Additional Details

Roles & Responsibilities

PURPOSE

To design verification and validation procedures for rare cell isolation assay development

KEY DUTIES

• Design experiments and protocols for rare cell isolation and molecular diagnostic assay validation and verification.
• Establishing protocols and SOPs.
• Processing human clinical samples, such as tissues and blood.
• Ensure excellent collaboration within the organization among RnD, product development, QA/RA, Engineering, and sales and marketing teams
• Ensure excellent collaboration outside the organization among research and clinical collaborations, consultant, and regulatory authorities, and clients.
• Design experiments and protocols for assay validation and verification.
• Establishing protocols and SOPs.
• Ensure products are developed following Design Excellence principles such as ISO13485, cGMP, QSR, Lab Developed Test (LDT) guidelines.
• Ensure products are developed on time, on budget and on quality
• Ensure all legal and regulatory obligations are followed and implemented
• Communicating results to the scientific and clinical communities
• Collaborating with industry/academia to apply the results of research and develop new techniques, products, and implement best practices;
• Presenting ongoing work and findings to colleagues at academic and industry/commercial conferences, and producing posters which summarise the nature of their research, their methodology and their findings;
• Working in multidisciplinary teams across different functions of the business.

KNOWLEGE, SKILLS AND ABILITIES REQUIRED

• MS/PhD a Life Science, Biotechnology, bioengineering or other relevant subjects
• Preferably 5+ years of experience in molecular diagnostic assay product development.
• Preferable 5+ years of experience of using Next generation Sequencing (NGS) and PCR equipment.
• Preferably 2+ years of experience in developing rare cell isolation technique, such as circulating tumor cells (CTCs)
• Knowledge in fetal and maternal medicine is a plus.
• Knowledge in techniques and diagnostic tools in fetal and maternal medicine and prenatal diagnosis is a plus.
• Knowledge in instrumentation design is a plus.
• Must be familiar with techniques of immunochemistry staining, fluorescence microscope, DNA based molecular diagnostic assay development, Singal Cell sequencing, Whole Genome Amplification.
• Must be familiar with development and validation of Lab Developed Test
• 2+ years of project management experience; clinical trail experience is a plus.
• Preferably worked in a regulated environment and developed products following IVD guidelines (ideally FDA -510k, CE-IVD, or CFDA)
• Must have worked on the development of a new molecular diagnostic assay (e.g. the reagent part)
• Clear understanding of design control from a development perspective and the ability to communicate its key elements
• Positive personality which creates and fosters an optimistic work environment.
• Ability to communicate project status to senior management in an objective and positive manner.
• Sees himself/herself as a servant of the team whose job it is to empower and grow all team members, while providing supervision without micro managing.
• Having the ability to make tough decisions when needed to improve the quality of assay development
• Ability to clearly express a vision, strategy and technical details.
• Strategic thinking with attention to detail in its tactical execution.
• Requires excellent, organizational, written, interpersonal, and communication skills.
• Ability to interact successfully with different cultures.
• Work with others at all levels across the organization demonstrating a collegial and productive manner.
• Must be able to effectively work with multidisciplinary teams with and without direct supervisorial authority.
• Must have excellent data analysis and presentation skills.
• Exhibits strong bias for action and results orientation.
• Proven ability to interact with customers and KOLs.