Job Position
Senior Manager / Manager, Business Applications

Reports To
Director, Information Technology

 Job Description

• Responsible
  • Functional ownership and responsibility of various business applications within the company, mainly ERP, QMS, LIMS, Document Management System, Learning Management System, Manufacturing Execution System, Equipment calibration and maintenance etc
  • Oversee development of business process requirements, including working with application vendors and partners to define project scope and deliverables to support business objectives for APAC and US Operations
  • Work closely with Quality Computer System Validation, Regulatory and internal audit teams to achieve compliant and validated state of business applications
  • Lead the evaluation vendor solutions, develop alternatives and recommend technical solutions in meeting the needs of the business
  • Partner with software vendors, implementation partners, integrators and SaaS solution providers for the end to end business solutions delivery
  • Lead and manage a team of analysts, functional experts and solution architects to identify and deliver business capabilities through technology solutions
  • Undertake any other activities as required by the company

•  Support
  • Day to day operational user support including APAC and US operations

• Maintain
  • Improvement of existing system to support the changing business requirement
  • Improve design, configure and implement data integration between multiple enterprise systems along with future strategy towards enterprise integration platform

• Establish
  • Leverage standard “out of the box” system functionalities to the greatest extent possible while delivering solutions that enable our business partners to be effective, efficient and agile
  • Understand short term and long term data analytics and reporting requirements and implement technology solutions for data warehouse and reporting
  • Establish policies and procedures, ensure compliance with application development policies and standards

• Communicate
  • Partner with business stakeholders to identify technology capabilities to meet their strategic business roadmap and develop the application master plan
  • Collaborate with supply chain, Manufacturing, Finance, Commercial and other business functions to understand their IT needs and identify the “best fit” technology solutions to enable business capabilities
  • Provide status updates, ensure overall project quality and timeliness of project deliverables

• Participate
  • Participate in project application evaluation and development and identify potential risks, scope, cost
  • Participate in and contribute effectively to departmental planning and strategy processes

Requirements

• Degree in Computer Science/ IT or Engineering or any related field with at least 8 years of relevant working experience
• Prior experience in an GxP-related environment in a Biotech or Pharmaceutical company with computer system validation experience
• Experience in developing design functional specifications, test scripts, computer system validation and training documents
• Experience with SAP, TrackWise, LIMS, MES, EMS, QMS etc.
• Possess “can do” attitude to solve problems and take initiative to find opportunities for continuous improvement
• Process-oriented with an ability to think strategically to reach a sound decision
• Self-motivated and positive with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills
• Excellent interpersonal, verbal and written communication and presentation skills and ability to interact and interface with all levels of business including senior leadership team
• Comfortable in a fast-paced environment with minimal direction, but also able to follow the processes and policies of large corporations

Job Position
Senior Manager / Manager, Infrastructure and System

Reports To
Director, Information Technology

 Job Description

• Responsible
  • Plan, implement, manage and control all aspects of Information Technology Infrastructure to meet organizations and global of the group IT’s requirements including Telecommunications Facilities, IT Network and Systems to support APAC and US operations
  • Manage IT vendors to ensure operations of IT Infrastructure, Servers as well as Service Desk & Operations are delivered within the SLA
  • Develop Disaster Recovery/ Business Continuity
  • Protect and defend the Company from Cyber threats and prevent any security incidents Drive security awareness programs within the company
  • Perform internal security reviews and risk assessment
  • Involve in project management for IT related projects
  • Undertake any other activities as required by company

• Support
  • Onboarding and off boarding of employees
  • Act in alignment with users’ needs and system functionality to contribute to organizational policy manage system upgrades and security reviews
  • Manage day to day IT Support to all entities of the company including APAC and US operations

• Maintain
  • Network equipment, switches, firewall, servers, phones or other systems under IT and follow-up with vendors on issues
  • Tracking of IT assets and equipment, review purchase of IT related equipment and ensure that they are aligned to the company standard and direction
  • Ensure network and system are available 24×7
  • Ensure the system and processes are in accordance with information security and to be able to govern the IT activities ensuring the reliability of Network and system

