(Sr.) Research Scientist Jobs

A research-based biotechnological company located in Orange County, California. The company is developing meaningful disease solutions targeted at improving patient diagnosis with targeted biomarkers for precision medicine. With a distinct approach to R&D and a dedicated expert team, facilitate breakthroughs in molecular diagnostics with innovative platforms by integrating emerging technologies with a deep understanding of biological materials.

Key Skills:

IVD development

Biomarkers assays

Chromatographic techniques

Position Overview

We are currently looking for a (Sr.) Research Scientist to develop reagents and assays to enable new capabilities for biological workflows, and transfer technology from R&D to manufacturing. The (Sr.) Research Scientist will lead R&D efforts to develop reagents to enable new Biomarker/IVD assays and be responsible for timely product launches.

Responsibilities• Lead R&D efforts to develop reagents to enable new Biomarker/IVD assays. Examples of reagents include, but not limited to, surface chemistry reagents, critical raw materials (e.g., antibody, antigen, protein, peptides, DNA, RNA) and functionalized microparticles.)• Design experiments and research studies to test hypotheses and gather data that will inform the development of new products. Ensure the experiments are well-designed, controlled, and reproducible.• Collect data from experiments and other sources and analyze the data to draw meaningful conclusions. Use statistical and analytical tools to interpret the results.• Conduct thorough literature reviews to understand the state of art in the field and identify gaps that the research can address.• Identify potential areas of innovation and improvement.• Create prototypes of proof-of-concept models to demonstrate the feasibility of new product concepts.• Collaborate closely with cross-functional teams to ensure that the research aligns with the overall product development goals.• Ensure that the work complies with relevant regulations and standards.• Troubleshoot and solve technical challenges that arise during the development process.• Keep detailed records of experiments, results, and research findings for future reference and for meeting regulatory requirements.• Communicate the findings and insights effectively to both technical and non-technical stakeholders.• Oversee the transfer of new reagents from R&D to Manufacturing. This includes relevant documentation and appropriate quality control (QC) procedures. Support the scale-up of reagent manufacturing.• Provide technical guidance to research associates. Act as a mentor to team members.• Collaborate with suppliers to synthesize custom reagents and characterize reagents using appropriate analytical techniques, as needed.• Be responsible for completing projects and other assignments from upper management on time.

Education• Ph.D. or MS in Chemical Engineering, Chemistry, Bioengineering, or related disciplines.

Experience• Minimum 1-3 years of related industrial experience in IVD R&D for PhD• Minimum 8 years of related industrial experience in IVD R&D for MS

Requirement• Must be willing to handle human whole-blood, plasma and/or serum samples.

Preferred Skills• Experience developing IVD and life science reagents.• Bio-conjugation experience - involving the chemical modification and conjugation of proteins, peptides, and nucleic acids.• Experience with protein extraction and isolation a plus.• Proficiency in protein characterization (SDS-PAGE, Western blot, HPLC, etc.)• Proficiency in purification techniques for both macromolecules and small molecules, such as chromatography (IEX, SEC, and affinity).• Fundamental understanding of physical, chemical, and biological phenomena which govern biological assays.• Experience with immunoassay assays and related techniques is a plus.• Rigorous scientist with a record of developing robust, transferrable processes. Data-driven, proficient with the design of experiments (DOE), and statistical analysis.• Ability to thrive in a dynamic company with demanding schedules and deliverables.• Outstanding collaborative, interpersonal, verbal, and written communication skills toclearly articulate ideas, problems, and solutions within a highly interdisciplinary environment.