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
Engineer, Environmental, Health, Safety & Security (EHS&S)

Reports to
Manager, Facilities & Engineering

 Job Description

• Responsible for ensuring Tessa’s current Technical Operations Hub is maintained in good operational state.
  • This includes Environmental, Health, Safety and Security.
  • Scope of operations may include provide EHS&S Training and Promotion, setting up ERT, ERP and Safety Committee.
• Manage external contractors in the areas of Fire Protection, CCTV and Card Access.
• Work closely with Building Owner to ensure a seamless interface between internal and external EHS&S.
• Ensure maintenance and service contracts are executed as per requirements; establish regular review points with external contractors as required to continually improve processes and performance.
• Work cross functionally to ensure Customers’ operations are meeting EHS&S policy and requirement.
• Ensure the execution of service and maintenance contracts are properly documented.
  • Where Singapore Statutory requirements apply, ensure requirements are met.
• Evaluate EHS&S service and maintenance contracts and revise if necessary.
• Support facility improvement projects or design projects as required.

Requirements

• Diploma or Degree in EHS Engineering.
• At least 2 years of relevant experience in EHS&S
• Willing to learn and continuously improve.
• Self-Starter with good initiative to work independently.
• Good communication and interpersonal skills.
• Knowledge in MOM, NEA, SCDF and SPF is an added advantage.
• Comply to Tessa safety practices and standard operating procedures.
• Exhibit and promote Tessa’s Core Values.

Job Position
Engineer, Facilities

Reports to
Manager, Facilities & Engineering

 Job Description

• Responsible for ensuring Tessa’s current Technical Operations Equipment and Rooms are maintained in good operational state.
  • This includes general facility area/room serviceability, serviceability of fire prevention, security access control, HVAC, electrical, water and gas systems.
  • Scope of operations may include a cGMP manufacturing facility.
• Manage external contractors in the areas of cleaning, waste removal and pest control.
• Work closely with Building Owner to ensure a seamless interface between internal and external facilities and utilities.
• Ensure maintenance and service contracts are executed as per requirements; establish regular review points with external contractors as required to continually improve processes and performance.
• Work cross functionally to ensure facility and utilities meet Internal Customers’ needs.
• Ensure the execution of facilities service and maintenance contracts are properly documented.
  • Where cGMP requirements apply, ensure requirements meet GDP and internal Quality standards
• Evaluate facilities service and maintenance contracts and revise if necessary.
• Support facility improvement projects or design projects as required.
• Be an active member of the Safety Committee.

Requirements

• Diploma or Degree in Facilities, Mechanical or Electrical Engineering.
• At least 4 years of relevant experience in managing contractors in facility maintenance and cGMP facility operations.
• Experience in cGMP requirements for cleanroom operations, pest control and cleaning will be advantageous.
• Willing to learn and continuously improve.
• Self-Starter with good initiative to work independently.
• Good communication and interpersonal skills.
• Knowledge in cGMP or Bio-Pharma R&D is an added advantage.
• Comply to Tessa safety practices and standard operating procedures.
• Exhibit and promote Tessa’s Core Values.

Job Position
Engineer, Calibration & Maintenance

Reports to
Manager, Facilities & Engineering

 Job Description

• Responsible for ensuring Tessa’s current Technical Operations Equipment and Rooms are maintained in good operational state.
  • This includes all Equipment and Rooms from all Internal Customers
  • Scope of operations may include EMS, CMMS, C&M SOPs and Documentation
• Manage external contractors in the areas of System, Equipment and Rooms for Calibration and Maintenance.
• Ensure maintenance and service contracts are executed as per requirements; establish regular review points with external contractors as required to continually improve processes and performance.
• Work cross functionally to ensure Systems, Equipment and Rooms meet Internal Customers’ needs.
• Ensure the execution of Calibration and Maintenance contracts are properly documented.
  • Where cGMP requirements apply, ensure requirements meet GDP and internal Quality standards
• Evaluate C&M service and maintenance contracts and revise if necessary.
• Support facility improvement projects or design projects as required.

Requirements

• Diploma or Degree in Mechanical or Electrical Engineering.
• At least 4 years of relevant experience in managing contractors in cGMP facility operations.
• Experience in cGMP requirements for Calibration and Maintenance will be advantageous.
• Willing to learn and continuously improve.
• Self-Starter with good initiative to work independently.
• Good communication and interpersonal skills.
• Knowledge in CSV, EMS, CMMS, cGMP or Bio-Pharma R&D is an added advantage.
• Comply to Tessa safety practices and standard operating procedures.
• Exhibit and promote Tessa’s Core Values.

