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.
Senior Expert, Quality Control (Method Validation)
Associate Director, Quality Control
- Perform method qualification/validation activities, support QC testing, critical materials qualification, equipment qualification as per agreed lead-time/milestones
- Oversee technical projects related to his/her areas of expertise which may include biological/analytical testing management, method development, method qualification, method validation, method suitability, method transfer, equipment qualification etc.
- Develop documents such as policies, procedures, SOPs, protocols, reports, technical documents related to his/her areas of expertise.
- Technical lead or key member of specific technical project as assigned by the QC management.
- Initiates/Reviews/approves procedures, documents, records, deviations, investigations, corrective action/preventive actions, changes controls and gaps assessment associated with the QC area(s) assigned
- Manages and works closely with QC analysts to plan, organise and execute the validation & qualification activities per approved protocols and ensures resources are used efficiently and effectively for timely delivery of results meeting project timelines
- Supports the implementation of validated in-house assays and the establishment of associated workflow, standard operating procedures
- Provides necessary technical expertise to support investigations of non-compliance, deviations and out-of-specifications
- Participates in technical transfer, assay development & qualification projects and response to regulatory queries pertaining to QC testing
- Establishes program(s) and procedures to monitor the performance and manage the life cycle of in-house assays ensuring they are in a state-of-control
- Establishes trend analysis of test results for the bio-analytical assays, stability of drug substances & products supporting product quality review exercise
- Provide training/coaching to QC personnel pertaining to the assigned technical role.
- Supports improvement initiatives, programs and projects driven from the Quality Management System
- Support as subject matter expert during internal and external audits/inspections.
- Degree in Science, Pharmacy, Pharmaceutical Science, Engineering or equivalent
- With preferably more than 4 years of relevant work experience in Quality Control in the pharmaceutical/biotechnology/medical device industry
- Experience in method development, method validation/qualification specifically in the following areas: Cell-based and analytical assays (e.g. HPLC, PCR, ELISA, Flow Cytometry)
- Knowledge and experience in statistical analysis tools e.g. ANOVA, Design of Experiment
- At least 2 years of experience as project lead or team lead
- Team player with excellent coordination and planning skills.
- Attention to details and able to undertake tasks independently and proactively
- Proficient in both written and verbal presentation and communication