• Intern, 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
    Intern, Manufcaturing

    Reports To

    Senior Manager / Manager, Manufacturing

    Responsibilities

    • Develop and maintain Job aids, Training materials and curricula related to process operations, and process theories with the support of Manufacturing Managers and MFG Specialist / Biotechnologists.
    • Create Safety Risk Assessment (using tools such as pFMEA, HAZID, HAZOP) related to usage of process equipment and process operations.
    • Support and perform cell manufacturing related activities according to written Batch Manufacturing Records (BMRs) and associated Standard Operating Procedures (SOPs).
    • Adhere to strict aseptic techniques and sterile manufacturing guidelines when performing cell therapy production in the Training Lab or Good Manufacturing Practice (GMP) cleanroom facility.
    • Document production activities and outcomes using Good Documentation Practices (GDP) in the corresponding batch records and log sheets
    • Clean and perform basic maintenance of process equipment and cleanroom according to SOPs
    • Assist and perform inventory planning and control in the cleanroom through Kanban and 5S workflows.
    • Assist in Quality Management System aspects of cleanroom management including deviation investigations, CAPA implementation and change control assessments.

    Requirements

    • Degree in Pharmaceutical Engineering/Biotechnology/Chemical Engineering/Bioengineering/Life Sciences or any related field.
    • Previous experience in the biopharmaceutical or related environment is a plus. Applicant must be familiar with a GMP environment and compliance expectations in a cleanroom manufacturing area.
    • Competent in MS Excel (able to use Pivot Tables, Condition Formatting and other basic formulas), MS Word (familiar with the use of Styles, and other basic formatting tools) and MS PowerPoint.
    • Good communication skills and able to be a team player.
    • Passionate, self-motivated and willingness to learn.
    • Ability to work long hours occasionally when required.
    • Strong technical writing abilities.
    • Good analytical, planning and coordination skills.
  • Senior Manager / Manager, Clinical Project

    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, Clinical Project

    Reports To

    Associate Director, Clinical Operations

    Position Summary

    This individual will be responsible for the planning and executing of trials for the Clinical Operations function. He/she will work closely with multi-disciplinary departments and will require a solid understanding of the clinical trial lifecycle management such as study startup, feasibility, site selection, patient recruitment, project management, site management and site quality oversight. He/she will also be overseeing CROs and other related third-party vendors which are delegated to execute studies on Tessa’s behalf.

    Job Descriptions:

    • Ensure that global clinical strategies are translated to study specific strategies.
    • Ensure that the trials are run in adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs and policies.
    • Provide operational input into study designs, protocols and study plans to ensure that they are operationally feasible at the country, site, and patient levels
    • Oversees the execution and adherence to all integrated study operation plans, with inputs from key stakeholders.
    • Oversee the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with CRO Management and key stake holders
    • Set Key Performance Indicators (KPIs) and roll out metrics to track the quality and performance of the studies.
    • Monitor study progress, study budget, study timeline
    • Identify quality and deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.
    • Establish good working relationships with the participating sites and be the point of sponsor contact escalated site issues.
    • Conduct regular onsite monitor assessment visits.
    • Provide inputs into responses for site audit report and Inspection report as well as be responsible for oversight of associated plans

    Requirements

    • Bachelor Degree in a field of Biomedical science, pharmacy, nursing, or medical related courses.
    • At least 10 years’ experience working in clinical research and at least 4 years of clinical project management experience in oncology studies.
    • In depth knowledge of oncology trials requirements, clinical research principles such as ICH GCP as well as regulatory requirements.
    • Strong communication and influencing skills
    • Strong organizational and problem-solving skills
    • Strong supervision and oversight skills
    • Effective presentation skills
    • Strong ability to deliver results to the appropriate quality and timeline metrics
    • Good judgment
    • Ability to manage competing priorities
    • Experiences in immuno-oncology and/or gene and cell therapy studies are advantages.
    • Proficiency in MS Excel required, programming knowledge an advantage
  • Intern, Process Sciences and Technology

    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
    Intern, Process Sciences and Technology

    Reports To

    Senior Manager, MSAT Process

    Responsibilities

    • Support PSAT in characterization of process parameters to support the BLA submission data package.
    • Support in the development of process troubleshooting and process monitoring trending systems and tools
    • Support PSAT in Tech transfer for new process / 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.

