Manager / Senior Specialist, Quality Control(Method Validation)

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create 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

Manager / Senior Specialist, Quality Control

Reports to

Associate Director, Quality Control

Job Description

  • Responsible for drafting protocols and reports for in-house assays method validation & qualification in accordance with cGMP requirements and applicable regulatory guidelines
  • Works closely with QC analysts to plan, organize and execute the validation & qualification activities as 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
  • Establishes trend analysis of test results on the finished products, stability of drug substances & products supporting product quality review exercise
  • 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
  • Provides necessary technical expertise to support investigations of non-compliances, deviations and out-of-specifications
  • Participates in technical transfer, assay development & qualification projects and response to regulatory queries pertaining to QC testing
  • Attends and / or organizes inter-departmental or cross-departmental working group meetings and discussions relating to technical aspects of QC tests
  • Be involved in technical training for junior team members

Requirements

  • Master/Bachelor Degree in Biology/Life Science/Biochemistry/Biotechnology/Bioengineering or equivalent with at least 5 years of relevant experience in technical position in biopharmaceutical industry and cGMP environment
  • In-depth knowledge and understanding in Cell & Molecular Biology and USFDA & ICH guidelines for method validation are required
  • Hands-on experience in the following areas are preferred:
    • Quality Management System and Current Good Manufacturing Practice
    • US Pharmacopeia test methods for Cell, Gene & Tissue based products
    • QPCR and cell-based assays method validation
    • Statistical process control (SPC) and statistical analysis
    • Risk assessment (for example, FMEA)
    • TrackWise and LIMS computer systems
  • Being in the leadership role for at least 2 years is strongly preferred
  • A 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 and manage multiple projects
  • Able to work with people from different background and levels