufacturing, capital projects, technical transfers, and CMC process development. It requires leadership in implementing advanced digital solutions and ensuring operational excellence for biopharmaceutical clients.

Responsibilities

• Oversee end-to-end delivery of complex GMP-regulated capital programs from concept to operational handoff, ensuring optimized timelines, resources, and risk mitigation.
• Partner with global and cross-functional teams to standardize and scale manufacturing capabilities, ensuring compliant, scalable, and repeatable processes for new product introductions and technical transfers.
• Architect and implement digital modernization roadmaps, leveraging platforms for digitized data collection, predictive analytics, and real-time operational insights.
• Deploy AI-driven analytics and self-service reporting tools to enhance manufacturing performance and accelerate value realization for biotech organizations.
• Act as a liaison between operational teams and executive leadership, translating technical and regulatory requirements into actionable projects and measurable business value.
• Own governance frameworks to align KPIs/OKRs, track ROI, and standardize engineering/validation practices across multiple sites, leading customer-focused initiatives in digital training and continuous improvement.

Requirements

• 9+ years' experience in biopharmaceutical manufacturing, capital project management, or digital operations leadership
• Experience with new capital project delivery, technical transfer, and CMC process development for regulated life sciences environments
• Deployment of smart manufacturing/IIoT applications (AWS, OSI PI, MES, MQTT, Cognite, HighByte, etc.)
• Experience leading programs for global enterprises and/or major pharma clients
• Expert in standard engineering and validation practices (URS, FAT, SAT, IQ/OQ/PQ)
• Must be legally authorized to work in the United States now and in the future

Qualifications

• A Bachelor's Degree in Industrial or Mechanical Engineering, Computer Science/Computer Engineering, Electrical Engineering or equivalent
• 9+ years' experience in biopharmaceutical manufacturing, capital project management, or digital operations leadership

Nice to Have

• Track record of partnering with Quality, Validation, Automation, and Operations functions to deliver compliant, modernized manufacturing capabilities
• MBA or advanced degree in engineering or life sciences
• Consulting experience or experience in a customer-facing product leader role
• Delivery of multi-phase, multi-site digital transformation/modernization initiatives in biopharma or adjacent life sciences sectors

Skills

* Required skills