Clinical Scientist of Pathology (NGS) in Livingston

Yoh Life Sciences is hiring a Clinical Scientist of Pathology (NGS) in Livingston, NJ for our leading healthcare customer. The individual will hold a PhD with strong experience working in a clinical pathology lab setting following CLIA and CAP regulations. You must have experience with NGS and a minimum of 2 years in an industry clinical pathology testing lab. If PhD has been obtained outside of the US, it will need to have been evaluated by the US to ensure it meets current US standards. Relocation will be offered for non-local candidates.

Duration: Permanent

Salary: $135k - $180k

Schedule: M-F 8-5pm

Responsibilities:

• Technical and scientific oversight of the laboratory including selection of appropriate test methodology.
• Verification of test procedure analytical performance.
• Establish and maintain the quality control program including acceptance criteria throughout the entire process from raw material receipt to reporting of test results.
• Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from established specifications.
• Experience in a regulated clinical laboratory environment meeting CLIA/CAP/NYS DOH/ISO 15189/ISO 13485 standards.
• Perform hands-on, wet lab experiments to evaluate existing genetic testing assays, leading to assay improvements.
• Use scientific methods and best practices for experimental protocol design, execution, data analysis, and interpretation.
• Liaise with R&D team to ensure successful new product introduction by employing rigorous validation protocols and methods.
• Analyze and interpret genetic testing output from data analysis pipelines to assess data quality, support the interpretation of sequencing results, and identify trends for optimization.
• Aid in troubleshooting and root-cause analysis, and devise solutions and approaches for solving technical problems to improve genetic testing performance in an inclusive and collaborative fashion.
• Drive technology transfer and implementation of new products or assay improvements.
• Will include authoring or contributing to development of SOPs, work instructions, etc.

Qualifications, Knowledge, Skills and Abilities:

• In-depth technical knowledge, proficiency and prior experience with clinical pathology, molecular biology, genomics, and associated discipline-specific analytical tools, as well as statistical methods is required.
• Experience with Sanger and Next Generation Sequencing methods and output required.
• Hands-on experience with bioinformatics and bioinformatics tools for sequencing data to enable experimental iteration independent of external support will provide an advantage.
• Experience in process, method, or assay development and optimization with thorough understanding of verification and validation methods is required.
• Familiarity with more advanced techniques like DOE is an advantage.
• Ability to plan activities and lead technical teams or work independently with minimal direction - required.
• Experience with Good Documentation Practices and ability to maintain detailed records of experiments and outcomes required.
• Experience writing and authorizing SOPs, test methods, and reports required.
• Advanced computer skills (Microsoft Office, Minitab, CAD or equivalent) are required.
• Excellent interpersonal and effective communication skills with internal and external stakeholders ranging from fellow scientists and stakeholders within the company to external parties (customers, vendors etc).

Experience: 5+ years experience in a high complexity clinical laboratory setting, minimum of 2 years in molecular pathology.

Education: PhD within the Life Sciences with specialized training in molecular pathology. Minimum of 5 years experience in a clinical laboratory setting. ASCP certification/NYS CQ preferred.

Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities