• Manager / Senior Scientist , Process Development

    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
    Manager / Senior Scientist , Process Development

    Reports To
    Senior Director, Process, Science & Technology

    Responsibilities

    As part of the process development, the successful candidate will be leading a team of scientist in the area of cell therapy process optimization efforts in areas such as – (i) characterize product and processes, (ii) improve predictive consistency and workflow efficiency, (iii) product characterisation, (iv) automation strategies, among others.

    What you will do:

    • Independent hands-on bench work in the isolation, culture (tissue culture vessels, bags, bioreactors), and characterization of cells under cGMP conditions
    • Lead and guide team members to identify, design and execute technical and methodological solutions to a wide range of complex manufacturing issues; including transition and implementation to GMP-compliant use
    • Develop and execute scientifically sound strategies for (i) process comparability relating to late stage regulatory submissions, and (ii) raw material qualification for clinical and commercial manufacturing
    • Organize team to perform characterization studies of final product T cells
    • Provide scientific guidance to the team on the methodology for executing experiments
    • Evaluate automation technologies for implementation into process development
    • Create and manage documents and raw data for future reference or for use in developing central technical documents. This includes ensuring data is regularly checked and verified by a second person.
    • Use external and internal references to create technical assessments and justifications for the process and product.
    • Report and escalate issues impacting and resulting in delays in the timelines
    • Support manufacturing investigations as required.
    • Work collaboratively with other departments and within the PSAT department to achieve the goals, including the transfer of processes to manufacturing.

    To excel you will need to:

    • Be able to bridge scientific aspect of T cell immunology with GMP manufacturing requirements.
    • Think beyond the scientific scope toward cGMP requirements.
    • Lead, manage and prioritize activities in the team to meet objectives and timeline
    • Develop templates, systems and platforms required for smooth running and tracking of department activities
    • Develop and execute detailed project plans (including budget and resource requirements)
    • Provide timely status reports, presentation and analysis to department head
    • Support department head in other strategic department initiatives
    • Provide guidance and supervision junior staff or manufacturing biotechnologist in areas of:
      • Cell culture techniques and scientific knowledge
      • Writing of technical reports and presentation
      • Preparing SOP, batch records and product specifications documentation in compliance to cGMP guidelines
      • Others

    Requirements

    • PhD. in biological science, immunology, T cell therapy, chemical/biological engineering or other related scientific discipline (Bachelors and Master’s degree are welcome to apply)
    • At least 5 years of relevant industry experience
    • Exceptional aseptic technique and primary cell culture skills, with experience in:
      1. handling cells populations typically include T cells, dendritic cells and derivatives thereof intended for infusion, and
      2. use of well plates, T flask, and other small scale bioreactors
    • Experience with automated, large scale cell processing and selection systems for processing human blood products
    • Hands on experience in flow cytometry/ Immunoassays like cytokine release assays
    • Good understanding of principles of cGMP, FDA compliance, raw materials and documentation requirements
    • Excellent organizational and problem solving skills
    • Details oriented and able to work effectively in a fast paced, rapid changing environment
    • Good collaborative, interpersonal and communications skills
    • Highly proficient in MS Word, Excel, PowerPoint, SharePoint, Outlook
    • Exhibit and promote Tessa’s Core Values
    • Proficient in statistical analysis and technical writing
    • Travelling is a must and willingness to have a flexible schedule when needed
  • Associate Director / Senior Manager, External Manufacturing Operations

    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, External Manufacturing Operations

