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.
Manager/Lead, Quality Control (Bioanalytical)
- Responsible for overseeing the Quality Control Bioanalytical (bioassay and analytical testing) Team which includes raw materials, in-process and finished product testing.
- Owns QC related polices and procedure of the assigned QC processes which include product testing, materials testing, method qualification/validation, lab investigations, stability testing, LIMS, lab equipment qualification and/or calibration.
- Ensure timely completion of assigned activities which include testing, method qualification/validation, equipment qualification or computer systems validation as per agreed lead-time/milestones.
- Initiates/Reviews/approves procedures, documents, records, deviations, investigations, corrective action/preventive actions, changes controls and risk assessments.
- Ensure QC personnel are qualified and trained to perform assigned tasks
- Support product/materials testing, methods qualification/validation activities, equipment qualification activities or other QC related activities as an executor, reviewer and/or approver.
- Ensure products are tested and assessed per applicable current GxP and regulations.
- Serve as key subject matter expert in assigned QC system(s), equipment, process(es).
- Ensures that facilities, equipment, materials, processes and procedures that are applicable to QC comply to applicable, current GxP regulations
- Manage performance and development of direct reports to ensure achievement of organizational goals
- Supports improvement initiatives, programs and projects driven from the Quality Management System
- Degree in Chemistry, Microbiology, Pharmacy, Pharmaceutical Science, Biotechnology or equivalent
- Preferably more than 6 years of relevant work experience in Quality Control (and in which more than 3 years are in the supervisory role) in the pharmaceutical processing/biotechnology manufacturing/medical device manufacturing.
- Good interpersonal and leadership skills
- Advanced knowledge in regulatory requirements e.g. FDA, EMA, ICH requirements
- Growth mindset, able to think strategically when dealing with challenges and solving problems
- A team player with excellent coordinating & organizing skills, able to work independently and / or within team(s)
- Effective oral and written communication skills