Responsible for creating, optimizing, developing, updating, and sustaining diagnostic assays and reagents in a regulated environment while driving innovative solutions. Design and develop new biomolecules or reagents, collect and manage biological samples to support method/product development, identify emerging technologies and trends related to diagnostics. Provide technical assistance to support existing products, methods, or techniques. Performs analytical verifications and documents validation activities and outcomes for regulatory submissions.
Primary DutiesPrepares protocols and summary reports.
Performs data collection, interprets, and draws conclusions to continue the development process.
Handles biological samples contained in human blood.
Uses aseptic technique to process bacterial samples.
Manages assigned projects and their equipment management.
Contributes to quality improvements and equipment management.
Ensures the project results and files are accurately documented and compliant with the company quality assurance and design control procedures.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.
Required Education, Training and Experience
Bachelor’s degree required in Life Sciences (Microbiology, Biology, Biotechnology).
Ability to remain in stationary position, either sitting or standing, for prolonged periods: Yes
Ability to ascend/descend stairs, ladders, ramps, and the like: No
Ability to wear PPE correctly most of the day: Yes
Ability to operate heavy machinery: No
Ability to move objects up to 50 pounds in all directions: Yes
Domestic travel required: 5%
International travel required: 5%
Total travel required: 5-10%
Position is lab-based and follows work practices for working with laboratory biohazards and chemical hazards.