Job Position

Associate Director, Strategy & Project Management

Reports to

Director, Strategy & Project Management

Job Description

• Provides strategic leadership and work with program/project lead to drive the product development strategy with the input from the program/project team, from pre-candidate selection to the late stage clinical projects/commercialisation.
• Develops and manages the execution of integrated cross- functional project plans, including scopes, resource plans, schedules and budgets, in line with Company’s strategic objectives and priorities.
• Establishes and implements project management systems and processes to proactively track project status across the different stages, identify and manage project dependencies and critical paths and ensure adherence to project timeline, resource plan and budget.
• Develops program/project level risk assessment and mitigation strategies; to proactively anticipate potential risks and impacts and to facilitate resolution of issues on a timely basis.
• Collaborate and provide effective coordination for cross-functional teams to ensure alignment of project objectives and support resolution of project issues
• Applies project management best practices in the development, initiation, planning, execution, control and close-out of projects.
• Prepares progress reports and key updates to the Senior Management on a regular basis or as required
• Alliance management of investigator initiated trials

Requirements

• B.S. degree in Life Sciences and MBA, MD, or PhD required.
• More than five years’ experience in the biotechnology or pharmaceutical industry
• At least Three years’ experience in managing clinical stage projects (immuno oncology/ trial experience is preferred).
• In-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs).
• Strong interpersonal skills in the areas of relationship building and communication
• Demonstrated experience in strategic planning and decision analysis.
• Has expertise in all phases of Project Management, Initiation, Planning, Execution, Monitor/Control, Closeout.
• Demonstrated experience in developing, managing and controlling cross functional project budgets, timelines and scope.
• Ability to prioritize and multitask to enhance productivity and manage workload in a fast-paced, rapidly changing environment.
• Demonstrates critical, creative thinking and problem-solving skills, and the ability to produce clear and concise written and verbal communication skills.

Job Position

Manager, Biobank and Logistics

Reports to

Director, Supply Chain

Job Description

• Manage the biobank and logistics operations across Tessa’s facilities globally.
• Establish shipment lanes for clinical projects, including planning, sourcing of couriers, import/export permitting, shipment qualification/validation, performance monitoring.
• Manage daily GMP biobank and shipment operational activities.
• Business process owner for cell therapy coordination system to manage the chain of custody of cell materials.
• Business process owner for sample management system.
• Maintain operational KPIs for biobank and shipment activities. Monitor and continuously improve biobank and shipment performance and service level.
• Develop risk assessment and mitigation plan for biobank and shipment, escalate business risks to proper level of management.
• Support Quality department in vendor audit, investigation, complaint, change control and GMP systems monitoring, and follow up on implementation of corrective actions.
• Continuous business process improvements (e.g., streamlining the biobank and logistics processes, development or revision of shipment procedures, documenting processes, risk assessment etc.).

Requirements

• Bachelor’s degree with at least 5 years of relevant working experience in the biotech and/or pharmaceutical industry.
• Well-versed in logistics and supply chain, biologic drug development, manufacturing, testing and release processes, or GMP material or service provider management.
• Proven experience in warehousing activities under GMP conditions, preferably in cryogenic storage environment.
• Strong knowledge of GMP, SOP and quality processes. Strong understanding of the Quality Assurance systems, quality audit, and supplier qualification program.
• Experience in ERP systems usage, SAP preferred.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Collaborate well in cross-functional matrix environment, able to communicate and work independently with scientific/technical personnel.
• Good people management, problem solving and troubleshooting skill.
• Excellent analytical, interpersonal, verbal and written communication skills in English.

Job Position
Senior Manager / Manager, Regulatory Affairs CMC

Reports To
Senior Director, Regulatory Affairs CMC

Location
United States

Job Description

Incumbent will be responsible for the following areas:

Project Management: Act as a Regulatory Project Manager in planning, coordination and tracking CMC dossier towards marketing registration biological licensing application. Interact with cross-functional departments for deliverables are met according to the company’s timelines.

Regulatory CMC Lead: Represent Regulatory Affairs CMC perspective to teams. Provide regulatory CMC guidance on FDA and global requirements to the team. Prepares and submit high quality regulatory submissions to the FDA and other health authorities in accordance with regulatory guidelines and applicable federal laws.

Position Responsibilities

Prepares CMC sections of regulatory submissions for cell and gene therapy products in various phases of product development life-cycle. Define CMC content (data and documentation) resulting in high quality submissions.

