R&d Scientist
Actalent
- Hoffman Estates, IL
- Contract
- Full-time
- Applies the principles, theory, and techniques of Good Laboratory Practices (GLP) to produce and report appropriate clinical laboratory results;
- Monitors test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained;
- Develops new tests/assays and/or improvements to existing tests, with guidance from the Laboratory Director and Principal R&D Scientist/Manager;
- Implements new/improved tests in the clinical laboratory;
- Maintains complete and accurate documentation of data generated and work performed (e.g., detailed evaluations of methods, product development or equipment, etc.);
- Writes formal validation plans and reports;
- Retains appropriate records of all activities and keeps records in an organized file;
- Organizes method validation material and prepares validation packets for review by the development team, with input from laboratory director, and submits to the Laboratory Director/Principal R&D Scientist and QA;
- Reviews and analyzes statistical analysis plans and data sets with Principal R&D Scientist and/or QA and Laboratory Director;
- Serves as a resource following test implementation;
- Participates in writing SOPs and training checklists and in the training of laboratory staff;
- Reviews literature and competitive information for R&D planning and analysis of results;
- Collaborates with various groups for study level publication planning including manuscript writing and submissions;
- Collaborates to achieve publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts;
- Generates documents to support regulatory submissions and/or responds to questions from regulatory authorities about existing submissions;
- Records corrective action when necessary;
- Performs preventative and corrective maintenance on instrumentation as described in procedures and/or manufacturer specifications;
- Assists in the investigation, installation, and evaluation of laboratory equipment and other specialty items;
- Oversees Collection Events;
- Records quality investigations and corrective actions, where appropriate; and
- Performs other duties/projects as assigned by the manager or Laboratory Director.
- Investigates and assists in purchase of laboratory equipment related to developmental activities.
- Investigates potential laboratory purchases including equipment, instruments, reagents, computer hardware and software, and other specialty items prospective to or as a result of development;
- Requests price quotes, installation, and delivery information; and
- Participates in instrument installation, validation, and vendor supported training.
- Understands clinical laboratory testing and workflow/operations. Utilizes this knowledge when developing tests/methods for the laboratory;
- Participates in editing/updating laboratory procedures resulting from developmental improvements;
- Assists with instrument and method troubleshooting.
- Uses a systematic approach in solving problems;
- Analyzes problems and evaluates alternate solutions;
- Uses data in developing solutions to problems; and
- Uses appropriate math and statistical problem solving tools.
- Specifically looking for someone to develop LDT tests on the AU680, Centaur CP and by ELISA from DBS.
- Masters Degree with 1 years of experience in a Clinical Laboratory or an equivalent combination of education and work experience.
- Bachelors Degree and/or MLT or MLS with 2 years of experience in Clinical Laboratory or an equivalent combination of education and work experience
- Experience conducting research or testing on human specimens in a Clinical Laboratory across multiple areas (e.g., Chemistry, Special Chemistry, Molecular, Microbiology, etc.).
- Experience and strong knowledge of data analysis and interpretation skills.
- Strong leadership skills as it requires significant interaction with executive leadership, physicians, and regulatory authorities
- To perform this job successfully, an individual must be able to perform each essential duty competently
- ASCP Certified or Eligible
- Performs tasks which involve exposure to blood, body fluid, or tissue.
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people