Senior Expert, Quality Control (Systems)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on cancer treatment through the development of autologous and allogeneic cell therapies for a range of cancers.

Our portfolio of next-generation therapies is derived from two innovative technologies: CD30-Chimeric Antigen Receptors (CD30-CARs) and a specific subset of T cells known as Virus-Specific T Cells (VSTs). We are also developing a novel, allogeneic platform technology that combines the unique properties of CD30-CARs and VSTs. This platform anchors our next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility, expected to be ready in 2021, will substantially enhance in-house production capabilities and ensure that patients can benefit from our cell therapies more rapidly.

Patients are at the heart of what we do. Our mission is to change cancer treatment and give patients a new lease on life. We are looking for team members who have a passion for creating breakthroughs in cancer treatment. We want to work with people who seek to go beyond, and to pioneer new innovations. You can find out more about our company by visiting our website: www.tessatherapeutics.com.

Job Position
Senior Expert, Quality Control (Systems)

Reports To
Senior Manager, Quality Control (Systems)

Responsibilities

  • Key member in the implementation of Laboratory Information Management System (LIMS) for QC.
  • Responsible for the equipment qualification activities in QC to ensure that the milestones for each equipment are being achieved as planned in order to support the site tech transfer activities.
  • Support QC Quality Systems related activities which include Lifecycle management of QC equipment, qualification, maintenance, periodic review, replacement and retirement of equipment, the maintenance of electronic systems/data from local/standalone systems, as well as serving as subject matter expertise for laboratory network and standalone system
  • Perform as the application administrator role within QC.
  • Support the rolling out of data integrity initiatives within QC.  To conduct data integrity training to QC.
  • To be the equipment owner, if necessary, for any commonly used equipment that are not being dedicated to any specific test or operation.
  •  Establish and maintain Quality Control policies or procedures that are essential for the QC Systems operations and control
  • Ensure regulatory and customer inspections readiness; represent area and participate in audits and inspections
  • Review Quality Control procedures pertaining to QC Systems and any other QC operations, if applicable
  • Actively join and support cross-functional project(s), regulatory submission and company-wide initiatives as assigned by supervisor and/or department head
  • To timely alert function management of significant quality, compliance, and safety risks
  • Perform any other ad-hoc duties as assigned by superior

Requirements

  • Bachelor’s degree holder in Biology/ Life Science/ Chemistry/ Biochemistry/ Biotechnology or equivalent
  • At least 4 years of working experience in QC function in pharmaceutical industry or cGMP environment
  • Substantial experiences and knowledges in the following areas are required:
    • Relevant QMS & cGMP
    • Laboratory Information Management System (LIMS)
    • QC Equipment Qualification and Computer System Validation
    • Lab investigation and change management
    • Risk Assessment
    • Lab operations especially in supporting commercial GMP manufacturing
  • Ability to interpret and relate Quality Standards for implementation and review
  • Growth mindset, able to think strategically when dealing with challenges and solving problems
  • A team player with excellent coordinating & organizing skills, able to work independently and/or within team(s)
  • Proficient in both written and verbal presentation and communication, able to communicate with clarity and openly
  • Demonstrate good project management skills, good communication and organization skills
  • Able to work in a fast-paced environment, multi-task and undertake tasks timely & proactively