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
Responsibilities
- Subject Matter Expert in the following areas: analytical, bioanalytical, microbiological and/or environmental samples testing, depending on the technical role assigned.
- Independent in terms of planning, coordination and scheduling of activities.
- Ability to work effectively internally and externally in terms of coordinating and initiating purchase of materials for QC usage which includes consumables, reagents, test media, test cultures, small equipment, glassware, plasticware etc.
- Effective coordination of logistics aspects of samples and QC materials.
- Ensure all laboratory operations including test execution, review and data documentation are performed according to cGMP procedures.
- Participate in writing and reviewing of SOP. Take on SOP ownership and ensure that the SOPs developed are in compliant with regulatory standards/policies.
- Demonstrate capabilities in executing equipment qualification and method verification/validation activities independently.
- 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.
- To support supervisor/manager in reviewing protocols/reports/SOPs and other documents assigned by the supervisor/manager.
- 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.
- To conduct training as subject matter expert in the test methods, systems and equipment assigned.
- Supports improvement initiatives, programs and projects driven from the Quality Management System
- Support as subject matter expert during internal and external audits/inspections.
- Escalates quality and compliance risks to QC Management and QA.
Requirements
- Degree/Diploma in Science, Pharmacy, Pharmaceutical Science, Engineering or equivalent
- Specialist Level – Preferably with more than 2 years of relevant work experience in Quality Control in the pharmaceutical/biotechnology/medical device industry
- Senior Specialist Level – Preferably with more than 4 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