Job Position
Associate Research Scientist

Reports To
Senior Research Scientist

Responsibilities

• Planning, managing, and conducting research project(s)
• Perform cellular and molecular biology experiments such as cell culture, flow cytometry, and/or molecular cloning.
• Perform and/or assist data analyses and report writing.
• Assist in broad level of laboratory management as well as solving of any operational issues, as required.

Requirements

• Bachelor’s degree in Immunology, Molecular biology or other relevant areas of Biomedical fields prior experience in R&D desirable
• Molecular biology experience in cell culture, western blot, immunoprecipitation, viral vector biology, mammalian cell transfection, PCR and Golden Gate cloning
• Strong background in immunology and/or molecular biology and/or Virology
• Strong analytical skills and possess good scientific writing and presentation skills
• Good working attitude and willingness to learn
• Good problem solving skills
• Good communication skill and able to be a team player
• Self-starter and independent learner
• Independent data analysis
• Careful record keeping

Job Position
Director, Regulatory Affairs

Reports To
Global Head, Regulatory Affairs

Responsibilities

• Responsible to develop US regulatory filing strategy for the assigned genetically modified cell-based cancer immunotherapy products; compile and submit regulatory documents to the US FDA according to current regulatory requirements and applicable timelines;
• Serve as a liaison with the US FDA and ensure optimal early interactions with the Agency. Manage and oversee responses to regulatory authorities’ questions with strict deadlines and identification and mitigation of regulatory risk/gaps;
• Act as US Regulatory Program Lead for one or more of the products of the Tessa Therapeutics’ pipeline and responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials and product registrations; Identify and assess regulatory risks for assigned projects / programs;
• Involvement in Regulatory documents and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions;
• Oversee submission tracking information and inform program / project teams and senior management on real time status of business-critical submission;
• Coordinating the generation, edit, review and submission of INDs, DSURs, safety reporting, BLAs etc;
• Stay up to date with US regulatory requirements relevant for company pipeline/products, and interpreting and distributing regulatory intelligence to the internal teams;
• Develop detailed regulatory project plans and timelines and support regulatory activities relating to specific portfolio of products/projects;
• Participate as an active team member and provide regulatory support to cross-functional program and project teams as required on all aspects of Regulatory, CMC, non-clinical and clinical aspects during all stages of drug development;
• Contribute to the Target Product Profile and Quality Target Product Profile;
• Prepare and deliver effective presentations for external and internal audiences;
• Effectively communicate with internal stakeholders to lead and ensure regulatory strategy is understood, aligned with Program and Project milestones and implemented by the cross functional teams;
• Drives the interpretation and implementation of new regulatory agency guidelines and legislation relevant to regulatory submissions;
• Contribute to preparation and maintenance of Regulatory SOPs, working procedures and checklists related to templates, electronic submission processes and archiving.

Requirements

• Master in Pharmaceutical Sciences, Life Sciences or equivalent with at least 10 years in biopharmaceutical / pharmaceutical / biotech industry, in a similar role in Regulatory Affairs; or a PhD in Pharmaceutical Sciences, Life Sciences or equivalent with at least 7 years in biopharmaceutical/ pharmaceutical / biotech industry, in a similar role in Regulatory Affairs;
• US Regulatory expertise in Oncology, Immuno-oncology, Biologics Development, or Cell Therapy, Gene Therapy highly desirable.
• Experience in coordination, preparation and conduction of regulatory agency meetings with the US FDA and related materials is a must
• Ability to think strategically and to proactively identify issues in various aspects of the drug development process;
• Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects;
• Demonstrated effective cross-cultural awareness and capabilities;
• Technical system skills (e.g. word processing, spreadsheets, databases, online research);
• Experience in eCTD-compliant regulatory submissions;
• Experience in interacting with FDA in all phases of clinical development stages
• Experience in leading and managing complex filing projects within specific timeframe

Job Position

Senior Manager / Manager, External Manufacturing Projects

Reports to

Director, Strategy & Project Management

Job Description

• The individual will support the execution various external manufacturing projects related to clinical pipeline programs.
  • The role will involve ensuring satellite laboratories and the main manufacturing site are operating in synchronization as part of the clinical trial.
• The individual will organize and coordinate various activities amongst the technical 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.
  • Report project progress to all key stakeholders, escalating key issues and risks for the project.
  • Organize and coordinate deliverable from the various sub-teams, contractors and vendors.
  • 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 any related field with at least 8 years of relevant working experience in technical project management.
• Technology transfer and/or early clinical stage program experience is a plus
• Prior experience in cGMP Biologics facilities and working with contract organization and vendors a must.
• Proactive in working on solving issues and problems
• Able to communicate with impact, ensuring alignment and negotiating positive outcomes from various stakeholders.
• Comply to Tessa’s safety practices and standard operating procedures
• Exhibit and promote Tessa’s Core Values
• Travelling up to 15% may be required