Responsible for regulatory CMC review of regulatory document, reports and data for conformance with the requirements and expectations of health authorities.

Serve as Regulatory Affairs CMC Project Manager, liaise with cross functional departments; strategize and plan for timely registration submissions in the Unites States and other countries assigned.

Work closely within the Regulatory department to prepare robust regulatory applications to achieve departmental and organizational objectives.

Serve as Regulatory Affairs CMC lead for assigned project in deliver high quality CMC dossier suitable for registration and subsequent post-approval CMC activities.

Compile, review and approve CMC documents/modules for assigned marketing registration applications accordingly to regulatory requirements. Coordinate response to information request as well.

Work with Tech Ops team in providing regulatory CMC requirements and resolve technical issues.

Prepare CMC briefing package for various agency meetings.

Interact with FDA under the guidance of department head.

Maintain relevant cell gene CMC knowledge base of existing and emerging regulations, standards, or guidance and provide interpretive assistance to cross-functional teams.

Requirements

Minimum of Bachelor’s degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Advanced Degree in Science desired.

5-7 years of related biologics (cell/gene therapy highly preferred) industry experience with a minimum of 3 years in Regulatory Affairs.

Demonstrated project management experience can work in a cross-functional team environment to develop, implement and deliver on project goals.

Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.

Proven ability to manage projects. Capable of performing independently and thinking analytically and creatively to solve problems.

Recent experience in preparing CMC sections of INDs/BLAs for cell and gene therapy products is required. International regulatory experience is a plus.

Be a team player can work across functions for achievement of shared goals in a small company setting.

Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally.

Successful track record in delivering regulatory projects.

Solid wording knowledge of CMC requirements for biologics in development towards marketing registration in the United States.

Understand drug product development progress.

Understanding of scientific principles and capable of interpreting regulatory requirements.

Job Position

Senior / Manager, Quality Assurance Validation

Reports to

Director, Quality

Job Description

Provide QA oversight for Qualification and Validation activities at Tessa Manufacturing site(s) with the following core responsibilities:

• Setup/be part of the QA validation team to support all aspects of qualification and validation program, including qualification & re-qualification of process and testing equipment, manufacturing process, QC testing, shipping, etc.
• Develop, review and approve validation and qualification strategies for manufacturing facility, processes, cleaning, shipping and equipment, including supporting risk assessments.
• Provide QA expertise to assess impacts and support investigations, deviations, CAPAs related to validation / engineering processes.
• Provide oversight for validation / engineering related cGMP documents including, but not limited to validation plans, SOPs, work instructions, templates, guidelines, protocols, summary reports and ensure consistency and compliance with regulatory requirements.
• Review and approve facility and equipment related change controls, including the assessment for equipment criticality, calibration / PM program.
• Create Validation Master Plan and ensuring that the Company’s Validation Master Plan is up to date, maintaining the validation life cycle of the manufacturing facility.
• Manage site validation documentation program, validation vendor management and maintenance.
• Provide leadership and guidance to staff on qualification / validation matters. Directs efforts to ensure efficient and effective systems are maintained and continuously improved.
• Participate in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective / preventive actions.
• Provide support as needed in the regulatory audits / inspections or meetings.
• Perform other ad-hoc duties as requested by manager / supervisor.

Requirements

• Degree and above in Cell biology/ Biotechnology/ Microbiology/Biomedical Science/ Biochemistry or Science related field with at least 5 years of hands-on experience in GMP-regulated cell therapy / biologic product manufacturing industries
• At least 3 years of experience in Quality Assurance and / or Compliance, including oversight for validation projects across the various validation activities from initial planning stage up to the eventual report summary stage.
• Extensive knowledge of cGMP requirements, with working knowledge and understanding of Validation, Production, Quality Control requirements and activities preferably in equipment / process validation, shipping validation, QC method validations, facility qualifications, etc.
• Strong working knowledge of US FDA and other equivalent regulatory requirements.
• Mastery and knowledge of quality principles and cGMP guidelines.
• Good understanding of validation principles and critical process parameters.
• Ability to identify problems, troubleshoot and complete or coordinate corrective actions.
• Strong planning and prioritization of activities for self without supervision.
• Ability to write & communicate effectively in a professional manner with peers, management and other functional groups.
• High attention to details, well organized and can effectively manage multiple projects.
• Good people management skills with ability to work cross-functionally.

