Clinical Lab Scientist

Full job description Job Title: Clinical Laboratory Scientist - NGS Specialist Doc# G2024-02625 Location : Rockville, MD (on-site) Psomagen, Inc. is a leading CLIA-certified laboratory specializing in Next-Generation Sequencing (NGS) based high complexity tests. We are dedicated to providing cutting-edge genomic services to our clients, ensuring the highest standards of quality and compliance. We are seeking a highly skilled and experienced Clinical Laboratory Scientist with a strong background in NGS technologies and clinical genomics to join our team. The successful candidate will play a critical role in designing and implementing CLIA validation plans, ensuring compliance with regulatory requirements, and effectively communicating with clients, the sales team, and the laboratory director. Responsibility Design and implement CLIA validation plan for NGS-based assays, ensuring compliance with CLIA regulations and guidelines. Communicate with clients to understand their needs and provide technical expertise and support throughout the validation process. Develop and execute proficiency testing programs to maintain high standards of assay performance and quality. Collaborate with the laboratory director to ensure all laboratory activities comply with CLIA regulations and other relevant standards. Oversee the development and optimization of clinical assays, utilizing NGS technologies. Perform routine and complex laboratory tests, analyze data, and report results accurately and in a timely manner. Maintain detailed and accurate records of all laboratory activities, ensuring documentation meets regulatory requirements. Stay up-to-date with advancements in NGS technologies and regulatory changes affecting clinical laboratory operations. Provide training and mentorship to junior laboratory staff as needed. Collaborate with the sales team to effectively represent Psomagen's clinical laboratory capabilities to potential and existing clients. Actively engage with clients to promote Psomagen's services and capabilities, addressing their inquiries and providing solutions to meet their needs. Qualifications Master's degree or higher in Clinical Laboratory Science, Molecular Biology, Genetics, or a related field. Minimum of 5 years of experience in a clinical laboratory setting, with a focus on NGS-based testing and high complexity assays. In-depth knowledge of CLIA regulations and guidelines, with demonstrated experience in designing and implementing CLIA validation plans. Strong background in NGS technologies, including library preparation, sequencing, and data analysis. Experience in developing NGS-based genetic tests is preferred. Excellent communication and interpersonal skills, with the ability to effectively interact with clients, sales team members, and other stakeholders. Detail-oriented and highly organized, with a strong commitment to quality and compliance. Ability to work independently and collaboratively in a fast-paced and dynamic environment. Benefits Medical, dental, and vision insurance (Monthly insurance premium is covered 100% by the employer) 401K with immediate participation and company match after 1 year 24 days of paid time-off with roll over or cashing option Long-term employment cashable vacation 2-hour off for an annual check-up Team Lunch allowance and drinkware reimbursement Visa sponsorship is offered when needed Money Gifts for congratulatory/condolences Company Overview: Psomagen, Inc., founded in 2004 in Rockville, MD, is at the forefront of genetic and genomic testing. The company offers cutting-edge genomic services through next-generation and Sanger sequencing with data analysis services for applications in basic research and clinic diagnostics. The service laboratory has been certified under the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP), which demonstrates the highest level of quality and safety in the market. Listed on the KOSDAQ in July 2020, the company is rapidly expanding its business from B2B to B2C and from Research to Clinical markets. The company has broadened the capabilities in the healthcare space such as at-home kits for analysis of genetic traits and microbiome profiles. With CLIA-certified and CAP-accredited laboratories, the company is looking to further expand service offerings in the clinical laboratory diagnostics market such as a laboratory-developed test (LDT) for COVID-19.