Senior Executive, Quality Control (Raw Material Testing)

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 Executive, Quality Control (Raw Material Testing)

Reports To
Associate Director, Quality Control

Responsibilities

  • Responsible for routine testing which includes analytical, bioanalytical, microbiological and/or environmental samples testing.
  • Ensure incoming materials are sampled and distributed in accordance to approved SOP.
  • 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, plasticware 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.
  • Escalate quality and compliance risks to QC Management and QA.
  • Any other responsibilities assigned by the QC Management

Requirements

  • 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
  • Able to work in a fast-paced environment