Job Position

Executive, Procurement (Direct Spend)

Reports to

Senior Procurement Manager

Job Description

• Performs sourcing for direct spend categories in compliance with the company policy and standard procedures.
• Develops, plans and executes strategic regional sourcing within the categories assigned by maximising value and reducing the total cost of ownership while maintaining and/or improving service quality and vendor service levels.
• Collaborates cross-functionally with key stakeholders in identifying the business needs and scope of works.
• Resolves issues or escalations triggered by requestors and ensures that all business relationships within the area of responsibilities are protected by appropriate contractual documents.
• Designs, negotiates and executes business agreements and contracts, including the implementation of service level agreements with strategic suppliers.
• Supports and participates in supplier audits, investigations, complaints, change controls and cGMP systems monitoring and follows up on the implementation of corrective actions.
• Supports continuous improvement initiatives and/or any projects assigned.

Requirements

• Bachelor’s Degree with at least 3 years of relevant working experience in managing direct spend categories in the healthcare and/or pharmaceutical industry.
• Strong knowledge and understanding of cGMP requirements with prior start-up experience are desirable.
• Well-versed and prior experience in vendor management, contracts creation, negotiations and formulating of service level agreements.
• Excellent ability in problem-solving, prioritizing urgent tasks and handling detailed information.
• Able to oversee implementation of contractual documentation and collaborate positively with all levels in a cross-matrix environment.
• Possess good understanding of suppliers’ landscapes, resourceful and able to carry out sourcing and market research for regional locations.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Excellent analytical, interpersonal, verbal and written communication skills in English.
• Prior knowledge with SAP preferred.

Job Position

Senior / Executive, Procurement (Indirect Spend)

Reports to

Senior Procurement Manager

Job Description

• Performs sourcing for indirect spend categories in compliance with the company policy and standard procedures.
• Develops, plans and executes strategic regional sourcing within the categories assigned by maximising value and reducing the total cost of ownership while maintaining and/or improving service quality and vendor service levels.
• Collaborates cross-functionally with key stakeholders in identifying the business needs and scope of works.
• Resolves issues or escalations triggered by requestors and ensures that all business relationships within the area of responsibilities are protected by appropriate contractual documents.
• Designs, negotiates and executes business agreements and contracts, including the implementation of service level agreements with strategic suppliers.
• Supports and participates in supplier audits, investigations, complaints, change controls and cGMP systems monitoring and follows up on the implementation of corrective actions.
• Supports continuous improvement initiatives and/or any projects assigned.

Requirements

• Bachelor’s Degree with at least 3 years of relevant working experience in managing indirect spend categories in the healthcare and/or pharmaceutical industry.
• Strong knowledge and understanding of cGMP requirements and prior start-up experience is desirable.
• Well-versed and strong in contracts creation, negotiations and formulating of service level agreements.
• Excellent ability in problem-solving, prioritizing urgent tasks and handling detailed information.
• Able to oversee implementation of contractual documentation and collaborate positively with all levels in a cross-matrix environment.
• Possess good understanding of suppliers’ landscapes, resourceful and able to carry out sourcing and market research for regional locations.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Excellent analytical, interpersonal, verbal and written communication skills in English
• Prior Knowledge with SAP preferred

Job Position

Biostatistician / Statistical Programmer

Reports to

Head of Biostatistics

Summary

The Biostatistician / Statistical Programmer is responsible for providing high quality statistical and statistical programming expertise on assigned studies. As a key member of the clinical development team, the Biostatistician / Statistical Programmer will collaborate cross-functionally to ensure a high level of rigour is brought to the design of studies, and the analysis, reporting and interpretation of results. In addition to study-level work, the Biostatistician / Statistical Programmer will have the opportunity to contribute to non-study related projects where innovative statistical and programming solutions are needed to solve complex drug development problems.

Job Description

• Collaborate with the clinical team to design studies, write protocols, review case report forms, interpret results, write clinical study reports and external publications.
• Manage the oversight of CRO statisticians and statistical programming groups to develop high quality statistical analysis plans, specification documents, and CDISC-compliant statistical deliverables (SDTM & AdaM data sets, Tables, Listings, Figures).
• Apply extensive programming expertise in SAS and other analytical software to clinical trial applications, including simulations to evaluate different study designs.
• Work closely with data management and clinical research/clinical operations personnel to develop study-specific data capture activities and processes to ensure data integrity.
• Develop technically sound, highly innovative statistical solutions to complex analytical problems.

