Senior R&D Clinical Scientist

Job Description

Agile Clinical is the world’s most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.

Overview

We are seeking a Senior Scientist, for one of our clients a high-complexity CLIA lab in Vancouver, WA that is developing new at-home collection-based diagnostic tests. The incumbent must have the most updated scientific knowledge about assigned project. R&D research projects is under the supervision of a Principal Investigator. Research projects include developing gene assay, ELISA-based protein biomarker detection assay, and other assays relevant to clinical diagnostic tests. Other tasks include organizing materials, prepare samples, and organizing/maintaining paperwork for research projects, and other tasks when applicable. Must be able to communicate with external collaborators or clients and support the scientific discussions. Training and mentoring junior position colleagues.

Responsibilities

• Initiates, directs, and executes scientific research and development that is critical to corporate strategies and image. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, projects and problems.
•  Plans and executes laboratory research. Report the PI regularly to update the project results and carryout the projects to meet timeline. Maintains a broad knowledge of state-of-the-art principles and theory.
• Makes major contributions to scientific literature and conferences. May act as spokesperson on corporate research and development. May be responsible for management and professional development of research group as well as the production teams. Interfaces with various departments.
• Projects require expert and extensive knowledge of advanced principles, theories, and concepts in area of expertise. Contributes to the development of principles and concepts new to the field. Often acts as project leader. Handle clinical sample collection drive.
• Serves as organization consultant and spokesperson on specialized projects or programs. Acts as advisor to top management and customers on advanced technical research studies and applications.  Interact with other sections/divisions and support on routine matters (Clinical sample testing).

• Excellent interpersonal and communication skills in both verbal and written communications and excellent customer service skills in a culturally diverse organization
• Contribute to the team research environment in a manner conducive to the success of the research project as a whole.
• Assist training new testing personnel.

Qualifications

• PhD in a scientific discipline with at least 5+ years’ experience in CAP/CLIA lab or clinical research experience or a master’s degree with 5+ years’ experience in CAP/CLIA lab or clinical research experience, or a bachelor’s degree with 10+ years’ experience in CAP/CLIA lab or clinical research experience (or showing the equivocal talent/skills at Molecular for at least 6+ years)
• Expert knowledge of scientific principles and concepts is also required.
• Must have regulatory affairs experience (CAP and CLIA) and FDA 510(k) or other FDA submission
• Excellent interpersonal and communication skills in both verbal and written communications and excellent customer service skills in a culturally diverse organization
• Ability to work as part of a team within a highly collaborative environment
• Ability to adapt in a constantly changing environment and the ability to work under tight deadlines
• Able to develop specific goals and plans to follow the priority assigned. Organize and accomplish projects in a timely manner
• Able to manage the working hours for yourself as well as a group of projects
• High level of accuracy is required with a special attention to detail
• Experience in a minimum of 9 areas listed below is required.
  • Pharmacology/Pharmacogenetics
  • General clinical chemistry (hematology and biochemistry diagnostic tests)
  • Microbiology
  • ISO regulation/requirements (e.g., ISO17025)
  • Immunoassay (ELISA/EIA)
  • Western blot
  • HPLC
  • LC/MS
  • Solid phase extraction
  • DNA extraction and Sterile technique
  • RT-PCR and Proficient with pipetting low volumes (<3µL)
  • Robotics/automated high throughput system for molecular assay and/or EIA assay
  • Data analysis
  • CAP/CLIA regulatory requirements
  • Must have at least 5 years of lab experience with BSL2 materials

• Strong knowledge of general data analysis, statistics and statistical process control
• Demonstrates exceptional understanding of the elements that support high quality work processes, training and quality assurance in laboratories
• Research techniques in molecular, protein chemistry, LC-MS/MS, or others
• Must have knowledge of biological analysis, quantitative and qualitative analysis, tabulation of data, equipment calibration, and standard laboratory equipment
• Strong computer literacy knowledge. Must be excellent user of MS Office
• Knowledge of genetic data analysis software (sequencing, alignment, and/or NGS library) is a plus
• Must have knowledge of CLIA and CAP regulations
• Knowledge of occupational safety and health rules and regulations.

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