• Establish
  • Design, develop and implement IT system and processes and procedures
  • Define backup and restore requirement for the company
  • Define security framework based on the company needs

• Communicate
  • Educate and train users and being the consultant for computer problem beyond the knowledge of technical staff
  • Ensure employee adhere to company IT policies and procedures

• Participate
  • Handle annual budgets, reviewing quarterly expenses and ensure cost effectiveness related to IT infrastructure, servers and end user computing
  • Define the company IT policies and provide security advisory and oversight

Requirements

• Degree in Computer Science/ Engineering or any related field with at least 8 years of relevant working experience in manufacturing environment
• Working experience in pharmaceutical environment is a plus
• Experience in network equipment, network links (internet, LAN, WAN), wireless solution, UC, VC and network security
• Experience in servers in Windows environment and Service Desk
• Experience in delivering, managing and implementing multiple stream of projects and vendors to ensure successful delivery of projects
• Good technical knowledge if managed network appliances, LAN/WAN, routing technologies, switches, VLAN, access control list, SNMP, IP Networking, wireless, UC, VOIP and security products
• Possess leadership, problem-solving and planning and organisation skills
• Self-motivated with a strong drive towards fulfilling accomplishments
• Good team player and possess strong sense of Integrity
• Knowledge of technology solutions especially with Microsoft Technology will be an advantage
• ITIL foundation, CCNA, MCSE, CISSP certification are added advantage
• Occasion travelling is required

Job Position
Senior Manager/Manager, Business Development

Reports To
Chief Business Officer

Responsibilities

• Search and evaluate new opportunities for business growth that are aligned with Tessa’s corporate strategy.
• Co-ordinate due diligence efforts for specified opportunities and ensure targets meet Tessa’s strategic and financial requirements.
• Build financial models and present evaluation of potential business areas and/or specific opportunities.
• As directed by CBO, participate in, and in some cases, manage interactions with third party advisors.
• Act as a key contributor in the development of materials needed for negotiations and the finalization of contracts.
• Lead or be a key team member on internal strategic projects that aim to define or refine Tessa’s strategy in critical growth areas.
• Play an important role in Tessa’s corporate strategic planning process.

Requirements

• Undergraduate degree in biological science, medical or related field required. Graduate degree preferred. MBA is highly desirable.
• Ideally 3 to 5 years of experience in corporate strategy, business development, strategy consulting, or investment banking in the pharmaceutical/biotechnology sector. International experience desirable
• Excellent written and verbal communication skills.
• Strong analytical and financial modeling capabilities
• Financial and business acumen
• Ability to conduct high quality research on potential target companies, sectors and new business areas, and drive to recommendations
• Demonstrated understanding of how business development/corporate strategy drives company value
• Tolerance of ambiguity and the ability to adapt quickly and flexibly to changing role requirements
• Ability to digest and interpret complex data and situations
• Ability to both lead and be a productive member of multi-functional teams
• Ability to understand the “big picture” and to define and tell a strategic story
• Resourceful, creative and innovative

Job Position
Senior Specialist, Clinical Applications

Job Description

• Oversee product related operations conducted by clinical trial sites to ensure products are properly administered during bedside application (subject visits scheduling, immunotherapy clinical workflow, infusion logistics etc.)
• Provide site qualification, training and evaluation at trial sites within US to ensure Tessa’s products are delivered efficiently to patients.
• A subject matter expert representing end users and collaborate with internal stakeholders to enhance understanding of the product portfolio and user experience.
• Independently support and troubleshoot immunotherapy related issues and escalations
• Oversee inventory and management of Infusion related equipment and ancillaries provided to all sites including sourcing, assembly and distribution of items.
• Review, update and manage protocol and Instruction manuals periodically to ensure smooth flow of trial operations
• Timely Maintenance of study related documents for all activities undertaken

Requirements

• Bachelor degree in Biomedical Sciences or any related field with at least 5 years of relevant working experience in the biotechnology / pharmaceutical or clinical research industry.
• Site Experience / Nursing Background is advantageous
• Proficient in Microsoft office such as Microsoft Power Point and Excel.
• Candidates from New Jersey / East Coast is preferred
• Able to work independently and remotely, Global experience is preferred.
• Possess an analytical mind, meticulous, and organized in his/her work.
• Possess good problem-solving skills and able to think logically under pressure.
• Good communication skill and able deliver effective training
• Travel up to 50% is required

Job Position
Senior Scientist, Product Development

 Job Description

The position will be based in Singapore and report to the Director of Product Development.  This candidate will be responsible for daily scientific experiments, data analysis as well as technology transfers across functional laboratories for cell therapy processes in alignment to project timelines and strategies for Product Development.

