Senior Manager, Quality Control (CMO)

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
Senior Manager, Quality Control (CMO)

Responsibilities

  • Direct liaison with the QC team within the Contract Manufacturer Organization (CMO) for all QC related activities in supporting the manufacturing process.
  • Responsible for leading, coordinating and managing all activities associated with QC testing and release during the routine phase.
  • During the tech transfer phase, to work closely with the Tessa tech transfer team and the CMO tech transfer team in ensuring all QC test methods are being transferred and qualified/validated prior to being used to support clinical and commercial manufacturing.
  • Responsible for the development of relevant procedures necessary to support the CMO activities.
  • Responsible for reviewing QC test reports, test protocols and other associated documents generated from the CMO for the purpose of supporting QC testing at CMO.
  • Coordinate/perform method monitoring/trending for identified parameters to ensure methods reliability.
  • Responsible for working with the CMO to ensure compliance with regulatory requirements.
  • Work with Tessa subject matter experts on the respective methods to provide technical advice to CMO, whenever necessary.
  • Approve and authorize specifications, sample instructions, methods and other Quality Control procedures, including changes related to the outsourced manufacturing processes.
  • Ensure necessary equipment qualification and assay validations are complete, provide oversight as necessary to the CMO.
  • Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA) associated with the outsourced manufacturing processes
  • Monitors and evaluates current regulatory requirements, making recommendations for improvements when necessary.

Requirements

  • Bachelor or Postgraduate degree in life science discipline or any related field
  • At least 7 years of relevant working experience in a highly regulated cGMP regulated environment (Biologics and Pharmaceuticals etc).
  • Good understanding of current regulatory requirements of GMP Biologics and Pharmaceutical industries
  • Experience with biochemical analysis which includes immunoassay, cell-based assay etc
  • Experience in Cell Therapy facilities will be an added advantage but not mandatory
  • Experience with technical investigations
  • cGMP audit experience in USFDA, EU and HSA etc.
  • Demonstrate strong leadership, communication and organizational skills
  • Ability to prioritize work and multitask
  • Work well both independently and in a team environment