Associate Director / Senior Manager, Quality Control (Microbiology & Environmental Monitoring)

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies. We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

Job Position
Associate Director / Senior Manager, Quality Control (Microbiology & Environmental Monitoring)

Reports To
Director, Quality

Responsibilities

  • Responsible for managing Microbiology Laboratory and EM teams.
  • Responsible for development of site Environmental and Utility monitoring programs and policies. Ensures sampling plans are up to date and executed as planned.
  • Owns site environmental monitoring and utility trend program. Hosts monthly trending meetings, responsible for sharing trend information with the site Quality team and identifies and escalates adverse trends appropriately. Drives corrective/preventative actions, ensuring work is complete and the site remains in a state of control.
  • Responsible for ensuring Microbiological Method Validation, Laboratory compliance and ensure data integrity.
  • Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems. Reviews records for accuracy and compliance with cGMP and Tessa policies and SOPs.
  • Leads environmental excursion investigations. Ensures corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings.
  • Writes, reviews, and/or approves SOPs, sampling plans, and protocols.
  • Develops and maintains a tool for monitoring QC resource capacity. Provides feedback to QC management when capacity constraints exist.
  • Proactively evaluate the laboratory’s quality systems for gaps in current compliance standards and/or industry trends for compliance. If gaps are identified, mitigate these gaps. Capable of hosting tours of the micro-laboratory by regulatory or client auditors and serve as a Subject Matter Expert (SME) if called upon.
  • Proactively develop staff. Coach and provide feedback on job performance. Complete annual performance evaluations and identify development opportunities. Sets and delivers on individual and team goals that support the department and site strategy. Assist with training new hires and cross-train existing staff.
  • Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
  • Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance.
  • Monitors and evaluates current regulatory requirements, making recommendations for improvements when necessary.
  • Enforces regulatory compliance.
  • Excellent communication, interpersonal and organizational skills.
  • Proactive at keeping current with literature and latest technologies.
  • Work well both independently and in a team environment.
  • The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Requirements

  • Degree in life science discipline (Master’s degree preferred) or any related field with at least 10 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 bacterial endotoxin, bioburden, sterility testing and environmental monitoring is required.
  • Demonstrated knowledge in Pharmaceutical Microbiology as it relates to Environmental Monitoring, Aseptic Processing, Cleanroom design and behaviour.
  • Experience with technical investigations.
  • Experience in Cell Therapy facilities will be an added advantage but not mandatory.
  • Ability to prioritize work and multitask.
  • A demonstrated ability to supervise, train, and manage technical staff.
  • cGMP audit experience in USFDA, EU and HSA etc.
  • Experience in clean room qualification, protocol/sampling design and technical investigations.
  • Excellent communication, interpersonal and organizational skills.