Director, QA/QC (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
Director, QA/QC (Drug Product Sterile Filling)

Reports To
Chief Operating Officer

Responsibilities

As a Director, QA/QC, you will be responsible for setting up a fully functional and compliant quality operation to support the clinical and commercial operations at a Fill/Finish site.

  • Provide key leadership, vision, and direction to the Quality team and manage all Quality activities in a compliant way
  • Provide operational expertise and excellence in quality oversight for Fill/Finish Operations.
  • Provide oversight of manufacturing-related quality issues and investigations (e.g. deviations, Out-of-Trend, Out-of-Specification), to ensure their proper and timely completion; including that of the corresponding corrective and preventive actions (CAPA); and monitor effectiveness of implemented CAPAs
  • Coordinate timely and accurately on the delivery of test results required by Manufacturing Operations, Validation and Process Science groups
  • Support process development/transfer and phase appropriate qualification/validation for the Fill/Finish Operations.
  • Develop, revise, and review SOPs, qualification/validation protocols and reports.
  • Monitor and report data for Quality Management Review
  • Prepare of dossiers and data packages for interactions between Tessa and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Perform other duties as required.
Requirements
  • PhD in Biotechnology/ Biomedical Science/Cell Biology/Science related field with at least 8 years of Quality experience or Master’s degree with at least 15 years’ of Quality experience in the biotech and/or pharmaceutical industry
  • At least 5 years of direct experience, including supervisory experience of leading a team, in Fill/Finished operations
  • Working knowledge of quality systems and regulatory requirements for sterile operations (21 CRF Part 11/210/211 EMA, HC & PIC/S)
  • Broad cGMP experience is preferred, with working knowledge and understanding of Production, Quality Control, and Validation requirements and activities
  • Strong knowledge of technical writing for BLA and IND
  • Proficient in identifying, evaluating, and closing OOS’s and investigations
  • Strong knowledge of cell culture techniques
  • Strong knowledge of Validation Protocols IQ/OQ/PQ/PV for equipment and utilities
  • Proficient in MS Word, Excel, Power Point, and other applications

Soft Skills

  • Ability to communicate and work independently with scientific/technical personnel.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal, and written communication skills