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.
