Associate Director, Hypercell, Development Strategy Lead

Role Summary

The Hypercell team is driving transformation across Cell Therapy by streamlining supporting processes through digital, automation, and AI-enabled solutions. The Development Strategy Lead will work with the GO-Solo and Brickyard teams to ensure a seamless transition from development to commercialization, focusing on Hypercell capability. This role will help ensure the GO-Solo and Brickyard processes integrate into Hypercell's mission to reduce complexity, eliminate duplication, and improve cost-effectiveness across the network. Locations: Devens, MA; Seattle, WA; Summit West, NJ.

Responsibilities

• Core team member for Brickyard & GO-Solo teams focused on Hypercell considerations across program development
• Develop a data pipeline for Brickyard & GO-Solo incorporating learnings from current state programs and data availability
• Develop a holistic strategy for development programs to transition into commercial with integrated data availability for improved process understanding
• Collaborate with the Cell Therapy Automation team to deliver a cohesive strategy for unified data model integration to enable use in Hypercell developed automated systems - validation protocols/reports, investigations, real-time modeling/response, and potentially development reports
• Work closely with Business Insights & Technology (BI&T) colleagues to build unified data models and enable automated report writing using available source data
• Support the development and deployment of AI-facing tools that deliver innovative and efficient solutions for end users across the business
• Partner with digital and automation leads to integrate smart technologies into supporting processes
• Mentor junior engineers and contribute to a culture of innovation, technical excellence, and continuous improvement

Qualifications

• Required: Bachelor's, Master's, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• Required: 8-10 years of experience in cell therapy or biologics manufacturing, with hands-on expertise in PPQ, deviations, change control, statistical monitoring, and APQRs.
• Required: Strong understanding of GMP regulations and regulatory expectations for advanced therapies.
• Required: Experience with process development approaches and execution.
• Required: Proficiency in data analysis tools and statistical software (e.g., JMP, Minitab, Python).
• Required: Excellent communication, project management, and problem-solving skills.
• Preferred: Experience with digital manufacturing platforms, automation technologies, and AI-driven process optimization.
• Preferred: Familiarity with tech transfer across global sites and external partners.
• Preferred: Demonstrated ability to lead cross-functional teams and drive strategic initiatives.

Skills

• Data analysis tools and statistical software (JMP, Minitab, Python)
• Strong communication, collaboration, and problem-solving abilities
• Leadership and mentoring capabilities
• Analytical thinking and adaptability in a dynamic, matrixed environment