Vela Research Singapore Pte Ltd 

Vela is a recently incorporated Molecular in vitro Diagnostics Company with Research and Development facilities in Singapore and the United States. Vela Diagnostics is focused on the development and commercial distribution of IVD molecular tests in the field of Oncology, Pharmacogenetics, Microbiology and Infectious Diseases. Vela’s Management team consists of industry veterans.

Reports to: Director of Microbiology

Responsibilities:

• Develop innovative Next Generation Sequencing (NGS) based in vitro Diagnostic products in fast-paced product development environment
• Design, implement, analyze and present experiments to evaluate existing and new methods for product development and identify creative solutions to overcome current limitations
• Conduct clear and concise communication of R&D results through oral updates, written reports and technical meetings
• Support set-up, operation and expansion of R&D facility in Singapore
• Assist to establish and follow procedures that meet FDA QSR and ISO 13485 requirements
• Take full accountability of timelines for development of assigned products / projects.
• Work closely with Head of Regulatory

Requirements :

• PhD or Master in the biological sciences, medicine or related field
• Not less than 3 years of industrial experience with a minimum of 2 years in commercial product development, preferably in the molecular diagnostics domain, or more than 3 years experience in a molecular service laboratory
• Proven track record of successful assay or product development
• Strong background in molecular biology, genetics, genomics and a sound understanding of genetic assay development
• Experience with next-generation sequencing
• Working knowledge of ISO13485 and QSR guidelines desired
• Able to work independently and as part of a team
• Ability to prioritize and meet deadlines           
• Good communication, organization, interpersonal skills
• High level of integrity and reliability
• Knowledge of MAC OS and Microsoft office applications

Contact: Human.Resources@veladx.com

Vela Operations Singapore Pte Ltd

 Field Service Engineer, Singapore

Vela is a recently incorporated Molecular in vitro Diagnostics Company with Research and Development facilities in Singapore and the United States. Vela Diagnostics is focused on the development and commercial distribution of IVD molecular tests in the field of Oncology, Pharmacogenetics, Microbiology and Infectious Diseases. Vela’s Management team consists of industry veterans.

Reports to: Director, Global Service & Support

Responsibilities:

• Provide routine technical support to customers on operational and maintenance aspects of system equipment and perform on-site service, repair and/or installation of company product(s).  This may include any aspect of field support and is not limited to mechanical/system hardware and software or networking/wireless networking
• Using established practices, policies and procedures, you will use your troubleshooting skills diagnosing mechanical, hardware, software and system issues and determine the most cost effective repair/resolution to minimize customers downtime.
• Provide analysis, feedback and recommendations on the performance of the product and document all activities in accordance with the company’s quality procedures.
• Utilize data collection from customers to improve the quality and cost of the product through a proactive program that includes interaction with internal network.
• Adhere to all environmental, health and safety SOPs, equipment, policies and procedures, including any department specific requirements. 

Requirements:

• Degree in Electronics Technology, Electrical Engineering or relevant discipline at an accredited college or university. Additional knowledge in Information Technology or Medical Technology will be an advantage.
• Not less than 2 years of working experience in repairing or servicing mechanical / system hardware and software or networking / wireless networking.
• Able to develop in-depth technical related trouble shooting skills and exercise sound judgment and make decisions based on accurate and timely analyses.
• Must be prepared to work after office hours; provide support during weekends and public holidays on a rotating basis and be on call 24/7 during rotation.
• Good written and verbal communication, interpersonal and team skills. 
• Effective customer service skills, which include a positive and proactive attitude and ability to build and maintain good rapport with the customers.
• High level of integrity and dependability with a strong sense of urgency and results driven.
• Knowledge of basic chemistry.
• Singaporean preferred as this position is required to travel overseas as and when required / on call basis.

Contact: Human.Resources@veladx.com

Vela Operations Singapore Pte Ltd 

Quality Assurance Specialist, Singapore

Vela is a recently incorporated Molecular in vitro Diagnostics Company with Research and Development facilities in Singapore and the United States. Vela Diagnostics is focused on the development and commercial distribution of IVD molecular tests in the field of Oncology, Pharmacogenetics, Microbiology and Infectious Diseases. Vela’s Management team consists of industry veterans. 

Reports to: Manager, Quality Systems 

Responsibilities:

• A representative for all design control projects, ensuring that all required documents for each phase of the design process have been finalized and approved prior to moving to the next design phase.
• Guiding and mentoring the R&D team in the usage of design control templates and ensure compliance to good documentation practices.
• Review, implement and recommend improvements to the design control process and document control function.
• Subject matter expert on relevant guidance documents from regulatory authorities related to development studies.
• Ensure compliance to the quality system within R&D
• Design control representative for internal audits and external audits by regulatory bodies.
  • Maintain daily operation with regards to the quality aspect of the organization.
  • Provide support to the QA/RA in other duties

Requirements:

• Not less than 3 years of quality system experience in a medical device company.
• Bachelor degree in Science/Engineering or relevant degree at an accredited college or university.
• Possess biological science background or working experience in a laboratory environment will be an advantage.
• Direct and hands-on experience in design control project and/or quality system operations in a dynamic multi-national environment.
• Qualified Internal auditor for ISO 13485.
• Good interpersonal and team skills, ability to communicate and manage well at all levels of the organization.
• Strong problem solving and creative skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
• High level of integrity and dependability with a strong sense of urgency and results driven.
• Able to write and communicate in English fluently. 

Contact: Human.Resources@veladx.com

Vela Operations Pte. Ltd.

Manufacturing Specialist, Singapore

Vela is a recently incorporated Molecular in vitro Diagnostics Company with Research and Development facilities in Singapore and the United States. Vela Diagnostics is focused on the development and commercial distribution of IVD molecular tests in the field of Oncology, Pharmacogenetics, Microbiology and Infectious Diseases. Vela’s Management team consists of industry veterans.

Reports To:  Production Manager

Roles and responsibilities:

• Perform activities related to manufacturing of products/finished goods to support manufacturing schedule.
• Ensure daily/monthly production targets are achieved.
• Ensure products are manufactured according to manufacturing/ assembly/ inspection procedures.
• Ensure Manufacturing Yield/Defect Rate targets are achieved
• Participate and collaborate with quality control in root cause analysis activity on non-conforming incident/excursion. Recommend and implement corrective and preventive action.
• Authoring change control and other documentation as required
• Perform qualification and technical selection of manufacturing equipment. Involve in method transfer and validation.
• Collaborate with cross function team (e.g. Quality, R&D, Supply Chain and Quality Assurance) on product transfer projects.

Job Requirements and Qualifications:

• Not less than 3 years of working experience in a manufacturing function preferred.
• Relevant experience in a biotechnology / medical device / pharmaceutical manufacturing industry.
• Completion of a bachelor’s degree in Biology / Biotechnology / Science or relevant degree at an accredited college or university.
• Knowledge of cGMP regulations, strong organizational skills, ability to multi-task with aggressive timelines and strong attention to detail.
• Strong interpersonal and team skills, ability to communicate and manage well at all levels of the organization.
• Strong problem solving and creative skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
• High level of integrity and dependability with a strong sense of urgency and results-orientation.
• Knowledge of MAC OS and Microsoft office applications 

Contact: Human.Resources@veladx.com