Prometheus Laboratories is a forward-thinking clinical diagnostics company that is dedicated to disrupting the treatment paradigm of GI and autoimmune diseases. We do this by discovering and developing a broad portfolio of novel, precision-based diagnostic testing solutions that meaningfully impact patient care throughout their individual healthcare journey. From patient-personalized diagnosis and prognosis, disease profiling, therapeutic selection through disease monitoring, the Prometheus suite of tests is purpose-built to take the guess work out of critical patient care needs. Our ambition is to expand our team with like-minded leaders with shared passion and dedication for transforming the future of precision-guided patient care.
Hands-on and independent position that is responsible for leading the development, validation, design transfer, and maintenance of diagnostic tests for the Clinical Laboratory.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Independent contributor to lead activities for the development and launch of novel diagnostic tests and technical support of existing tests
- Takes direction from management to meet project goals and timelines
- Independently devises and performs development, optimization, investigation, and new technology assessment studies
- Leads the design & development, establishing of specifications, validation & verification, design & process transfer, launch & implementation activities to include post-launch monitoring, maintenance & troubleshooting
- Author and/or revise SOPs, forms, policies, batch records, proposals, reports, investigations, and notebook write-ups
- Data analysis using complex algorithms and methods in statistical analysis to draw conclusions with recommendations for implementation
- Creates and maintains databases for the quality control of diagnostic tests, clinical samples, analytical studies, and clinical studies
- Provide summary reports and give presentations to project teams and departments
- Maintains knowledge of scientific literature pertinent to ongoing projects
- Complies with CAP/CLIA requirements, safety and other guidelines as needed
May supervise employees, either directly or via matrix management. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; addressing issues and resolving problems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Position generally requires a PhD degree in biological and life sciences with 0-2 years or an MS degree 6+ years or a BS degree with 10+ years of industrial experience with developing and launching diagnostic tests. Generally requires 0-2 years of managerial/leadership experience. Experience in clinical diagnostic service laboratory, or medical device industry strongly preferred. Deep knowledge in protein chemistry, immunology, molecular biology and hands-on experience related their diagnostic methods and clinical applications development required. Experience working in GLP/GMP/FDA and/or CAP/CLIA regulated atmosphere is strongly preferred.
Ability to read and analyze professional journals, technical procedures, and governmental regulations is required. Ability to write reports, business correspondences, procedure manuals and SOPs. Ability to effectively present information and respond to questions.
Ability to apply mathematical concepts and operations to test reliability and validity of data. Proficiency in Excel is required.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of technical instructions in mathematical, written or diagram form.
CERTIFICATES, LICENSES, REGISTRATIONS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold.
The noise level in the work environment is moderate.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.