Research & Development Manager

3 weeks ago


Asheville, United States Genova Diagnostics Full time

Position Summary:

The Development Manager is responsible for the development and validation of new and current tests under the direction of the Lab Directors.

Technical

Maintain familiarity with validation requirements of regulating agencies. Assist in the design and carrying out of experiments for validation of tests. Develop and maintain timeline details for validation project activities and milestones. Collect, analyze and document data. Review and oversee assembly of validation documentation. Facilitate the writing of SOPs on newly validated tests for operations. Facilitate training of laboratory staff when new test is moved from R&D into the laboratory department.

Other

Works closely with Development Technologists, Documentation Management and Data analyst, Lab Directors, Lab Technical Managers and Supervisors, VP Laboratory Operations, QA department and Product Management Office.

Supervisory Responsibilities:

This job has direct supervisory responsibilities of the Development Technologists.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Organizational, communication and problem solving skills are most important. Attention to detail is a must. The requirements listed below are representative of the knowledge, skill, and/or ability required. The Development Manager must be self-motivated and possess the ability to work independently. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

This position requires a Bachelor's degree in chemical, physical or biological science or medical technology from an accredited institution required. Master's degree or above required. Minimum of two years' experience in a clinical laboratory setting. Previous experience with research and the validation of clinical laboratory assays is required. Minimum of two years. Previous experience with HPLC, GC/MS, ICP-MS, LC-MS/MS, ELISA, molecular and microbiology techniques desirable. #J-18808-Ljbffr


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