Analytical Development Scientist

Description

JOB OVERVIEW

The Analytical Development Scientist is in charge of method development, validation experiments, new menu additions, and other studies and projects that pertain to the Confirmation, Serology, and Microbiology departments using a variety of moderate-high complexity instruments. In addition, the Analytical Developmental Scientist ensures that validation experiments, proficiency testing programs, new project initiatives, and any additional studies are done according to CAP/CLIA standards and are done on time.

ESSENTIAL FUNCTIONS

• Provide method development and new method validation support for the Confirmation department, including toxicology and biomarker development on EIA and LC-MS/MS instrumentation
• Provide method development and new method validation support for the Serology department, including blood assay development on chemistry, hematology, immunoassay, and ELISA instrumentation
• Provide method development and new method validation support for the Microbiology department, including microbiology and molecular assay development on PCR and MALDI-ToF instrumentation
• Work with laboratory departments to ensure newly developed assays and instruments are integrated properly into daily workflows
• Write SOPs for new or modified processes
• Train laboratory scientists on new or modified processes
• Operate as the point-person for method development across all laboratory departments
• Operate as the point-person for new method validations, routine method verifications, new menu additions, and weekly/monthly verifications.
• Perform analytical measurement range (AMR) and instrument comparison studies when needed
• Ensure appropriate test method selection for the matrices and target analytes of interest to clients’ and doctors’ offices
• Work with the Quality Management team to ensure acceptable analytical test performance is established and maintained for each test system
• Determine which remedial actions are taken and documented when significant deviations from the laboratory’s established performance characteristics are identified and patient test results are reported only when the system is functioning properly
• Schedule meetings within laboratory departments when necessary
• Continuously monitor new developments throughout clinical testing industry and academic research to evaluate new technologies and methods that could improve upon current processes
• Other duties as assigned

Requirements

PROFESSIONAL REQUIREMENTS

• High level of attention to detail and organization
• Excellent verbal and written communication skills
• Excellent problem solving skills and logical approach to solving scientific problems
• Understanding and adhering to established protocols and procedures
• Ability to coordinate laboratory functions and represent the toxicology laboratory professionally 
• Ability to function seamlessly in a team environment 
• Ability to work in a laboratory environment, exposed to normal laboratory hazards and chemicals, including biohazardous materials
• Proficient in operating complex laboratory instrumentation and computers with scientific software applications
• Must be able to work with limited supervision where the work assignments are subject to established procedures, practices, precedents, methods, techniques, standards, and/or well-defined policies
• Must be able to plan and organize his/her work, and have ability to participate in method development, validation, or research with technical supervision
• Must be able to achieve superior results when work is reviewed in terms of quality, volume, timeliness, and adherence to established methods, standards, and policies
• Ability to listen, learn, and promote accountability and responsibility related to all method, instrument, calibration, and quality control processes

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor’s or Master’s Degree in Toxicology, Chemistry, Pharmacology, Biology, Physics, Life Science, or similar analytical science field
• Requires 3 years of experience with and advanced understanding of LC-MS/MS (liquid chromatography-tandem mass spectrometry) instruments, methods, and systems
• Preference for candidates with Agilent LC-MS/MS experience 
• Other experience in instrumental analysis of drugs in biological specimens may be acceptable
• Requires previous experience with method development, validations, and/or verifications in a high-complexity laboratory setting
• Previous work with bodily fluids such as urine, blood, or oral fluid preferred

KNOWLEDGE, SKILLS, AND ABILITIES

• An advanced understanding of drug metabolism, ADMET, toxicology, P450 enzymes, forensic testing, and/or testing principles specifically related to urine and oral fluid metabolism
• Strong interpersonal skills and the ability to effectively communicate with teams across the entire company, and directly with vendors and customers as needed
• Good understanding of quality and regulatory requirements in the laboratory industry, including CLIA and CAP regulations 
• Strong technical writing skills, including the ability to create procedures and reports to summarize and present data
• Ability to read, analyze, and interpret technical procedures and regulations
• Ability to write standard operating procedures (SOP) and policy manuals

PHYSICAL REQUIREMENTS

• Work may be performed in a laboratory environment and exposes the incumbent to normal laboratory hazards and chemicals, including biohazard materials
• Work in varying degrees of temperature (heated or air conditioned)
• Position requires sitting, walking, reaching, bending, stooping, and handling objects with hands and/or fingers, talking and/or hearing, and seeing
• Must be able to wear the appropriate personal protective equipment (PPE) as required

DIRECT REPORTS

• None