The Lead – IT Site Shared Services & Lab Systems for Cell Therapy manages the successful operation of manufacturing and business functions as well as the successful implementation of benchtop systems with the QC laboratories and manufacturing shop floor benchtop systems through interaction with internal team members, peer and higher level customers as well as external service providers.

• Own and manage the IT shared landscape across the Cell Therapy site IT systems like IT Architecture and IT Infrastructure including Network, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.
• Own the IT Life Cycle Management (LCM) program as well as the roadmap for all the above listed IT Infrastructure.
• Be the CTF IT Cybersecurity Point Of Contact (POC) and own the system patching effort for various local IT systems.
• Provide Point of Contact (POC) services to benchtop business system owners for IT services.
• Monitor, track and reduce ServiceNow tickets related to IT Infrastructure.
• Manage spares and inventory for IT Infrastructure.
• Manage support Periodic reviews of Benchtop systems (as required).
• Own the Disaster Recovery of local computerized systems and be the main POC during P1 and P2 ServiceNow tickets.
• Accountable for uninterrupted 24/7 operation of manufacturing systems for CAR-T manufacturing.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Ability to effectively communicate with both technical and non-technical team members.
• Strong interpersonal skills, especially regarding:
  • Teamwork and collaboration
  • Client focus
  • Verbal and written communication
• Knowledge of Cell Therapy Facility (CTF) IT Architecture and IT Infrastructure including Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall Rules, Domains, etc.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
• Knowledge of Cybersecurity, patching and IT Life Cycle Management (LCM).
• Understanding of computer system validation.

Education and Experience:

• Bachelor’s degree in an engineering or MIS discipline
• Must have experience with Cybersecurity, patching, supporting the implementation of Benchtop systems used in QC laboratories and Manufacturing shop floor and IT Life Cycle Management (LCM) in a bio-tech manufacturing environment.
• Must have 10+ years of hands-on experience in a biotech manufacturing and supply chain environment
• Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
• Sound understanding of a Cell Therapy manufacturing facility IT Architecture and IT Infrastructure including Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.