Senior Analyst/ Senior Expert, Information Technology (CSV)

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
Senior Analyst/ Senior Expert, Information Technology (CSV)

Responsibilities

  • Act as key point of technical contact for business for the responsible systems and translate business requirements into functional requirements specifications, workflows and identifies cross-functional dependencies to drive continuous systems enhancements and improvements.
  • Collaborate and provide consultation to functional stakeholders related to business computing requirements and provide appropriate IT solutions.
  • Research and provide best practice recommendations with a focus on end-to-end system capabilities and using technologies to drive productivity of the business processes (inclusive of defining and delivering the interfaces and Data Analytics platforms of the applications in the portfolio)
  • Lead or support GxP projects through all project stages (design, funding , installation, demonstration, validation and optimization) inclusive of managing system projects plans, deliverables and schedules, cost estimates and change plans to ensure successful system deployment and upgrades with established goals.
  • Ensure GxP systems are always being maintained in a controlled state and in adherence to SDLC, Data Integrity and GxP regulations and practices
  • Perform Computer Systems Validation (CSV) for Enterprise System
  • Maintain validated state of the Enterprise Systems, include LIMS, SAP, QMS, CDAS, etc
  • Prepare and administer qualification documentation such as validation plan and protocols for Software Applications
  • Responsible for authoring and review of test protocols, oversee the execution of test protocols and review the execution data and prepare summary reports.
  • Responsible for projects which involve software upgrade, data migration, server and infrastructure qualification.
  • Responsible for GxP Systems related administration and operation support activities for the responsible systems to effectively support manufacturing operations and regulatory compliance (not limited to system configuration, user access administration, performance monitoring, periodic review and downtime management)
  • Collaborate with the functional stakeholders on the Disaster Recovery/Business Continuity Plan for the GxP systems.
  • 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 LIMS, Empower and other Laboratory Systems
  • Coordination of incidents, services and change requests with Tessa Business Process Owners (BPO) and include the following
  • Lead deployment of new GxP Applications

Requirements

  • Bachelor Degree in Computer Science, Engineering or other relevant disciplines
  • Minimum 3 years of CSV/IT experience. 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 would be added advantage
  • Knowledgeable about FDA\EMA compliance requirements
  • 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 mange 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