Senior Supervisor / Supervisor, Quality Control (Environmental Monitoring)

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 Supervisor / Supervisor, Quality Control (Environmental Monitoring)

Reports To
Director, Quality

Responsibilities

  • Develops, implements and assesses processes and policies related Environmental Monitoring in compliance with regulatory expectation of aseptic processing.
  • Support of cleanroom qualifications and EM equipment qualifications.
  • Work closely with Manufacturing Team and provide EM support
  • Lead and conduct Environmental Monitoring Risk Assessments.
  • Focus on routine support for site environmental monitoring sampling procedures for facilities, critical utilities, and personnel.
  • Support for classification and validation initiatives that require environmental monitoring support.
  • Support routine environmental monitoring of air, surface, personnel and clean utilities for manufacturing.
  • Supervise employees, tasks and duties related to EM microbiology quality control.
  • Monitors the performance of the quality control staff, ensuring that the EM microbiology quality control department meets organizational objectives.
  • Monitors and evaluates current regulatory requirements, making recommendations for improvements when necessary.
  • Enforces regulatory compliance.
  • Performs investigations related EM excursions, OOS, and adverse trends.
  • Drive Changes and SOP revisions.
  • Initiative and work proactively under minimal supervision.
  • Conducts work in compliance with company SOPs, cGMP, safety and regulatory requirements.
  • Proactive at keeping current with literature and latest technologies.
  • Work well both independently and in a team environment.
  • The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Manager from time to time.

Requirements

  • Degree in life science discipline (Master’s degree preferred) or any related field with at least 5 years of relevant working experience (Environmental Monitoring) in a highly regulated cGMP regulated environment.
  • Prior experience in GMP Biologics and Pharmaceutical industries.
  • Experience in Cell Therapy facilities will be an added advantage but not mandatory.
  • Ability to prioritize work and multitask.
  • Proficient in cGMP and especially current requirements on EM.
  • cGMP audit experience in USFDA, EU and HAS etc.
  • Demonstrated knowledge in Pharmaceutical Microbiology as it relates to Environmental Monitoring, Aseptic Processing, Cleanroom design and behaviour.
  • Experience in clean room qualification, protocol/sampling design and technical investigations.
  • Excellent communication, interpersonal and organizational skills.