Executive, Quality Control (Bioassays)

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies. We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

Job Position
Executive, Quality Control (Bioassays)

Reports To
Senior Manager, Quality Control

Responsibilities

  • Performs cell-based assays on finished product for product release or stability according to internal SOPs and cGMP requirements
  • Ensure timely completion of testing and reporting of test results in support of manufacturing operations.
  • Ensure all laboratory operations including test execution, review and data documentation follow cGMP procedures.
  • Performs lab operations associated QMS activities timely and systematically including but not limited to: documentation, filing, SOP/test protocol draft, risk assessment, investigation for deviation & OOS, change control, CAPA implementation, inspection and other lab-related issues in accordance with current Good Manufacturing Practices (cGMP)
  • Be actively involved in assay qualification and validation, assay transfer activities in accordance with cGMP requirements and applicable regulatory guidelines
  • Ensure all reagents, media, consumables etc required to support testing are available
  • Ensure that data, documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness.
  • Supports QC related activities/projects including but not limited to housekeeping, equipment qualification and maintenance and managing lab supplier, liaise with external vendors
  • Escalate any potential quality issues revealed during QC testing or processing of products especially quality or regulatory issues with the potential to affect product quality or regulatory compliance.
  • To support supervisor/manager in reviewing protocols/reports/SOPs and other documents assigned by the supervisor/manager.

Requirements

  • Bachelor degree holder in Biology/Biochemistry/Biotechnology/Bioengineering or equivalent with at least 2 years of working experience in biopharmaceutical industry and cGMP environment.
  • Hand-on experience and in-depth knowledge in cell culture and/or immunological assays (eg. ELISA) are required
  • Understanding USFDA & ICH guidelines for method qualification and/or validation is advantageous
  • Prior experience in the following areas are preferred:
    • QMS and cGMP
    • Statistical analysis
    • Risk assessment (for example, FMEA)
  • Good team player with excellent planning, coordination and inter-person skills
  • Being open-minded, resourceful and able to think strategically when dealing with challenges and solving problems
  • Attention to details and able to undertake tasks timely and proactively
  • Proficient in technical writing and presentation
  • Able to work in a fast-paced environment
  • Able to work with people from different background and levels