Associate Director, Hypercell, Process Engineer

Role Summary

Associate Director, Hypercell, Process Engineer leads process lifecycle management for cell therapy and biologics within the Hypercell program. You will drive scalable, compliant, and efficient operations by leveraging digital, automation, and AI-enabled solutions, reducing complexity and duplication across the network. This role supports cross-functional collaboration and mentorship to advance Hypercell's mission to transform patient outcomes. Shifts Available: Monday - Friday, standard working hours.

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.

Qualifications

• Required: 7-10 years of experience in cell therapy or biologics manufacturing, with hands-on expertise in PPQ, deviations, change control, statistical monitoring, and APQRs.

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.