Principal/Senior Expert, Information Technology (Infrastructure)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

Job Position
Principal/Senior Expert, Information Technology (Infrastructure)

Responsibilities

  • Developing strong working relationships and collaborate with colleagues throughout the company to ensure the IT GxP delivers infrastructure solutions are meeting the user requirements, regulatory compliance and aligning with industry best practice.
  • Providing L3 support and advisory on best industrial practices for storage / OS / Virtualization / Backup inclusive of applying ITIL, SCRUM and SLA concepts as good practices on the ground and assessing the IT GxP infrastructure and operations and advising appropriate infrastructure model for each GxP computerized system e.g. on premise or cloud application hosting.
  • Providing L2 / L1 infrastructure services support to GxP systems to ensuring SAP, LIMS, Empower, EMS and instrument-based hardware (servers, PCs, label printers and scanners) are deployed and maintained for the operations.
  • Managing and supporting Acronis backup inclusive of deployment of new backup agents to the GxP computerized systems and monitoring and resolving backup issues and performing restore as per requests.
  • Managing and supporting OKTA SSO inclusive of setting up OKTA to the new GxP computerized systems and troubleshooting and resolving users OKTA authentication issues.
  • Provisioning the new Virtual Machines (VMs) and Instrument-based PCs for the applications and monitoring the hardware health of the VMs and PCs.
  • Provisioning the new NAS folders and working with IT helpdesk for the setting up of the security groups.
  • Working with IT GxP team members and business SMEs (e.g. QC, Manufacturing and Engineering, Supply Chain SMEs) for the infrastructure requirement of the applications and proposing the technical solutions.
  • Working with IT GxP team members and business SMEs (e.g. QCS, Manufacturing and Engineering, Supply Chain SMEs) and QA for the changes, incidents and improvement plans for the GxP infrastructure components.
  • Working with IT Corporate to troubleshoot network issues for the GxP computerized systems.
  • Working with procurement and vendors for the procurement of IT GxP infrastructure components.
  • Lead & Support Disaster Recovery (DR) exercises for the GxP computerized systems and working with the hardware and software vendors during the disasters of the computerized systems to recover the systems to its operational states.
  • Developing standard operating procedures (SOP) and validation documents for the IT GxP infrastructure and ensuring they are meeting the operational requirements and regulatory compliances.
  • Leveraging own technical knowledge and experiences to render assistance to improving IT GxP infrastructure compliance and business operation efficiency.
  • Accountable for prioritization, escalation and timely resolution systems issues, elevate them to external vendors as appropriate (Includes systems root cause analysis, development of solution proposals, and establishing use cases from business through Digital means).
  • Technical SME for regulatory audits including liaison with QA compliance teams or business process owners for any IT audit requests (including infrastructure requests of the supported systems).
  • Ensure the IT systems and processes deployed for GxP operations comply to applicable current GxP regulations, as well as established IT policies and procedures.
  • Develop and maintain IT procedures and controls to support GxP activities and operations.
  • Review, provide inputs and/or support the execution of associated procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments.
  • Manage IT vendors involved in GxP activities, and ensure they are trained and comply to applicable current GxP and regulations, as applicable.
  • Perform other duties as assigned by the organization.
  • Day to Day Support Acronis and PC Based Applications as Systems Administrators, Server Performance Monitoring for all GxP applications
  • Coordination of incidents, services and change requests with Tessa Business Process Owners (BPO) for IT related systems
  • Other IT and CSV related support, Decommissioning activities, whenever necessary

Requirements

  • Bachelor’s Degree in Computer Science, Engineering or other relevant disciplines
  • Minimum 5 years of Infrastructure related experience, SQL Server, Azure AD, Backup & recovery, DRP. Working experience in either manufacturing or supply environment in the biotechnology and\or pharmaceutical industry would be at added advantage.
  • Working Experience with project management or system support experience related to SAP IBM Cloud Hosting, would be added advantage
  • Demonstrated business acumen and experience in managing projects of complexity.
  • Strong analytical and problem-solving skills for transforming defined business needs into system requirements.
  • Ability to effectively coach and mentor project team members or users
  • Strong vendor Management experience
  • Strong interpersonal and influential skills
  • Ability to multitask and manage multiple projects in a cross-functional environment
  • Self-motivated and able to work in a high pace environment
  • Effective communication skills. Strong written and verbal English proficiency
  • Knowledgeable about FDA\EMA compliance requirements