Senior Specialist, Quality Control (Materials Testing)

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

Senior Specialist, Quality Control

Reports to

Associate Director, Quality Control

Job Description

  • Works with all relevant GMP functions to establish qualification and monitoring program on control & testing of ancillary materials (AM) used in manufacturing
  • Be responsible for establishment and implementation of AM control & testing associated workflow, standard operating procedures, specifications and sampling in accordance with cGMP requirements and applicable regulatory guidelines
  • Oversees the operations of AM control & testing as per established procedures
  • Works closely with materials supply teams ensuring coordinated and effective control over AM to meet operational needs
  • Acts as subject matter expert in AM testing area in handling and supporting QMS associated activities including but not limited to audit, investigation, change control, deviation, CAPA, risk assessment, etc
  • Leads a small team and provides training, coaching to junior team members
  • Serves as the point-of-contact for coordination and communication of AM control & testing related matters with internal stakeholders and external contract laboratories
  • Attends and / or organizes inter-departmental or cross-departmental working group meetings and discussions relating to AM control and testing
  • Performs trending on non-conformances to ensure the validity of sampling plans meeting regulatory requirements
  • Be Involved in budgetary projection and service & quality agreements relating to AM testing

Requirements

  • Bachelor Degreer in Biology/Life Science/Biochemistry/Biotechnology/Bioengineering /Chemistry or equivalent with at least 5 years of working experience in materials control & testing in biopharmaceutical industry and cGMP environment
  • Hands-on experience, strong knowledge and deep understanding in the following areas are preferred:
    • QMS and cGMP
    • USFDA and other regulatory requirements and guidelines for materials control
    • US Pharmacopeia for materials testing
    • Sampling plan and Skip-lot concepts
    • Sampling related statistical analysis
    • Risk assessment (for example, FMEA)
    • SAP or ERP, TrackWise and LIMS computer systems
  • Prior experiences in materials control & testing in Cell Therapy or Biologics, being in a leadership role for at least 2 years with good people management skills are desirable
  • 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 take on the assigned tasks timely and play proactive role at work
  • Proficient in technical writing and presentation
  • Able to work in a fast-paced environment and manage multiple projects
  • Able to travel with short notice if required