Manager/Lead, Quality Control (Bioanalytical)

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
Manager/Lead, Quality Control (Bioanalytical)

Responsibilities

  • Responsible for overseeing the Quality Control Bioanalytical (bioassay and analytical testing) Team which includes raw materials, in-process and finished product testing.
  • Owns QC related polices and procedure of the assigned QC processes which include product testing, materials testing, method qualification/validation, lab investigations, stability testing, LIMS, lab equipment qualification and/or calibration.
  • Ensure timely completion of assigned activities which include testing, method qualification/validation, equipment qualification or computer systems validation as per agreed lead-time/milestones.
  • Initiates/Reviews/approves procedures, documents, records, deviations, investigations, corrective action/preventive actions, changes controls and risk assessments.
  • Ensure QC personnel are qualified and trained to perform assigned tasks
  • Support product/materials testing, methods qualification/validation activities, equipment qualification activities or other QC related activities as an executor, reviewer and/or approver.
  • Ensure products are tested and assessed per applicable current GxP and regulations.
  • Serve as key subject matter expert in assigned QC system(s), equipment, process(es).
  • Ensures that facilities, equipment, materials, processes and procedures that are applicable to QC comply to applicable, current GxP regulations
  • Manage performance and development of direct reports to ensure achievement of organizational goals
  • Supports improvement initiatives, programs and projects driven from the Quality Management System

Requirements

  • Degree in Chemistry, Microbiology, Pharmacy, Pharmaceutical Science, Biotechnology or equivalent
  • Preferably more than 6 years of relevant work experience in Quality Control (and in which more than 3 years are in the supervisory role) in the pharmaceutical processing/biotechnology manufacturing/medical device manufacturing.
  • Good interpersonal and leadership skills
  • Advanced knowledge in regulatory requirements e.g. FDA, EMA, ICH requirements
  • Growth mindset, able to think strategically when dealing with challenges and solving problems
  • A team player with excellent coordinating & organizing skills, able to work independently and / or within team(s)
  • Effective oral and written communication skills