Technical Lead (Drug Product Sterile Filling)

About Tessa Therapeutics

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
Technical Lead (Drug Product Sterile Filling)

Responsibilities

  • Lead the technology transfer of sterile products into the Tessa’s sterile filling line. Tessa’s filling line will include bulk thaw, compounding/formulation, sterile filling and visual inspection. The incumbent will:
    • Work with the internal or external transferring unit on facility/equipment fit gap assessment and process transfer gap assessment.
    • Work with project manager to determine timelines for appropriate transfer of processes, assays and align internally on various feasibility testing activities and qualification activities.
    • Represent the organization in discussions with transferring unit to outline requirements, propose/troubleshoot process issues.
    • Work with the automation, validation, manufacturing, and quality teams to ensure timely transfer of the process, GMP readiness and delivery of sterile filled product.
  • Support start-up activities, commissioning/qualification, and validation activities, in particular:
    • Isolator decontamination, set-up of single-use wetted path filling systems
    • Optimization of Ready-to-Use debagging, vial transfer, vial/stopper/seal filling activities
    • Semi-automatic visual Inspection system setup including defect/Knapp set establishment
    • Sterile filtration setup/ testing and validation
  • Assist in training operators as well as review of relevant GMP documents including SOPs, forms, etc
  • Creation of product specific documents, including process flow charts/ material tracking/time out of refrigeration tracking requirements, CPP/CQA risk assessments.
  • Support first-in-GMP manufacturing batches as well as assist in investigations, change controls and CAPAs
  • Generate reports/technical evaluations to the transferring unit/ customer where required.
  • Regular communication to stakeholders and alignment on activities and deliverables based on project plans.
  • Support validation in defining requirements for qualification/engineering batches
  • Adhere to Tessa’s Quality and EHS policies.

Requirements

  • Minimum Degree in Engineering
  • Minimum 6 years of fill/finish experience in biopharma or pharmaceutical plant preferably with technology transfer of products
  • Experience commissioning/qualification of filling equipment/isolators and visual inspection equipment.
  • Knowledge in fill finish process equipment in particular, isolator based filling equipment
  • Knowledge in visual inspection qualification
  • Team leadership experience or cross-functional team experience required
  • Strong technical communication skills required
  • Experience in using PLC and SCADA platforms like Allen Bradley/ Rockwell, Siemens, and Schneider
  • Experience in Six Sigma methodologies a plus
  • Strong problem solving and troubleshooting skills