Associate Director/ Senior Manager, Validation Lead (Drug Product Sterile Filling)

Company Background

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.

Job Position
Associate Director/ Senior Manager, Validation Lead (Drug Product Sterile Filling)

Job Description

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.
Requirements
  • 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