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.
Associate Director/ Senior Manager, Validation Lead (Drug Product Sterile Filling)
As a Validation Lead (Drug Product Sterile Filling), you will work in an environment where you can oversee the new Fill and Finish facility validation aspects at different phases.
- Responsible for developing the validation strategy including:
- Design/Preconstruction oversight of URS, VMP and Design Qualification requirements
- Construction phase oversight of commissioning, testing and control document requirements
- Qualification phase oversight for execution of Filling and Finishing equipment, Visual Inspection equipment and facility qualification activities, including temperature-controlled objects, HVAC, and cleanroom qualification
- PQ and PPQ of a fill and finish program
- Validation lifecycle maintenance along with system owners
- Responsible for recruiting, developing, mentoring, and evaluating a small team to ensure effective operations of the Validation group, particularly external contractors.
- Conducts performance reviews and drives goals setting and development activities for the team.
- Drive accountability for the timely execution of validation and qualification activities.
- Work with Quality Validation group to ensure and align on the compliance of the fill finish validation requirements
- Maintain a state of validation once the lifecycle of the system has been fully qualified.
- Maintain all qualification/validation documents with the QMS.
- Maintain strong working relationships with inter-department stakeholders as well as external contractors
- Establish qualification and validation strategies, including procedures and accountability metrics for the team.
- Prioritize portfolio of activities as well as understand/ communicate the risks associated with the validation strategy.
- Communicate effectively across functions. Align goals and priorities for the timely execution of validation activities. Engage in both technical and tactical discussions to ensure stakeholder alignment.
- Participate in organizational activities including due-diligence meetings, organizational development and team building activities to further the culture of Tessa Therapeutics.
- Master’s degree/Degree in Engineering/Biotechnology or any related field with at least 10 years of relevant working experience in cGMP environment for Biologics/Vaccines Fill and Finish facility.
- Experience with sterile fill, process validation of filling equipment and visual inspection is desirable
- Prior experience in ASTM E2500, Equipment Qualification, Computer systems validation, Aseptic Process Simulation; particularly in a commercial manufacturing setting.
- Deep understanding of cGMP validation requirements and trends
- Experience in fronting regulatory audits, particularly Pre-approval Inspections (PAIs)
- Ability to demonstrate both technical leadership and team leadership
- Able to think outside the box to develop and execute validation strategies for cell therapy applications.
- Flexible and proactive in working on solving issues and problems
- Ability to drive decision making within a multi-disciplinary, multi-region matrix team
- Able to communicate with impact, ensuring alignment and negotiating positive outcomes in his/her area of work.
- Comply to Tess safety practices and standard operating procedures
- Proficient in statistical analysis and technical writing