Senior Manager/Manager, Manufacturing

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

Senior Manager/Manager, Manufacturing

Reports To
Head of Manufacturing

As a Manufacturing Manager in a growing and dynamic team, you will use your passion, creativity and diverse industry experience to streamline and develop innovative manufacturing processes to cater for the needs of autologous therapies while being compliant to cGMP requirements. You will lead and guide the team to ensure excellent standards of manufacturability, cleanroom operational efficiency, yield improvement, failure analysis, while identifying opportunities for advanced process controls, cost reduction, and automation of unit operations together with the Process Development team. You will also collaborate with other multi-disciplinary teams to maintain strong functional relationship to co-develop and structure future requirements for product commercialisation.

With your passion in people management and focus on collective interest, you will guide, develop and mentor your fellow colleagues to ensure a highly collaborative, professional and high performing team that will deliver excellent results while establishing a positive and high energy workplace environment.

Responsibilities

Manufacturing Operations

  • Lead and manage activities on the manufacturing floor;
  • Accountable for day-to-day Manufacturing activities while complying to Quality, cGMP and EHS requirements;
  • Management and planning of manufacturing activities, namely – (1) schedule and capacity planning, (2) patient sample production status, (3) oversee and review batch records and (4) efficient allocation of manpower and resources;
  • Effective Change Control and Project Management (1) initiate, design and oversee the smooth implementation of manufacturing change controls, (2) manage and review interdepartmental change controls;
  • Effective management of deviation reporting, guide and lead team to – (1) appropriately raised deviations when required, (2) conduct thoughtful and meaningful RCA and CAPA relating to deviation;
  • Technical writing of SOPs, Batch Record, Investigation Reports, amongst others (when required; example for new pipeline product launch, etc);
  • Drive manufacturing related workplace Health, Safety, and Wellness (including ergonomics) initiatives together with the in-house EHS representatives.;
  • Drive and seek continuous improvement of all processes and workflows to achieve stable, lean and efficient manufacturing and business processes;
  • Collaborate with other departments to achieve the overall goals for operations;

Strategy, Planning and Business Development

  • Jointly develop and execute manufacturing strategies for new cell therapy products tech transfer programs, GMP manufacturing processes, automation initiatives, amongst others;
  • Develop, plan and implement manufacturing operations and business processes for new facility start-up. SOPs, workflow and processes will be critically thought out to cater for cell therapy products and appropriate for clinical and commercial manufacturing;
  • Jointly lead and drive commissioning, qualification and validation activities for new sites;

Management and People Development

  • Actively and jointly participate in the preparation and management of department’s goals, project, budget and others;
  • Providing clear, organised and meaningful updates and analysis on manufacturing-related operations and projects to facilitate decision-making at the Technical Operations or Program level;
  • People development and management, including – (1) recruitment and talent development, (2) developing supervisors and team leaders, (3) provide mentorship, (4) carry out performance review, and (5) ensure team succession and backup.

Requirements

  • Bachelors, Masters, or PhD in Life Science / Biomedical Sciences / Chemical Engineering / Bioengineering / Bio-processing and other relevant scientific or engineering disciplines;
  • 7–10 years of relevant cell and gene therapy (or biologics) clinical / commercial manufacturing experience;
  • At least 4 years of leadership experience with track record of building and leading exceptional teams;
  • Extensive experience in GMP cleanroom operations and aseptic processing;
  • Strong knowledge and experience in cell therapy manufacturing (or upstream cell culture processes) and cryopreservation;
  • Strong working knowledge of cGMP guidelines and relevant regulatory knowledge (FDA, EMA, PICS);
  • Highly skilled in applying Root Cause Analysis tools and in designing meaningful CAPAs;
  • Technical writing skills for the authorship of internal/external documents and approve technical documents;
  • Knowledge of T cell biology and immunology will be advantageous;
  • Highly proficient with Microsoft Office Suite and able to efficiently utilise MS Excel, MS Word, or MS PowerPoint for presentation and management reporting.
  • Team player with strong work ethic and thrives in intellectual challenges;
  • Strong interpersonal skills and ability to develop important relationships with key stakeholders, good conflict management and negotiation skills;
  • Excellent communication and presentation skills. Able to communicate ideas, problem statements and plans clearly and effectively for decision-making / determination of path forward. Communication should be relatable and factor in perspectives and interests of a multi-disciplinary group;
  • Excellent critical thinking and problem-solving skills. Able to critical assess situations and approach solving problems with first principles;
  • Outstanding organisation and time management skills with demonstrated ability to manage and prioritise multiple tasks and projects;
  • Highly motivated and self-driven with proven track record of delivering complex projects and working with multi-disciplinary teams