    Requirements

    • Diploma/Degree in Engineering or Biotechnology or any related field
    • Knowledge with cell therapies/immunology is preferred. Alternatively, strong ability to learn.
    • 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.
  • Intern, Process Sciences and Technology

    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
    Intern, Process Sciences and Technology

    Reports To
    Expert, MSAT Validation

    Responsibilities

    • Responsible for creation of testing instruments SOPs used in validation. Execution of temperature mapping studies. Compilation and presentation of validation data.
    • Support the creation of validation/study protocols. Support the creation of EHS risk assessment related to validation activities.
    • Maintain the validation project deliverables and validation inventory.
    • Establish Visual board to facilitate validation operations / projects
    • Communicate regular progress reports of assignments

    Requirements

    • Proficient in Microsoft words, excel and powerpoint
  • Senior Executive, Human Resource

    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 Executive, Human Resources

    Reports To
    Vice President, Human Resources

    Responsibilities

    Talent Acquisition

    • Implement a comprehensive recruitment plan consistent with the strategic vision of Tessa
    • Business partner with hiring manager and business departments to develop a strategic sourcing strategy
    • Utilise creative and non-traditional recruitment strategies to help build an experienced, skilled, and diverse talent pool
    • Source resumes through various forms of media including online databases and networking with numerous organisations locally and internationally.
    • Establish and maintain successful relationships with educational institutions, search firms, professional associations and other organisations that provide recruitment value.
    • Manage recruitment projects and initiatives.
    • Assist hiring managers with status updates, applicant repositioning and other common requests.
    • Professionally represent Tessa at local and international job fairs, conventions and conferences and maintain positive relationships with internal and external contacts
    • Maintain a solid understanding/knowledge of the Tessa Culture. Be a brand ambassador and communicate the company philosophy of development and growth to potential candidates
    • Implement online and offline employer branding activities
    • Prepare and review annual recruitment budget

    Business Partner

    • Responsible for aligning business objectives with employees and management in designated business unit.
    • Formulates partnerships across the HR function to deliver value-added service to management and employees that reflects the business objectives of the organization.
    • Consults with line management, providing HR guidance when appropriate.
    • Analyses trends and metrics in partnership with the HR group to develop solutions, programs and policies.
    • Manages and resolves complex employee relations issues. Conducts effective, thorough and objective investigations.
    • Provides day-to-day performance management guidance to line management (e.g., coaching, counselling, career development, disciplinary actions).
    • Works closely with management and employees to improve work relationships, build morale, and increase productivity and retention.
    • Provides HR policy guidance and interpretation.
    • Provides guidance and input on business unit restructures, workforce planning and succession planning.
    • Identifies training needs for business units and individual executive coaching needs.
    • Participates in evaluation and monitoring of training programs to ensure success. Follows up to ensure training objectives are met.

    Requirements

    • Degree in Human Resources Management or relevant field or proven work experience in Talent Acquisition or similar role
    • 5 years’ experience in Talent Acquisition and Business Partnering.
    • Demonstrable experience managing full-cycle recruiting and employer branding initiatives
    • Solid understanding of sourcing techniques and tools
    • Good team-management abilities
    • Excellent communication skills with the ability to foster long-term relationships (with internal teams, external partners and candidates)
    • Self-starter; ability to work in a fast-paced and dynamic environment
    • Proficient in the use of job boards and various forms of media for recruiting/ branding purposes
    • Excellent communication skills, both written and verbal
  • 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
  • Senior Executive, Quality Control (Raw Materials)

    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 Executive, Quality Control (Raw Materials)

    Reports To
    Senior Expert, Materials Testing

    Responsibilities

    • Establish and maintain QC laboratory in full cGMP-compliance
    • Support testing coordination for incoming materials, both internally and externally to ensure the testing can be completed timely to meet production need.
    • Ensure incoming materials sampling is performed in accordance to written sampling plan and in accordance with local/ international regulations
    • Ensure samples are distributed to testing laboratories, both internal or external laboratories in a timely manner
    • Conduct wet chemistry and spectroscopic testing, as required
    • Participate in the validation of internal test methods with external contract lab, as well as in-house method verification of compendial methods, as required. Assist in preparation and reviewing of method qualification protocols and reports
    • Ensure incoming materials have been tested or inspected according to specifications and current approved test method. Perform required data review, compile data and prepare results for review.
    • Assist in the installation of laboratory equipment and qualification of laboratory equipment for intended use in QC laboratory, as required
    • Support non-conformance investigations, corrective and preventative actions and change controls as required
    • Review QC documents to ensure completeness, accuracy, consistency, and clarity
    • Participate in projects for continuous improvement initiatives within QC department
    • Maintain the inventory management and retain sample accurately.
    • Prepare and participate to health authority’s inspections and internal audits in QC Raw Material area

    Requirements

    • Master’s degree/ Bachelor’s Degree in Life science, Microbiology, Biotechnology or Chemistry or any related field with at least 5 years of relevant working experience in pharmaceutical GMP-regulated industries.
    • Prior experience in Quality Control Raw Materials lab is preferred
    • Ability to perform analysis of USP and EP pharmacopeia methods
    • Proven ability to effectively collaborate, multitask and work in a fast-paced environment.
    • Must be well-organized and pay close attention-to-detail.
    • Excellent written and oral communication skills.
  • 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.
  • 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 Manager / Manager, Clinical Project

    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, Clinical Project

    Reports To
    Associate Director, Clinical Operations and Data Management

    Summary

    This individual will be responsible for the planning and executing of trials for the Clinical Operations function. He/she will work closely with multi-disciplinary departments and will require a solid understanding of the clinical trial lifecycle management such as study startup, feasibility, patient recruitment, project management, site management and site quality oversight. He/she will also be overseeing CROs and other related third-party vendors which are delegated to execute studies on Tessa’s behalf.

    Responsibilities

    • Ensure that global clinical strategies are translated to study specific strategies.
    • Ensure that the trials are run in adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs and policies.
    • Provide operational input into study designs, protocols and study plans to ensure that they are operationally feasible at the country, site, and patient levels
    • Oversees the execution and adherence to all integrated study operation plans, with inputs from key stakeholders.
    • Oversee the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with CRO Management and key stake holders
    • Work closely with the CRO to manage China sites and have face to face meetings with Chinese doctors.
    • Set Key Performance Indicators (KPIs) and roll out metrics to track the quality and performance of the studies.
    • Monitor study progress, study budget, study timeline
    • Identify quality and deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.
    • Establish good working relationships with the key participating sites and be the point of sponsor contact escalated site issues.
    • Conduct regular onsite monitor assessment visits.
    • Provide inputs into site audit report responses and responsible for oversight of associated plans

    Requirements

    • Bachelor’s Degree in a field of Biomedical science, pharmacy, nursing, or medical related courses with at least 10 years’ experience working in clinical research and at least 4 years of clinical project management experience in oncology studies.
    • In depth knowledge of oncology trials requirements, clinical research principles such as ICH GCP as well as regulatory requirements.
    • Strong communication and influencing skills
    • Strong organizational and problem-solving skills
    • Strong supervision and oversight skills
    • Effective presentation skills
    • Strong ability to deliver results to the appropriate quality and timeline metrics
    • Good judgment
    • Ability to manage competing priorities
    • Experiences in immuno-oncology and/or gene and cell therapy studies are advantages.
    • Proficiency in MS Excel required, programming knowledge an advantage