Senior Assay Development Scientist

BIOCHEETAH PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading biotechnology company in Singapore is seeking a Senior Assay Development Scientist to lead the development of ELISA and Point-of-care test kits for urological cancers. The ideal candidate will have a degree in Molecular Biology or related field and at least 5 years of R&D experience. Responsibilities include contributing to ISO 13485 quality activities and overseeing diagnostic software development efforts.

Qualifications

• Minimum 5 years’ experience in R&D work.
• Ability to work with little supervision.
• Must be a team player.

Responsibilities

• Develop ELISA and Point-of-care test kits for urological cancers.
• Contribute to quality activities relating to ISO 13485.
• Lead in diagnostic software development efforts.
• Conduct validation studies using clinical samples.
• Collaborate to accelerate productization of IVD products.

Skills

Strong proficiency in antibody usage in immunoassays

Experience in immunoassay development for diagnostic purposes

Good foundation in molecular biology techniques

Experienced in mammalian suspension cell culture

Strong knowledge in experimental data analysis

Problem-solving skills

Communication skills

Planning and organization skills

Communication skills

Education

Bachelor's or Master's degree in Molecular Biology, Biotechnology, Life Sciences

Tools

Minitab

GraphPad Prism

Microsoft Excel

R

Job description

Job Overview:

The Senior Assay Development Scientist will usually carry out experiments and research independently but will typically be part of a larger team and will share the findings and relevant information with colleagues. The candidate will be heavily involved in the design, optimization, and validation of analytical assays used in BioCheetah’s biomedical research and diagnostics development.

Key Responsibilities:

• Develop both ELISA and Point-of-care test (POCT) kits immuno-based diagnostics kits for urological cancers.
• Define immunoassay format, technical specifications, parameters, and characteristics leading to prototyping.
• Perform verification studies on optimised immunoassay using pre-pilot production.
• Play a key role in design input and product requirements.
• Contribute actively to quality activities relating to ISO 13485 such as risk management process, Failure Modes and Effects Analysis implementations (FMEA), traceability matrix, drafting of technical specification documentation and project planning.
• Lead in diagnostic software development efforts including preparation of documents relating to software development such as Software System Requirements Document (SSRD), Software Architectural Design (SAD), Software Requirement Traceability Matrix (SRTM), Software Detailed Design (SDD) Software Hazard Analysis (SHA), and Software Development Plan (SDP).
• Conduct validation studies using clinical samples on design freeze prototype.
• Close collaboration with scientists and other stakeholders to accelerate the productization of BioCheetah’s IVD products.

Minimum Qualifications:

• A Bachelor’s or a Master’s degree in Molecular Biology, Biotechnology, Life Sciences or related discipline.
• A minimum of 5 years’ experience in R&D work.

Experience and Skills:

• Strong proficiency in antibody usage in immunoassays with techniques in ELISA, western blot and dot blot.
• Experience in immunoassay development for diagnostic purposes.
• Prior experience in usage of clinical samples for immunoassay work.
• Good foundation in molecular biology techniques eg. DNA cloning and RT-PCR.
• Experienced in mammalian suspension cell culture and general tissue culture techniques.
• Strong knowledge in experimental data analysis and experience in usage of analytical software such as Minitab, GraphPad Prism, Microsoft Excel or R. Strong proficiently in Minitab is desirable.
• Experience in technical specification writing for immunoassay products.
• Strong skills in problem-solving, communication, planning, documentation and organization.
• Ability to work with little supervision.
• Ability to pay keen attention to detail at all times.
• Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects.
• Must be a team player.
• Must exhibit a great level of self-discipline.
• Proficient user of basic computer applications for the execution of daily project operations.