Job Description: Apply advanced scientific expertise and methods to design develop and implement drugs of abuse mass spectrometry assays. Conducts development feasibility and validation studies applying advanced scientific principles to projects or products of strategic importance to the organization. Trains and guides scientific personnel at various levels as needed and offers scientific design and statistical analysis to assigned projects.
Plans research methodology and formulates experimental designs for medium to largescale projects. Plans and conducts experiments records data and identifies issues and opportunities observed during the research process. Possesses strong knowledge of scientific methods and establishes logical research procedures. Proficient in statistical methods and Design of Experiments techniques. Understands the product development process and concepts of design for manufacturability.
Oversees and validates the recording of experimental results in authorized companyowned laboratory notebooks for all staff members involved in medium to largescale projects. Periodically reviews and cosigns notebooks to verify the accuracy of recorded results and intellectual property concepts.
Promotes innovation and original thinking in the execution of development tasks for medium to largescale projects. Leads project staff towards new developments in technical expertise.
Assist in preparing technical SOPs assay validation reports and other assayrelated documentation for medium to largescale projects. Leads project presentations or demonstrations to customers or management demonstrating excellent oral and written communication skills. Interacts with project team members peers other divisions customers and suppliers to resolve daytoday issues and achieve results.
Drives compliance with industry regulatory and quality standards for Assay Design Control processes.
Knowledge:
Ability to design and develop LCMS/MSbased assays for the detection and quantification of target analytes in biological specimens (urine oral fluid hair).
Experience optimizing assay parameters such as sample preparation chromatography and mass spectrometry conditions to achieve high sensitivity specificity and accuracy.
Experience in a GMP or QSR environment preferred.
Experience with relevant scientific computing applications.
Analyze and interpret LCMS/MS data to generate accurate and reliable results.
Maintain and troubleshoot LCMS/MS instrumentation and software with little assistance.
Ability to lead a mass spectrometrybased project with minimal oversight. Technical competency required to manage laboratory systems.
Ability to write interpret and critique technical specifications and related documentation with little assistance.
Skills:
Demonstrate advanced proficiency in the use of computers including word processing and spreadsheets.
Demonstrated ability to drive continuous improvement and drive change
Highly effective written verbal and interpersonal skills.
Proven ability to accomplish advanced technical tasks both independently and as a member of a research team.
Ability to sit or stand for long periods of time.
Work in a laboratory environment and adhere to safety requirements
Education/Experience:
Minimum of a bachelors degree and minimum of 13 years of independent experience designing and developing LCMS/MS. A proven track record of LCMS/MS method development is required.
Additional Sills: