(Senior) Specialist, Quality Control (Microbiology) (1 year contract)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

Job Position
(Senior) Specialist, Quality Control (Microbiology) (1 year contract)

Responsibilities

  • Responsible for the planning, preparation, execution, and documentation for the TSMO Disinfectant Efficacy Study.
  • Support other routine QC Micro/EM activities as applicable such as housekeeping, plate reading, EM Sampling, material transfer, purchasing, etc.
  • Support coordination and scheduling of testing activities related to DES.
  • Coordinate and initiate purchase of materials for QC usage which includes consumables, reagents, test media, test cultures, small equipment, glassware, plasticware etc.
  • Coordinate shipment of samples and QC materials, as needed.
  • 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 as applicable.
  • 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.
  • Participate in method validation/method verification activities which include protocols preparation and review.
  • Perform trend analysis of test data that are essential for monitoring purpose.
  • Supports improvement initiatives, programs and projects driven from the Quality Management System
  • Escalates quality and compliance risks to QC Management and QA.

Requirements

  • Degree/Degree, Diploma in Science, Microbiology, Biology, 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.
  • Prior experience with SOP or protocol writing and method and equipment validation is a plus.
  • Ability to work effectively under time pressure, multitask and work in a multicultural and cross-functional team.
  • Proficient in basic microbiology techniques and Microsoft office applications.