Job Position

Manager / Senior Specialist, Quality Control

Reports to

Associate Director, Quality Control

Job Description

• Responsible for drafting protocols and reports for in-house assays method validation & qualification in accordance with cGMP requirements and applicable regulatory guidelines
• Works closely with QC analysts to plan, organize and execute the validation & qualification activities as per approved protocols and ensures resources are used efficiently and effectively for timely delivery of results meeting project timelines
• Supports the implementation of validated in-house assays and the establishment of associated workflow, standard operating procedures
• Establishes trend analysis of test results on the finished products, stability of drug substances & products supporting product quality review exercise
• Establishes program(s) and procedures to monitor the performance and manage the life cycle of in-house assays ensuring they are in a state-of-control
• Provides necessary technical expertise to support investigations of non-compliances, deviations and out-of-specifications
• Participates in technical transfer, assay development & qualification projects and response to regulatory queries pertaining to QC testing
• Attends and / or organizes inter-departmental or cross-departmental working group meetings and discussions relating to technical aspects of QC tests
• Be involved in technical training for junior team members

Requirements

• Master/Bachelor Degree in Biology/Life Science/Biochemistry/Biotechnology/Bioengineering or equivalent with at least 5 years of relevant experience in technical position in biopharmaceutical industry and cGMP environment
• In-depth knowledge and understanding in Cell & Molecular Biology and USFDA & ICH guidelines for method validation are required
• Hands-on experience in the following areas are preferred:
  • Quality Management System and Current Good Manufacturing Practice
  • US Pharmacopeia test methods for Cell, Gene & Tissue based products
  • QPCR and cell-based assays method validation
  • Statistical process control (SPC) and statistical analysis
  • Risk assessment (for example, FMEA)
  • TrackWise and LIMS computer systems
• Being in the leadership role for at least 2 years is strongly preferred
• A good team player with excellent planning, coordination and inter-person skills
• Being open-minded, resourceful and able to think strategically when dealing with challenges and solving problems
• Attention to details and able to undertake tasks timely and proactively
• Proficient in technical writing and presentation
• Able to work in a fast-paced environment and manage multiple projects
• Able to work with people from different background and levels

Job Position

Senior Specialist, Quality Control

Reports to

Associate Director, Quality Control

Job Description

• Works with all relevant GMP functions to establish qualification and monitoring program on control & testing of ancillary materials (AM) used in manufacturing
• Be responsible for establishment and implementation of AM control & testing associated workflow, standard operating procedures, specifications and sampling in accordance with cGMP requirements and applicable regulatory guidelines
• Oversees the operations of AM control & testing as per established procedures
• Works closely with materials supply teams ensuring coordinated and effective control over AM to meet operational needs
• Acts as subject matter expert in AM testing area in handling and supporting QMS associated activities including but not limited to audit, investigation, change control, deviation, CAPA, risk assessment, etc
• Leads a small team and provides training, coaching to junior team members
• Serves as the point-of-contact for coordination and communication of AM control & testing related matters with internal stakeholders and external contract laboratories
• Attends and / or organizes inter-departmental or cross-departmental working group meetings and discussions relating to AM control and testing
• Performs trending on non-conformances to ensure the validity of sampling plans meeting regulatory requirements
• Be Involved in budgetary projection and service & quality agreements relating to AM testing

Requirements

• Bachelor Degreer in Biology/Life Science/Biochemistry/Biotechnology/Bioengineering /Chemistry or equivalent with at least 5 years of working experience in materials control & testing in biopharmaceutical industry and cGMP environment
• Hands-on experience, strong knowledge and deep understanding in the following areas are preferred:
  • QMS and cGMP
  • USFDA and other regulatory requirements and guidelines for materials control
  • US Pharmacopeia for materials testing
  • Sampling plan and Skip-lot concepts
  • Sampling related statistical analysis
  • Risk assessment (for example, FMEA)
  • SAP or ERP, TrackWise and LIMS computer systems
• Prior experiences in materials control & testing in Cell Therapy or Biologics, being in a leadership role for at least 2 years with good people management skills are desirable
• A good team player with excellent planning, coordination and inter-person skills
• Being open-minded, resourceful and able to think strategically when dealing with challenges and solving problems
• Attention to details and able to take on the assigned tasks timely and play proactive role at work
• Proficient in technical writing and presentation
• Able to work in a fast-paced environment and manage multiple projects
• Able to travel with short notice if required

Job Position

Executive, Quality Control

Reports to

Manager, Quality Control

Job Description

• Responsible for generating purchase request, PO, as well as settling invoices for QC related testing
• Responsible for coordination of QC sample shipment and testing with external testing laboratories
• Supports QC laboratory operations for material-related matters, including new material sourcing, stock take, material usage forecast, material replenishment and reagent preparation
• Supports QC laboratory functions including cleaning and facility maintenance
• Participates in audits as required
• Acts as QC document controller through liaison with QA document control
• Sets up and manage electronic repository for QC documents
• Supports maintenance of TessaConnect QC site
• Assists in equipment maintenance and calibration matters
• Performs ad-hoc administrative duties as assigned

Requirements

• Diploma in Biotechnology/ Biological Sciences/ Biology/Life Science or any related field with at least 2 years of relevant experience
• Detailed and organized
• Good time management skill
• Proficient in Microsoft Word, Microsoft Excel, Microsoft Outlook
• Able to communicate pro-actively and effectively within department and with other departments, external vendors
• Able to adapt in a high-demanding and fast-pace working environment
• Knowledge in cGMP/ cGLP is preferable
• Preferably prior experience with SAP or any other purchasing/ finance computer system and LIMS system
• Able to perform duty on weekends or outside working hours if required

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,
  • deviation closure,
  • 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.
• Responsible for mentoring Junior team member, including providing technical decision making.
• Accountable for the timely closure of deviations, change control and qualification 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).
• 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/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
• 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.
• 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.
• Willing to travel 25% of the time to Malaysia office

Job Position

Production Planner

Reports to

Materials Manager

Job Description

• Create and release production orders and ensure on-time closing of production orders under SAP
• Drive and communicate the plans to materials planner
• Oversee preparation and timely release of raw materials from materials planner to production to meet production orders. Track usage of raw materials to production and report abnormality
• Work closely with cross departments to update demand forecast (e.g. hospital ops, production team, process development team)
• Review and control the production progress, follow-up with relevant departments to eliminate delays by expediting material shipments
• Interact with the lab management on a daily basis to resolve issues regarding production plan execution, ensuring that the daily production requirements are achieved and control the daily production plan and setup meeting as required
• Identify, negotiate and drive resolution of any conflicts to production plan with different departments (e.g. material availability, lab schedule changes, production abnormality)
• Prepare weekly ops report on the performance of production and highlight issues and bottlenecks that may potentially impact the achievement of the production schedule, materials planning, finance
• Support the analysis, development and implementation of new planning best practices
• Perform any other assigned projects

Requirements

• Bachelor’s degree in supply chain, logistic or industry management preferred
• 1-3 years in relevant position or experienced in material, supply or production planning will have added advantage
• Experienced in using excel and SAP is preferable
• Experience in working in GMP manufacturing environment
• Meticulous with a strong business acumen and customer satisfaction focus
• Excellent communication skills: written and verbal in English language
• Work independently and self-motivated

Job Position
Manager, Regulatory Affairs

Reports to
Director, Regulatory Affairs

Job Description

This position will be responsible for the following areas:

Regulatory Support:  Manages the preparation of regulatory applications associated with the company’s clinical trials for a variety of therapeutic areas and submissions to regulatory authorities.

Project Management:  Co-ordinates, prioritizes and tracks regulatory deliverables and submissions associated with the company’s clinical trials for a variety of therapeutic areas.

Position Responsibilities:

• Manage the preparation of applications and subsequent regulatory documents, in accordance with agreed timeframes.
• Provide regulatory support to other departments.
• Identifies and documents all regulatory project deliverables from each functional area by project for global regulatory submissions.
• Determine risk assessment and implement regulatory strategies for products in pre and post-approval stages.
• Works closely with the regulatory team and project team to identify and mitigate risks to meeting regulatory submission goals, address any delays and escalates when necessary.
• Helps facilitate product specific regulatory meetings and functional sub-teams by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines etc.
• Maintain current knowledge of global regulatory environment. Summarize, analyze and communicate regulatory intelligence and the potential impact.
• Develop and maintain a positive working rapport with the regulatory agencies.
• Build long term effective relationships and open communication with cross functional teams to provide accurate information and timeframes.
• Prepare documents based on the Company’s required format.

Requirements

• Bachelor’s degree, preferably in a science related field.
• At least 5 years of relevant regulatory experience
• Demonstrated ability to work in a team environment to develop, implement and deliver on project goals.
• Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills
• Possess a “can do” attitude
• Operates effectively in a smaller company and works well across teams within a matrixed organization.
• Demonstrated ability to work in a team environment to develop, implement and deliver on project goals.
• Strong sense of ownership and accountabilities.
• Strong knowledge of Regulatory Agency regulations, guidelines, and/or specifications (e.g., Asia, FDA, ICH, etc) preferred
• Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.