Senior Executive, Quality Control (Raw Materials)

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
Senior Executive, Quality Control (Raw Materials)

Reports To
Senior Expert, Materials Testing

Responsibilities

  • Establish and maintain QC laboratory in full cGMP-compliance
  • Support testing coordination for incoming materials, both internally and externally to ensure the testing can be completed timely to meet production need.
  • Ensure incoming materials sampling is performed in accordance to written sampling plan and in accordance with local/ international regulations
  • Ensure samples are distributed to testing laboratories, both internal or external laboratories in a timely manner
  • Conduct wet chemistry and spectroscopic testing, as required
  • Participate in the validation of internal test methods with external contract lab, as well as in-house method verification of compendial methods, as required. Assist in preparation and reviewing of method qualification protocols and reports
  • Ensure incoming materials have been tested or inspected according to specifications and current approved test method. Perform required data review, compile data and prepare results for review.
  • Assist in the installation of laboratory equipment and qualification of laboratory equipment for intended use in QC laboratory, as required
  • Support non-conformance investigations, corrective and preventative actions and change controls as required
  • Review QC documents to ensure completeness, accuracy, consistency, and clarity
  • Participate in projects for continuous improvement initiatives within QC department
  • Maintain the inventory management and retain sample accurately.
  • Prepare and participate to health authority’s inspections and internal audits in QC Raw Material area

Requirements

  • Master’s degree/ Bachelor’s Degree in Life science, Microbiology, Biotechnology or Chemistry or any related field with at least 5 years of relevant working experience in pharmaceutical GMP-regulated industries.
  • Prior experience in Quality Control Raw Materials lab is preferred
  • Ability to perform analysis of USP and EP pharmacopeia methods
  • Proven ability to effectively collaborate, multitask and work in a fast-paced environment.
  • Must be well-organized and pay close attention-to-detail.
  • Excellent written and oral communication skills.