Senior Specialist/ Specialist, Quality Control (Drug Product Sterile Filling)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of 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 will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position
Senior Specialist/ Specialist, Quality Control (Drug Product Sterile Filling)

Responsibilities

  • Responsible for routine testing which includes analytical, bioanalytical, microbiological and/or environmental samples testing
  • Coordinating and scheduling of testing activities
  • Coordinate and initiate purchase of materials for QC usage which includes consumables, reagents, test media, test cultures, small equipment, glassware, plastic ware etc.
  • Ensure all laboratory operations including test execution, review and data documentation are performed according to cGMP procedures
  • Participate in creating SOP, reviewing SOP, equipment qualification and method verification/validation activities
  • Coordinate/Perform calibration and preventive maintenance of laboratory equipment
  • Initiate quality document such as out of specification investigation, deviation record, change control etc if necessary
  • Support in the timely resolution of issues, including discrepancies, investigations and implementation of CAPAs
  • Support supervisor/manager in reviewing protocols/reports/SOPs and other documents assigned by the supervisor/manager
  • Participate in equipment qualification, method validation/method verification activities which include protocols preparation and review
  • Perform trend analysis of test data that are essential for monitoring purpose
  • Conduct training as subject matter expert in the test methods, systems and equipment assigned
  • Support improvement initiatives, programs and projects driven from the Quality Management System
  • Support as subject matter expert during internal and external audits/inspections

Requirements

  • Degree/Degree, Diploma in Science, Pharmacy, Pharmaceutical Science, Engineering or equivalent with preferably more than 2 years of relevant work experience in Quality Control in the pharmaceutical/biotechnology/medical device industry
  • Working knowledge in regulatory requirements pertaining to the relevant technical role
  • Good team player with excellent planning, coordination and interpersonal skills
  • Proficient in technical writing and presentation