Executive, Quality Control (Microbiology)

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 (Microbiology)

Reports To
Manager, Quality Control

Responsibilities

  • Responsible for routine testing which includes sterility testing, endotoxin testing, microbial identification, mycoplasma testing and other microbiological test methods.
  • Coordination and scheduling of testing activities.
  • Ensure all laboratory operations including test execution, review and data documentation follow cGMP procedures.
  • Ensure timely completion of testing and reporting of test results in support of manufacturing operations.
  • 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.
  • Participate in creating SOP, reviewing SOP, equipment qualification and method verification/validation activities.
  • Coordinate/Perform calibration and preventive maintenance of laboratory equipment
  • Work together with the QC Staff in the timely resolution of issues, including discrepancies, investigations and implementation of CAPAs.
  • 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.
  • Participate in method validation/method verification activities which include protocols preparation and review.
  • Provides necessary technical expertise to support investigations of non-compliances, deviations and out-of-specifications
  • Establishes trend analysis of test data that are essential for monitoring purpose.
  • To conduct training as subject matter expert in the test methods, systems and equipment assigned.
  • To support other QC/Site operation activities when required.

Requirements

  • Bachelor’s degree in Life Science/Biochemistry/Biotechnology/Microbiology or equivalent with at least 1-2 years of working experience in technical position in biopharmaceutical industry and cGMP environment
  • Able to work with people from different background and levels
  • Diploma in Life Science/Biochemistry/Biotechnology/Microbiology or equivalent with at least 3-5 years of working experience in technical position in biopharmaceutical industry and cGMP environment
  • Hands-on experience in the following areas are preferred:
    • Quality Management System and Current Good Manufacturing Practice
    • Cleanroom Monitoring
    • Microbiological Testing e.g. Sterility, Bacterial endotoxin
  • Being open-minded, resourceful and able to think strategically when dealing with challenges and solving problems
  • A good team player with excellent planning, coordination and inter-person skills
  • 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 and manage multiple projects