What are the responsibilities and job description for the Part-time Clinical Laboratory Scientist position at Research & Development Institute, Inc.?
About RDI
RDI is a project-based laboratory that specializes in collecting and testing patient samples to evaluate lab instruments that are not yet available on the market. Since our founding in 2008 by a scientist, we've successfully managed over 150 clinical trials and tested thousands of samples. Our mission is more relevant than ever. As the COVID-19 crisis has demonstrated, accurate laboratory testing is critical-and the work we do at RDI directly contributes to the development of better diagnostic tools for everyone.
Position Summary
The Clinical Research Laboratory Scientist will lead clinical trial protocols for method comparison and precision validation for Immunodiagnostic Assays and is in charge of day to day operations.
This opportunity is a full-time permanent position with benefits and an aggressive salary. This is a significant leadership position which offers excellent career-advancing experience which has been very beneficial for those who have excelled in this position for us around the country.
The preferred candidate has experience with Siemens, Roche, Abbott, Biorad and Beckman instruments as well as a familiarity with Clinical Testing Protocols and the IRB process.
The Scientist role requires the ability to write protocols, execute studies, and write reports for medium to high complexity equipment and processes. This position is constantly cross functional in nature and requires independent thought and schedule adherence, under low levels of guidance from the Laboratory Operations team. The Scientist also provides guidance to other team members.
Responsibilities
- Coordinate and perform validation projects and protocols in support of equipment, method, and process validation of high complexity.
- Conduct validation tests for new assays, instrumentations and methodologies.
- Work with Chief Science Officer to generate performance qualification, method comparison, and validation reports.
- Manage lab inventory for new and existing projects.
- Record assay development work in the scientific notebooks for reference purposes.
- Troubleshoot instruments, methods, procedures, and in writing protocols and reports
- Communicate with clients, coordinate our activities with their other testing
- Willingness to travel to manufacturer in-house training sessions and industry sponsored symposia
- Using scientific principles, compliance knowledge, to design and execute validation strategies that meet quality and efficiency goals of our clients.
- Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product and process validation.
- Performs root cause analysis and suggest workarounds and/or solutions for recurring issues of high complexity.
- Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behavior (always stay above the line).
- Performs all job duties in a safe manner, consistent with the Code of Ethics
Minimum Requirements
- Bachelor's degree in Biology, Chemistry, or similar Life Science field
- Relevant experience in In Vitro Diagnostics medical field
- Good analytical skills, with an ability to use scientific knowledge and statistical methods/DOE to identify root causes of process and product failures
- Demonstrated technical skills in process validation and concepts with an emphasis on implementation
- Excellent verbal and written communication skills
- Previous experience in problem solving methodology
- Proficient in use of Microsoft Office Suite and excellent Excel skills
- Able to work independently, with little guidance from Technical Operations team
- Ability to learn new products and technology at a fast speed
- Hands on knowledge of moderate to complex microbiological lab skills and techniques required
- Able to successfully lead a project involving a group that may include participants from all levels of the business
Preferred Qualifications
- Previous experience in microbiological assay development, protein purification/solid-phase immunochemistry, and PCR techniques
- Strong project management and organizational skills
Salary : $1 - $9,999,999,999