Requirements

• Master’s Degree or PhD in Statistics or a related discipline
• Minimum of 3 years’ experience performing clinical trial statistics or statistical programming
• Strong analytical skills and sound knowledge of theoretical and applied statistics
• Excellent data manipulation, analysis and reporting skills using SAS
• Working knowledge and ability to implement the latest CDISC SDTM and AdaM standards
• Curiosity to learn and find creative, fit-for-purpose solutions to drug development problems
• Excellent oral and written English communication skills
• Strong ability to collaborate effectively across functional groups
• Good organisational skills, sufficient to multi-task in a fast-paced environment
• Experience with oncology trials would be an advantage

Job Position
Senior Analyst / Analyst, Business System

Reports To
Director, Information Technology

Responsibilities

• Responsible
  • Manage projects to ensure timely completion of projects within the timeline and cost.
  • Define, design, and document business flows and processes on small to large projects.
  • Define and articulate business rules required for data accuracy and consistency.
  • Ensure data integrity is maintained at all time.
  • Ensure that systems conform to applicable regulatory requirements; understand and follow appropriate SDLC, quality validation processes and application processes.
  • Any other duties as assigned by supervisor

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

•  Maintain
  • Implement improvement to existing system to support the changing business requirement
  • Implement data integration between multiple enterprise systems along with future strategy towards enterprise integration platform
  • Execute established policies and procedures to ensure compliance with application development polices and standards

• Establish
  • Implement solutions through leveraging standard “out of the box” system functionalities to the greatest extent possible to enable our business partners to be effective, efficient and agile.
  • Implement technology solutions for data warehouse and reporting

• Communicate
  • Partner with business stakeholders to gather requirements to identify efficient technological solutions.
  • Disseminate information in a timely manner within the team and across functions or teams.

Requirements

• Bachelor’s degree or equivalent, in Computer Science, Engineering or any related field with at least 6-8 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, Strategy & Project Management

Reports To
Director, Strategy & Project Management

Responsibilities

• Provide project management for the Product Development (PD) function on all clinical pipeline programs. This includes the development of project plans, tracking of deliverables, timelines, resourcing, scheduling and budget
• Provide effective coordination within the PD group, and collaborate well with external functions
• Provide effective communication and accountability program lead of all PD projects, including the projects’ objectives, timelines and deliverables
• 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
• Apply project management best practices, or could be flexible and do what is necessary to ensure the successful initiation, planning, execution, control and close-out of projects
• Develop and maintain positive relationships with internal and external functional team members, in ensuring a positive working environment and alignment with Tessa strategic objectives

Requirements

• Bachelor’s degree or above in life science
• 3+ years’ experience in in all phases of Project Management, Initiation, Planning, Execution, Monitor/Control, and Closeout
• 3+ years’ experience in biological/ pharmaceutical drug development, especially in CMC and/or Development, Manufacturing Support, and Quality Control
• Strong team player, able to effectively work within and across teams
• Highly organized, ability to effectively manage timelines/ deliverable/ resources
• Strong interpersonal skills and verbal/ written communication; ability to distill complex information into simple and clear messages
• 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
• Prepared for some domestic and international travel as required

Job Position
Senior Manager / Manager, Good Clinical Practices

Reports To
Senior Director, Quality

Responsibilities

• Responsible for setting the requirements for GCP
• Supports training needs for clinical operations
• Maintains the health and performance of GCP System.
• Establishes performance matrix, monitor and propose continuous improvement initiatives that will ensure that the GCP System will meet the current standards, as well as monitoring industry best practice and regulatory trends. Partner with Training Manager to determine training requirements to achieve these objectives
• Communicates with CROs, clinical operations and hospital operations on GCO requirements
• Participate in audits and Quality Management Review
• Provides QA oversight to clinical operations
• Partners clinical operations in the selection, audit and oversight of CRO Supports

Requirements

• Master Degree/Degree in Science with at least 8 years of relevant working experience in QMS in the pharmaceutical/biotechnology/medical device industry and supports CRO and clinical trial activities.
• Experience in training in GCP is strongly preferred.
• Ability to communicate effectively
• Proficient in GCP and QMS concepts

Job Position
Senior Specialist / Specialist, Quality Control (Flow Cytometry)

Reports To
Associate Director, Quality Control

Responsibilities

• Establishes and performs in-house flow cytometric analysis for finished product release test
• Be actively involved in method development and validation in accordance with cGMP requirements and applicable regulatory guidelines.
• Responsible for the implementation of validated flow cytometric analysis and the establishment of associated workflow, standard operating procedures
• Establishes trend analysis of the test results on the finished products, stability of drug substances & products supporting product quality review exercise
• Establishes procedures for monitoring the performance and manage the life cycle of the assay ensuring they are in a state-of-control
• Serves as Subject Matter Expert for the flow cytometric analysis participating in technical transfer, assay development & qualification projects; response to related regulatory queries; investigations of deviations and out-of-specifications and other QMS related activities
• Be involved in technical training for junior team members and other departmental projects as assigned by superior

