BioSpace has been engaged to help our client, a global provider of Point of Care (POC) medical diagnostic systems and solutions company, to hire a highly motivated scientist to join its product development in support of the company's product pipelines.
Job Duties include:
- Work with lead scientist and product manager to research, develop and improve POC medical diagnostic products
- Participate in product development including feasibility, verification and validation, and manufacturing transfer to ensure that products are in compliance with CFDA, FDA and EU regulatory requirements and standards for clinical in vitro diagnostics applications.
- Prepare/fabricate microfluidic immunoassay devices for Covid-19 PCR test: from reagent formulation, reagent dispensing, and prototyping/assembly up to complete device system.
- Conduct experiments to verify and validate device performance, ensuring that it meets or exceeds claims of product specifications and regulatory requirements.
- Analyze, summarize, and report data generated from experiments, draw conclusion from experimental results and suggest follow-up actions based on prior experimental findings.
- Assist in transfer from product development to manufacturing, providing detailed and complete technical information and documents related to the transfer process.
- Work closely with QC Department in providing Design Control Documents by following historic documents and resolving issues involving parts/products quality and regulatory/audit requirements.
- Provide technical support to product marketing and sales
- Coordinate with other researchers and professionals in support of internal and external audits.
- Perform other assignments, duties and assume additional responsibilities as required.
Job qualifications include:
- PhD in Biochemistry or related fields with 0 - 2 years’ experience
- Lab experience with antibody, biosensors, microfluidics or immunoassay preferred
- Experience in manufacturing management desired
- Strong written and verbal communication skills. (Mandarin language is a plus)
- Ability to learn new skills and work in a fast-paced, highly productive and changing environment; flexibility and quick adaptability to shifting priorities.