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

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on cancer treatment through the development of autologous and allogeneic cell therapies for a range of cancers.

Our portfolio of next-generation therapies is derived from two innovative technologies: CD30-Chimeric Antigen Receptors (CD30-CARs) and a specific subset of T cells known as Virus-Specific T Cells (VSTs). We are also developing a novel, allogeneic platform technology that combines the unique properties of CD30-CARs and VSTs. This platform anchors our 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, expected to be ready in 2021, will substantially enhance in-house production capabilities and ensure that patients can benefit from our cell therapies more rapidly.

Patients are at the heart of what we do. Our mission is to change cancer treatment and give patients a new lease on life. We are looking for team members who have a passion for creating breakthroughs in cancer treatment. We want to work with people who seek to go beyond, and to pioneer new innovations. You can find out more about our company by visiting our website: www.tessatherapeutics.com.

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

Reports to
Senior Director, Program Lead (Drug Product Sterile Filling)

Responsibilities

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