Associate Director, Hypercell, Process Engineer

Role Summary

Associate Director, Hypercell, Process Engineer role leading process engineering for Hypercell cell therapy operations, focusing on process lifecycle management, automation, and AI-enabled solutions to enable scalable, compliant, and efficient operations. The role aims to reduce complexity, eliminate duplication, and improve cost-effectiveness across the network by partnering with cross-functional teams and mentoring engineers.

Responsibilities

• Develop tools for automated processing of
  • Process Performance Qualification (PPQ) protocols/reports
  • Continued Process Validation (CPV) reports, Annual Product Quality Reports (APQRs), summarizing process performance and improvement opportunities
  • Statistical process monitoring improvements
• Collaborate with cross-functional teams including MS&T, QA, Regulatory, and Manufacturing to support tech transfer, validation, and regulatory submissions.
• Work closely with Business Insights & Technology (BI&T) colleagues to build data hierarchies 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.

Skills

• Strong understanding of GMP regulations and regulatory expectations for advanced therapies.
• Experience with closed-system processing, aseptic techniques, and single-use technologies.
• Proficiency in data analysis tools and statistical software (e.g., JMP, Minitab, Python).
• Excellent communication, project management, and problem-solving skills.
• Experience with digital manufacturing platforms, automation technologies, and AI-driven process optimization.
• Familiarity with tech transfer across global sites and external partners.
• Demonstrated ability to lead cross-functional teams and drive strategic initiatives.

Education

• Bachelor's, Master's, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.