Manager, Cell Tracking, Scheduling and Forecasting System

Role Summary

The incumbent is responsible for Ocellos (Trakcel) and Binocs applications that support technical and clinical operations. This role supports patient operations, supply chain, manufacturing and quality teams. The incumbent provides strong experience and understanding of systems that support autologous cell therapy and both GxP and 21CFR part 11 regulations.

Responsibilities

• Responsible for the overall budget and management of projects and functionality that support cell therapy patient operations, including systems Ocellos (Trakcel) and Binocs (scheduler)
• Collaborate with clinical operations, patient operations, supply chain, manufacturing and quality to ensure their business needs are planned for, communicated and met.
• Own cell tracking and scheduling roadmap with alignment across technical operations and clinical operations.
• Ensure Binocs services and workflows are up to date and accurate by owning the configuration and leveraging vendor manages services.
• Establish and nurture vendor relationship with Trakcel. (Status quo on operating model should be challenged and improved)
• Deliver and maintain systems in compliance with GMP and GCP requirements
• Responsible for the interfaces between Cell Tracking and Scheduling systems to other GMP systems to support operations.
• Manage system support programs to support clinical and technical This includes business continuity, off hours and on call support.
• Accountable for system administration
• Maintain system life cycle documents including user requirements, functional technical specifications, and configuration specifications.
• Responsible for executing validation testing including installation, operational and performance qualifications.

Qualifications

• Preferred: BA/BSc in Statistics, Mathematics, Computer Science, Engineering or related fields with 10+ years of experience; or MBA/MSc with 7+ years of experience
• Preferred: Minimum 5 years system experience in biotechnology or pharmaceutical industry, with vendor oversight experience
• Preferred: At least 5 years management experience including management of both budget and a technical team
• Preferred: Autologous cell therapy experience
• Preferred: Experience with GxP and part 11 regulations
• Preferred: Experience with Ocellos (Trakcel) and Binocs
• Preferred: Experience with middleware platforms such as Mulesoft or Dell Boomi

Skills

• Knowledge of full life cycle implementations of Trakcel or Vineti platforms
• Project management for small to medium scale projects
• Strong cross-functional collaboration
• Experience managing a full-service technical support function

Education

• Preferred: BA/BSc in Statistics, Mathematics, Computer Science, Engineering or related fields with 10+ years of experience
• Preferred: MBA or MSc in Statistics, Mathematics, Computer Science, Engineering or related fields with 7+ years of experience