Job Position

Manager, Supplier Quality Assurance

Reports to

Associate Director, Quality Assurance

Job Description

• Responsible for oversight of the company’s supplier quality program, including the selection, evaluation and performance monitoring of suppliers.
• Ensure highest quality and compliance of suppliers of incoming materials, and service providers engaged by the Company.
• Develop and lead the supplier qualification (and re-evaluation) program, ensuring full compliance to regulatory and company requirements.
• Support technical and end-user teams in the selection of potential suppliers as necessary.
• Monitor performance of suppliers; ensure investigations related to supplier quality issues or suppliers’ complaints are completed with assignable root cause(s) established and CAPAs implemented in a timely manner.
• Develop quality agreements with suppliers and ensure updates are made to them whenever applicable.
• Evaluate supplier change notifications and drive corresponding supplier change notification review by functional areas until change implementation is completed.
• Review and maintain the Approved Supplier List including supplier qualification status and the corresponding material specifications.
• Plan Annual Audit Schedule for Suppliers and ensure such audits are performed as per plan and subsequently reported on the audit outcome. Ensure timely completion and update all CAPAs resulting from supplier audits.
• Perform other ad-hoc duties as requested by manager / supervisor.

Requirements

• Degree and above in Cell biology/ Biotechnology/ Microbiology/Biomedical Science/ Biochemistry or Science related field with at least 3 years of hands-on experience in regulated pharmaceutical industries and / or regulatory agencies.
• Minimum 2 years in supplier quality management.
• Good understanding of quality management principles; minimum of 2years in leading quality audits (preferably 3^rd party and / or 2^nd party) with ASQ Certified Quality Auditor (CQA) or other equivalent international certification desirable.
• Strong working knowledge of US FDA and other equivalent regulatory requirements as well as industry quality management tools, standards and quality systems.
• Broad pharmaceutical experience is preferred with working knowledge and understanding of production, Quality Control and Validation requirements and activities.
• Able to identify problems, troubleshoot and complete or coordinate corrective actions.
• Strong planning and prioritization of activities for self and team without supervision.
• Ability to communicate (both verbally and written) effectively in professional manner with peers and management.
• Excellent interpersonal and leadership skills, ability to work cross-functionally
• High attention to details, well organized and effectively manage multiple projects.
• Good people management skills.
• Able to travel at least 20% of the time.

Job Position

Senior/Quality Operations Executive

Reports to

Senior Manager, Quality Operations

Job Description

This role is responsible for the execution of daily quality operation activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility. Area of responsibilities include, but not limited to:

• Provide quality oversight to ensure manufacture of cell therapy products is in compliance with Company procedures and cGMP regulations.
• Review of completed batch records to ensure compliance with GMP per written procedures
• Support establishment of and review and/or approve Master Batch Records
• Review and/or approval of GMP relevant documents not limited to SOPs, work instructions, protocols, summary reports
• Support and prepare batch documentation for lot disposition
• Review/approve manufacturing-related quality issues and investigations (e.g. deviations, trends, Out-of-Specification), to ensure their proper and timely completion, including that of the corresponding corrective and preventive actions (CAPA); and monitor effectiveness of implemented CAPAs
• Assess temporary and permanent changes from the manufacturing process and their impact on quality and regulatory compliance
• Provide guidance to the junior team member and conduct training
• Quality inspection of the cleanroom/manufacturing processes and provide on the floor QA support
• Participate in process improvement projects and proactively seek to improve and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times
• Support risk assessment activities
• Support Annual product quality review
• Perform other ad-hoc quality duties as requested by manager

Requirements

• Degree and above in Cell biology/ Biotechnology/ Microbiology/Biomedical Science/ Biochemistry, Chemical Engineering, or Science related field.
• At least 3 years of working experience in quality assurance and/or compliance is preferred or with hands-on experience in cell therapy / Biologic product manufacturing GMP-regulated industries.
• cGMP experience with good working knowledge and understanding of biopharmaceutical manufacturing activities and regulations
• Change control experience and deviation is preferred
• Good understanding of quality management principles
• High attention to details
• Well organized and effectively manage multiple project
• Ability to identify problems, troubleshoot and complete or coordinate corrective actions
• Ability to communicate (both orally and written) effectively in professional manner with peers and management
• Good interpersonal and able to work with cross functional team collaboratively
• A positive attitude and an ability to adapt to, and embrace changed conditions
• Frequent travelling with at least 70% of the time to be based in Malaysia site
• For Senior role, change control and deviation experience is required