Senior Expert, Quality Control (Method Validation)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position
Senior Expert, Quality Control (Method Validation)

Reports To
Associate Director, Quality Control

Responsibilities

  • Perform method qualification/validation activities, support QC testing, critical materials qualification, equipment qualification as per agreed lead-time/milestones
  • Oversee technical projects related to his/her areas of expertise which may include biological/analytical testing management, method development, method qualification, method validation, method suitability, method transfer, equipment qualification etc.
  • 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.
  • Initiates/Reviews/approves procedures, documents, records, deviations, investigations, corrective action/preventive actions, changes controls and gaps assessment associated with the QC area(s) assigned
  • Manages and works closely with QC analysts to plan, organise and execute the validation & qualification activities per approved protocols and ensures resources are used efficiently and effectively for timely delivery of results meeting project timelines
  • Supports the implementation of validated in-house assays and the establishment of associated workflow, standard operating procedures
  • Provides necessary technical expertise to support investigations of non-compliance, deviations and out-of-specifications
  • Participates in technical transfer, assay development & qualification projects and response to regulatory queries pertaining to QC testing
  • Establishes program(s) and procedures to monitor the performance and manage the life cycle of in-house assays ensuring they are in a state-of-control
  • Establishes trend analysis of test results for the bio-analytical assays, stability of drug substances & products supporting product quality review exercise
  • Provide training/coaching to QC personnel pertaining to the assigned technical role.
  • Supports improvement initiatives, programs and projects driven from the Quality Management System
  • Support as subject matter expert during internal and external audits/inspections.

Requirements

  • Degree in Science, Pharmacy, Pharmaceutical Science, Engineering or equivalent
  • With preferably more than 4 years of relevant work experience in Quality Control in the pharmaceutical/biotechnology/medical device industry
  • Experience in method development, method validation/qualification specifically in the following areas: Cell-based and analytical assays (e.g. HPLC, PCR, ELISA, Flow Cytometry)
  • Knowledge and experience in statistical analysis tools e.g. ANOVA, Design of Experiment
  • At least 2 years of experience as project lead or team lead
  • Team player with excellent coordination and planning skills.
  • Attention to details and able to undertake tasks independently and proactively
  • Proficient in both written and verbal presentation and communication