Requirements

• Bachelor’s or higher degree holder in Biology/Biochemistry/Biotechnology/Bioengineering or equivalent with at least 5 years of working experience in technical position in biopharmaceutical industry and cGMP environment.
• Hand-on experience and in-depth knowledge in flow cytometry are required
• Understanding of USFDA & ICH guidelines for method qualification and/or validation is advantageous
• Able to work with people from different background and levels
• Prior experience in the following areas are preferred:
  • QMS and cGMP
  • Statistical process control (SPC)
  • Statistical analysis
  • Risk assessment (for example, FMEA)
• 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

Job Position
Senior Executive, Master Data Management

Reports To
Director, Supply Chain

Responsibilities

• Primarily responsible for the global creation, maintenance, governance and support of Vendor and Item Master Data in the Enterprise Resource Planning (ERP) system; collaborating with cross-functional business and IT stakeholders at all Tessa locations to sustain the ongoing data quality/accuracy/completeness of Master Data.
• Manage the overall process and governance of master data creation and maintenance to ensure consistency across the organization for all Vendor and Item Master Data.
• Develop processes and procedures to facilitate the compilation, review and approval of master data, along with written instructions, user references and special formatted forms and templates, to aid business users with defining their data requirements, and to enhance data quality and consistency.
• Manage governance of change requests to Master Data Management (MDM) components and policies. Review Vendor and Item Master Data requests to ensure high quality data is available to execute Global Procure-To-Pay business processes within ERP and other downstream applications.
• Lead cross-functional efforts to implement initial data set-up or mass data creation, revision or enhancement, as necessary to deploy new functionality or business process, to comply and better align with evolving data standards, policies or guidelines.
• Serve as the main liaison between the MDM team and the business and is the principal voice for data quality, integration and governance.
• Enforce established Master Data standards and best practices.
• Audit data quality of all master and reference data across all locations and coordinate resulting data cleansing activities.

Requirements

• Bachelor’s degree with at least 5 years of relevant working experience in the biotech and/or pharmaceutical industry.
• At least 2 years SAP ERP master data experience.
• High proficiency in Microsoft products (Word, Excel, PowerPoint).
• 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.
• Experience working with geographically diverse teams and remote employees is a plus.
• Collaborate well in cross-functional matrix environment, able to communicate and work independently with scientific/technical personnel.
• Good problem solving and troubleshooting skill.
• Excellent analytical, interpersonal, verbal and written communication skills in English.

Job Position
Senior Manager, Clinical Operations and Data Management

Reports To
Associate Director, Clinical Operations and Data Management

Position Summary 

This individual will lead the DM team, roll out appropriate processes and performance metrics to drive DM deliverables. This individual will work closely with the Clinical Trial team to provide direction and oversight for Clinical Data Management (CDM) deliverables.  This Individual will liaise with Contract Research Organizations (CROs) and/or external vendors in all aspects of data management for assigned trial(s).

Responsibilities

• Develop internal CDM guidelines and quality processes to ensure final databases are accurate.
• Set DM objectives to align with company’s needs and directives.
• Set Key Performance Indicators and drive performance within the department
• Provide oversight and participate in study set-up and initiation procedures such as CRF design, database design, edit check design/review, and DMP (data management plan) review
• Perform review of clinical trial protocols, with focus on potential CDM issues and cross-study data consistency
• Oversee all CDM activities performed by CROs, from study start-up, through database lock
• Ensures the proper collection, management, and storage of clinical trial data (according to regulatory requirements)
• Manage the incorporation of external datasets and final production of datasets for regulatory submission
• Perform data validation and quality checks, and initiate corrective and preventive actions as indicated
• Summarize data to reflect progress of clinical trial(s) and quality of data and sites on periodic and as required
• Participate in other activities and meetings to support the Clinical Trial Team as needed
• Represent CDM and effectively communicate requirements, strategy, timelines, and deliverables at internal cross functional team meetings and meeting with external vendors
• Provide mentorship and coaching to the team members.

Requirements

• Master’s/Bachelor degree in scientific, biological, statistical, computer science, or related field
• At least 10 years of clinical trial data management experience
• Working knowledge of Electronic Data Capture and other trial-associated database systems
• Proficiency with Microsoft Office (Excel, Word, Outlook, Power Point)
• Experience in Industry-sponsored Oncology trials an added advantage