Manufacturing Manager

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create 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 Manufacturing team.

 

Job Position
Manufacturing Manager

Reports to
Head of Manufacturing

Location
Malaysia

Position Summary

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

  • Co-lead the manufacturing activities of 3 processing suites;
  • 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 release and (4) efficient allocation of manpower and resources;
  • Effective management of change control (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;
  • Process monitoring including – establishment and oversight of databases, documents and/or spreadsheets to support process trending and business reporting requirements
  • Author technical documents for procedures and equipment such as SOPs, Batch Record, Investigation Reports, etc;
  • Drive manufacturing related workplace safety initiatives;
  • 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;
  • People development and management, including – (1) hiring of new workforce, (2) developing supervisors and team leaders, (3) provide mentorship, (4) carry out performance review, and (5) ensure team succession and backup.
  • Assist HOD in the preparation and management of department’s goals, project, budget and others.

Basic Qualification(s)

  • Bachelors / Masters / PhD in Immunology in Cell Biology, Molecular Biology, Chemical Engineering, Bioengineering, and other relevant scientific or engineering disciplines;
  • 7–10 years of relevant cell therapy (or biologics) commercial manufacturing experience and at least 3 years of experience managing a manufacturing team;
  • Excellent working knowledge of cGMP guidelines and relevant regulatory knowledge (FDA, EMA, PICS);
  • Excellent knowledge of cell culture and principles of aseptic processing in a classified environment;
  • Expert knowledge in electronic business reporting and quality systems (e.g. Trackwise, SAP).

Preferred Qualification(s)

  • Hands-on experience with primary cell culture;
  • Knowledge of T cell biology and immunology will be extremely advantageous;
  • Highly skilled in applying Root Cause Analysis tools (e.g. DMAIC, time series, pareto analysis, etc) and in designing meaningful CAPAs;
  • Lean / Six Sigma experience and certifications is a plus;
  • Technical writing skills to support authorship of internal/external documents and approve technical documents;
  • Strong communication and interpersonal skills; ability to develop important relationships with key stakeholders, good conflict management and negotiation skills;
  • At least 3-5 years in people management and leadership roles with track record of building and leading exceptional teams;
  • Able to build and manage a team as well as train entry-level personnel.