Senior Expert, Quality Control (ASAT)

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 Expert, Quality Control (ASAT)

Responsibilities

  • As part of the QC ASAT (Analytical Science and Technology) team to lead/execute technical projects related to his/her areas of expertise which may include raw materials test methods implementation, method optimization, method qualification, method validation, method suitability, method transfer, QC equipment qualification and other ASAT related projects.
  • Develop documents such as policies, procedures, SOPs, protocols, reports, technical documents related to his/her areas of expertise.
  • Technical lead or key member of specific technical project as assigned by the QC management.
  • Ensure timely completion of assigned activities which include testing, method qualification/validation, equipment qualification or computer systems validation as per agreed lead-time/milestones.
  • Initiates/Reviews/approves procedures, documents, records, deviations, investigations, corrective action/preventive actions, changes controls and gaps assessment associated with the QC area(s) assigned
  • Participate/lead periodic review of equipment, systems or methods, depending on the technical role.
  • Perform trend reviews of methods, quality data, systems, as required.
  • Provide training/coaching to QC personnel pertaining to the assigned technical role.
  • Key subject matter expert in assigned QC system(s), equipment, process(es).
  • Supports improvement initiatives, programs and projects driven from the Quality Management System
  • Support as subject matter expert during internal and external audits/inspections.
  • Serve as application administrator for role assigned to non-testing function such as QC systems.
  • Escalates quality and compliance risks to QC Management and QA.
  • Any other responsibilities assigned by the QC Management

Requirements

  • Master’s degree/Degree in Life Science, Pharmaceutical Science, Chemical Engineering or equivalent with preferably more than 3 years of relevant work experience in assay development/qualification/validation in the pharmaceutical/biotechnology/medical device industry
  • Working knowledge in regulatory requirements pertaining to analytical method life cycle management is preferred
  • Working experiences with cell-based assay/flow cytometry/PCR/ELISA are preferred
  • A team player with good coordinating & organizing skills, able to work independently and/or within team(s) with minimum guidance
  • Good communicator, able to communicate with clarity and openly
  • Able to work in a fast-paced environment, multi-task and undertake tasks timely & proactively