Principal Scientist

We are seeking a highly skilled and experienced Senior Scientist specializing in Molecular Biology to lead our efforts in the development and validation of high complexity laboratory tests. This position is based in our state-of-the-art facility in Baltimore, MD, where we are dedicated to advancing clinical diagnostics through innovation and precision. The ideal candidate will have a strong foundation in molecular biology, with extensive experience in designing and validating complex diagnostic tests. This role is pivotal in driving our research and development efforts, ensuring the delivery of cutting-edge diagnostic solutions to healthcare providers and patients.

• Lead the development, optimization, and validation of high complexity molecular diagnostic assays in compliance with CLIA, CAP, and FDA regulations.
• Design and execute studies to evaluate the performance characteristics of new tests, including analytical sensitivity, specificity, accuracy, precision, and reproducibility.
• Oversee the implementation of new technologies and methodologies to improve test performance, efficiency, and scalability.
• Collaborate with cross-functional teams, including bioinformatics, quality assurance, regulatory affairs, and clinical operations, to ensure the successful translation of research findings into clinical applications.
• Validation: Oversee and conduct rigorous validation studies to ensure the accuracy, sensitivity, specificity, and reproducibility of NGS assays.
• Develop and implement quality control measures. Develop and maintain standard operating procedures (SOPs), validation protocols, and other technical documentation in accordance with regulatory standards.
• Documentation and Compliance: Oversee development of detailed records of experimental protocols, data, and analyses. Ensure all research activities comply with regulatory standards and laboratory SOPs.
• Serve as a subject matter expert in molecular diagnostics, providing technical guidance and mentorship to junior scientists and laboratory personnel.
• Stay abreast of the latest scientific advancements and technological innovations in molecular diagnostics to foster continuous improvement and innovation within the laboratory.
• Contribute to scientific discussions, manuscript preparations, and presentations at internal meetings and external scientific conferences.

• PhD in Molecular Biology, Biochemistry, Genetics, or a related field, with at least 5 years of post-doctoral experience in a clinical diagnostics or biotechnology setting. Alternatively, a Master’s degree with 8 years of relevant industry experience.
• Demonstrated expertise in the development and validation of molecular diagnostic assays, including but not limited to PCR, qPCR, NGS, and other nucleic acid amplification techniques.
• Familiarity with bioinformatics tools and data analysis software relevant to molecular diagnostics.
• In-depth knowledge of regulatory requirements and quality standards governing high complexity laboratory testing (CLIA, CAP, FDA).
• Proven track record of scientific publications and presentations in the field of molecular diagnostics.
• Strong leadership skills, with the ability to manage and mentor a team of scientists and technical staff.
• Exceptional problem-solving abilities and analytical skills.
• Excellent communication skills, capable of effectively presenting data and insights to both scientific and non-scientific audiences.