Research And Development Scientist

IF INTERESTED CONTACT Trenton Burkley ASAP AT 847 767 7128 OR EMAIL YOUR RESUME TO tburkley @ actalentservices.com

Hours: Monday-Friday 8am-5pm (No weekends or Holidays)

MUST HAVE:

• Education in Medical Laboratory Science and ASCP Certified or Eligible

• Experience conducting research or testing on human specimens in a Clinical Laboratory across multiple areas (e.g., Chemistry, Special Chemistry, Molecular, Microbiology, etc.).

Description:

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.

• 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.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• 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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.