RCI-QD-9419-1 LC-MS/MS Method Development Scientist - Lenexa, KS

Day Shift (roughly 8-5 with flexibility), M-F generally

Sometimes OT or Weekend work may be needed/allowed.

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 large-scale 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 company-owned laboratory notebooks for all staff members involved in medium to large-scale projects.
• Periodically reviews and co-signs 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 large-scale projects. Leads project staff towards new developments in technical expertise.
• Assist in preparing technical SOPs, assay validation reports, and other assay-related documentation for medium to large-scale 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 day-to-day issues and achieve results.
• Drives compliance with industry regulatory and quality standards for Assay Design Control processes.

Knowledge:

• Ability to design and develop LC-MS/MS-based 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 LC-MS/MS data to generate accurate and reliable results.
• Maintain and troubleshoot LC-MS/MS instrumentation and software with little assistance.
• Ability to lead a mass spectrometry-based 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 bachelor’s degree and minimum of 1-3 years of independent experience designing and developing LC-MS/MS.
• A proven track record of LC-MS/MS method development is required.