Responsibilities

• Learn and master the production processes and related in-house analytical methods in both scientific knowledge and hands-on skills for VST cell therapies
• Perform GMP production of VST cell therapies to support clinical trial materials for early phase clinical studies
• Develop and optimize flow cytometry assays, immunoassay techniques (ELISAs, Luminex) and cell-based assays, (ELIspot, bioassays, etc.)
• Independently design, plan, execute and analyze data from in vitro studies to assess immunological function and operate, for immune phenotyping, flow-cytometers such LSR Fortessa II and cell sorting on BD FAS Aria II/III
• Design protocols for optimizing and sorting of parameters along with verification of sorting purities/efficiencies.
• Establish and validate work-stream for isolating subsets of immune cells from various immune organs by flow cytometry
• Identify critical parameters and reagents as well as acceptable operational ranges of the production processes
• Identify critical quality attributes of the process intermediates and final products, and if needed, perform analytic work for these attributes
• Perform training and technology transfer across laboratories and sites for cell therapy processes, including assistance in setting up a new pilot plant for supporting early clinical studies
• Author reports to document development efforts for cell therapy production and quality control
• Support regulatory affairs’ filing in the product development area by providing key information and reviewing submissions
• Lead the effort in providing trend analysis of manufacturing processes after technology transfer, work with the production team for trouble shooting efforts, and advice in preventative actions to ensure long-term production success
• Ensure laboratory housekeeping, maintenance of equipment, and inventories of reagents and consumables
• Mentoring of junior scientists

Requirements

• PhD in Immunology or Life Sciences with at least 5 years of experience working in GxP environment
• Extensive research development experience in immunology and/or molecular biology and/or Virology.
• Strong understanding of immune system function and dysregulation, experience with various immune cell isolation techniques, including cell sorting
• Proficiency with FlowJo, FACSDiva software and statistical tools for data analysis
• Experience with ELISPOT and other readouts of antigen-specific immune responses
• Strong analytical skills and good scientific writing and presentation skills.
• Good working attitude and willingness to learn
• Good problem-solving and communication skills
• Highly self-motivated and a good team player  

Job Position
Manager, Product Development

 Job Description

The position will be based in Tessa’s US Office in Houston, Texas, and is responsible for managing technical progress of the research projects, clinical trial material supply, and monitors GMP production for supporting clinical trials in collaboration with Baylor College of Medicine and other US entities.  This position communicates the operational detail and align the timeline and strategy with Tessa headquarters in Singapore.

Responsibilities

• Serve as a liaison for the Product Development department with Baylor College of Medicine
• Collect research and GMP production data and perform data analysis for trending analysis and development history record, and build a database for future technology transfer back to Singapore headquarter or to CMO
• Provide efficient communication on technical aspects of Baylor collaboration projects, using analyzed GMP and CMC technical data to clearly illustrate key messages
• Assist in project management and logistic support for scientific and technical aspects of Baylor collaboration projects, from planning, budget, following up contracts, tracking progress, and timeline.
• Support other US product development projects (e.g., contract research organizations, contract manufacturers, service/supply vendors).
• Ensure all communications with SG headquarters is effective and transparent, specifically follow-up of ongoing issues, timely updates on GMP production for trials, data collection and tech transfers
• Collaborate with QA and regulatory affairs departments to ensure GMP data quality and timely records retrieval in accordance to Tessa’s Quality Policies
• Expected to flag potential quality problems and communicate any deviations and escalate issues as appropriate
• Develop and maintain positive relationships with collaboration partners ensuring team environment and alignment with Tessa strategic planning
• Procure critical materials for scientists in Baylor for clinical trials, process optimization, and analytical development
• Participate in future hiring of this US operation

