Job Purpose Stemina is seeking a Laboratory Director to lead the growth of laboratory operations for the NeuropointDX clinical diagnostics division. The ideal candidate will bring experience of building and running a CLIA laboratory. Certification as a CLIA Laboratory Director with capabilities for obtaining registration in all 50 states is a requirement. Stemina has recently obtained CLIA registration in Wisconsin and is looking to broaden this capability to all states. Stemina has a strong laboratory team in place and is open to structuring the position as part time/remote opportunity with flexible hours. R&D activities at Stemina are identifying additional biomarkers for which CLIA compatible assays are being developed as part of its autism program. Experience in configuring, validating and transitioning new tests from R&D into operations ensuring CLIA compatible processes are established are also very important. This role will need to have a working knowledge of Mass Spec-based biomarker discovery and will work with the existing scientific team to ensure assay designs are appropriate and that they are well validated prior to commercialization. Development of additional diagnostic assays will follow the initial autism focused tests. It is expected that the candidate will be hands on with respect to the science including experimental design, data analysis, data interpretation, and will ensure the company is using processes and quality measures for robust assays. A clear track record of successes as a team leader demonstrating the ability to be communicative, inquisitive, self-motivated, self-directing, problem solving, as well to develop realistic project plans with timelines must be evident.
Essential Job Duties and Responsibilities • Leadership and supervision of a growing team of laboratory-based scientists including the development and execution of a strategy to maintain appropriate laboratory capabilities in line with business goals. • Designing, implementing, and maintaining operations of a CLIA facility able to support a high-volume biomarker based diagnostic tests across the United States. • Assist in design and execution of scientific metabolomics experiments in collaboration with bioinformatics, analytical chemistry and cell biology staff to facilitate validation and transfer of new assays into the CLIA facility. • Working closely with the Quality Assurance Manager, adapt and maintain a quality plan for CLIA activities as the company needs dictate. • Develop and follow SOPs to analyze targeted and discovery based metabolomic experiments in line with the company’s Quality Program. • Work with regulatory agencies to obtain and subsequently maintain CLIA certifications. • Keep and maintain accurate and detailed records of all research and experiments performed.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty well. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and Experience: • An advanced degree in biological laboratory science or MD and hold an active license, or readily obtain a license, as a CLIA Laboratory Director in the state of Wisconsin. • Capability of obtaining the ability to offer CLIA tests in all 50 states. • A minimum of 5 years post graduate experience (industrial experience strongly preferred) in running a clinical laboratory including staffing, supervision, and technology transfer. • Demonstrated experience in the validation and use of high complexity assays as defined under the CLIA regulations.
Knowledge, Skills and Abilities Required: • Effective interpersonal, verbal and written communication skills, including public-speaking and presentation skills. • Ability to maintain high level of confidentiality. • Ability to effectively communicate with all levels of the organization and CLIA regulatory agencies. • Demonstrated ability to work well independently as well as a part of a diverse team. • Demonstrated ability to organize and manage multiple tasks given the dynamics of a growing company with changing priorities. • Demonstrated ability to troubleshoot problems, recommend resolutions, and implement solutions. • Knowledge of implementation of effective quality processes for high complexity tests. • Advanced analytical, organizational, and record-keeping skills. • Proficiency with the Windows and MS Office.
Stemina uses metabolomic technologies to study biology and disease in market areas important to human health. NeuropointDX, Stemina’s diagnostic division, is commercializing a diagnostic platform of metabolite assays derived from biomarkers identified at the company involved in health and diseases such as cancer, autism and others. The company’s Children’s Autism Metabolome Project (CAMP), is the ...largest metabolomics study of autistic children ever conducted. This ongoing study is designed to discover biomarkers and develop assays for the early diagnosis of autism which can be marketed through our CLIA laboratory as high complexity laboratory developed tests. Stemina’s also uses pioneering cell based assays arise from the strategic convergence of the groundbreaking technologies metabolomics and human embryonic stem cells. In addition, Stemina provides drug screening, drug discovery and diagnostic development services for pharmaceutical and biotechnology companies under service contracts or joint discovery agreements using its proprietary metabolomics platform.