    Reports To
    Senior Director, Process, Science & Technology

    Responsibilities

    • The candidate will support the execution various external manufacturing projects related to clinical pipeline programs. The candidate will lead a cross-functional team that is responsible for external manufacturing.
    • The scope of activities includes external cell therapy manufacturing, satellite laboratories for process, vector and cell bank manufacturing as well as potential collaborator transfers.
    • The phases of activities will include:
      • Lead the selection, contracting, setup and operational liaising of external contract manufacturing organizations (CMOs).
      • Serve as a point of contact for contractual issuance, quality issues and escalation of issues.
      • Support technology transfer of processes where required. Potentially lead the activity depending on the scale and complexity
      • Ensure the qualification or acceptance of manufacturing activities where required before moving into the operational phase
      • Monitor operations, ensuring systems are synchronized between satellite laboratories and external manufacturing sites.
      • Ramp down and closure of projects to ensure proper procedures are adhered to and contracts closed out, including transfer of necessary intellectual property, operational data or quality documents.Be part of and help nurture an environment where individuals and teams can grow and excel.
    • The individual will organize and coordinate various activities amongst the Tessa functions including:
      • Ensures necessary communication within the project team (meetings, reporting) and coordinates interfaces outside of the project team with core team members, steering team members and stakeholders.
      • Responsible for joint steering team for meeting project objectives
      • Report project progress to all key stakeholders, escalating key issues and risks for the project.
      • Supports the technical team to investigate any project challenges with necessary risk assessment tools and techniques then implements corrective measures
      • Evaluates and assesses project results and provides recommendations for future improvement as part of a continuous improvement effort
      • Closely monitor/control project progression to ensure projects are completed on schedule and within budget
    • Be part of and help nurture an environment where individuals and teams can grow and excel.

    Requirements

    • Degree in Engineering or Biological Sciences any related field with at least 10 years of relevant working experience in technical project management, operations with contract development or manufacturing organizations (CDMOs) or collaboration partners.
    • Technology transfer and/or early clinical stage program experience is required
    • Able to juggle 2 or more programs simultaneously, depending on complexity and size of trial
    • Understanding of cell therapy or gene vector processes ideal.
    • Prior experience in cGMP Biologics facilities, quality assurance and working with contract organization and vendors a must.
    • Proactive in working on solving issues and problems
    • Able to work in a matrix environment and handle ambiguity
    • Able to communicate with impact, ensuring alignment and negotiating positive outcomes from various stakeholders.
    • Familiar with CMO selection and contracting processes
    • Comply to Tess safety practices and standard operating procedures
    • Exhibit and promote Tessa’s Core Values
    • Travelling up to 15% may be required
  • Senior Expert / Expert, MSAT Process

    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 Expert / Expert, MSAT Process

    Reports To
    Senior Manager, MSAT Process

     Job Description

    • Responsible for technical support to manufacturing operations to ensure that processes meet cGMP requirements and the product Critical Quality Attributes (CQAs) are met. The scope of activities includes
      • data collection,
      • process monitoring,
      • technical assessment troubleshooting of issues related to Tessa Therapeutics Cell Therapy product(s).
      • specifically, execute for process qualification, process monitoring, and optimization activities related to our Phase III manufacturing activities.
      • Tech Transfer for new product or facility
    • Responsible for mentoring Junior team member, including providing technical decision making.
    • Provide timely technical assessment for deviations, change control, and qualification activities
    • Accountable for timely support and closure of process related deviation, change control, qualification and Technology Transfer activities.
    • Support quality, process development and manufacturing operations in ensuring the process control strategy is maintained and monitored, including at-line product and process characterization.
    • Support in the development of process troubleshooting and process monitoring trending systems and tools that align with the QMS and are part of the continued process verification plan (CPV).
    • Support or lead Technology transfer for new product / facility
    • Maintain strong working relationships with inter-department stakeholders as well as external contractors
    • Communicate effectively across functions. Align goals and priorities for the timely execution of activities. Engage in both technical and tactical discussions to ensure stakeholder alignment.
    • Excellent team player with willingness to learn, share and find solutions together with the team.
    • Participate in organizational activities including due-diligence meetings, organizational development and team building activities to further the culture of Tessa Therapeutics.

    Requirements

    • Master’s degree/Degree in Engineering or Biotechnology or any related field with at least 5 years of relevant working experience
    • Experience with cell therapies preferable alternatively, strong ability to learn.
    • Prior experience in process troubleshooting, deviation writing and executing change controls, particularly in a clinical or commercial manufacturing setting.
    • Experience in process monitoring
    • Experience in tech transfer
    • Flexible and proactive in working on solving issues and problems, particularly using Six Sigma tools (e.g. DMAIC).
    • Able to communicate with impact, ensuring alignment and negotiating positive outcomes in his/her area of work.
    • Good time management
    • An excellent team player with willingness to learn, share and find solutions together with the team.
    • Ability to work independently with minimum supervision.
    • Proficient in statistical analysis and technical writing.
    • Requires to travel up to 20% of the job