Requirements

• Bachelor or Master degree in life science or in business with sufficient course work in life science
• Data analysis skills using basic statistics are required
• Minimum 5 years of proven successful track record in life science industry or GMP/GLP regulated laboratories and basic knowledge of GMP, GCP, and CMC & QA guidelines
• Experience in pharmaceutical drug development, especially in supporting clinical trials, is highly desirable
• Highly developed inter-personal skills and verbal/written communication
• Strong problem solving and critical thinking skills
• Ability to manage situations and motivate colleagues through objective and insightful leadership

Job Position
Specialist, Product Development

 Job Description

This position is located in Tessa’s Singapore Office.  He or She is responsible for managing technology transfers, serves as a technical expert for blood process and equipment troubleshooting and Point of Contact for satellite laboratories. This position communicates operational, logistical detail and manages the timeline and ensures adherence to the strategy plan with satellite laboratories in collaboration with Tessa’s departments in Singapore.

Responsibilities

• Serve as a technical point of contact for the Product Development department with satellite laboratories
• Collaborate with various departments to strategize, plan and execute technology transfer of processes between satellite labs
• Work closely with vendors to troubleshoot any blood handling process and equipment issues and seek resolution within reasonable timeframe
• Support management of CMOs for Product Development team and major stakeholders of Tessa’s departments
• Assist in project management and logistic support for scientific and technical aspects of CMOs, Satellite laboratories from planning, budget, following up contracts, tracking progress, and timeline
• Support other product development projects (e.g., contract research organizations, contract manufacturers, service/supply vendors)
• Develop and maintain positive relationships with collaboration partners ensuring team environment and alignment with Tessa strategic planning

Requirements

• Bachelor degree in life science or Engineering fields
• 2-3+ years proven successful track record in life science industry or GMP/GLP regulated laboratories and basic knowledge of GLP, GCP, and CMC & QA guidelines
• Technology transfer and/or early clinical stage program experience is a must
• Experience in pharmaceutical drug development, especially in supporting clinical trials, is highly desirable
• Prior experience with PBMC isolation or Sepax instrument desired
• Highly developed inter-personal skills and verbal/written communication
• Strong problem solving and critical thinking skills
• Ability to manage situations and motivate teams through objective and insightful leadership
• Traveling up to 15% may be required
• Multi language skills for the APAC area desired

Job Position
Scientist, Product Development

 Job Description

The position will be based in Singapore and report to the Director of Product Development. The candidate will be responsible for daily scientific operations, as well technology transfers across functional laboratories for cell therapy processes in alignment with project timelines and strategies.

Responsibilities

• Learn and master diverse product development processes and related in-house analytical methods for both scientific knowledge and hands-on skills for VST cell therapies
• Perform GMP production of VST cell therapies to support early phase clinical studies
• Identify critical parameters and reagents, as well as acceptable operational ranges for production processes
• Design and conduct experiments for robustness, gap analysis, range finding, optimization and troubleshooting of the production processes
• Identify critical quality attributes of process intermediates and final products, and if required, perform analytic work for these attributes
• Perform training and technology transfer across laboratories and sites for cell therapy processes, including assistance in setting up a new pilot plant to support early phase clinical studies
• Lead efforts to provide trend analysis for various manufacturing processes after technology transfer. Work with the production team to troubleshoot and take preventative actions to ensure long-term production realization
• Maintain good laboratory housekeeping, maintenance of equipment, and inventory of reagents and consumables

Requirements

• BSc/MSc in Immunology or Life Sciences with at least 5 years of experience working in an GxP environment
• In-depth research development experience in the fields of immunology and/or molecular biology and/or Virology.
• Strong analytical, scientific writing and presentation skills.
• Basic statistical knowledge or process engineering experience is highly desirable
• Good working attitude and willingness to learn
• Good problem-solving and communication skills
• Highly self-motivated and an excellent team player