Job Summary:

Independently analyzes biological or chemical samples for various compounds and components in compliance with standard operating procedures (SOPs) and regulatory agency guidelines. Provides support for a variety of studies utilizing a wide range of analytical techniques and procedures while working with minimal supervision.

Essential Job Duties:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

• Independently organizes and conducts routine analyses of samples in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines.
• Capable of complex analyses using new methods/technology, with scientific guidance as needed.
• Documents work, maintains study documentation and laboratory records according to appropriate regulatory documentation practices. Also can perform QC review of data.
• Independently operates laboratory equipment, including system set up and general maintenance as directed by SOP (LC-MS/MS). Capable of problem identification and issue resolution relating to equipment repair and submits work orders or maintenance requests as appropriate.
• May provide input and participate in project meetings. This can include planning, monitoring, and guiding project work by effectively utilizing personnel and resources for timely completion of assigned projects.
• Informs Study Director, Lead Scientist, and/or management of any problems or deviations that may affect integrity of the data; participates in corrective action of problems.
• Contributes to a cohesive team environment. Plans individual assigned workload on a daily basis in coordination with team members, can effectively manage multiple assignments.
• Identifies technical issues and proactively communicates them to the study team. Is capable of performing troubleshooting experiments and is an active participant in the design of troubleshooting experiments.
• Provides ideas, supports, and participates in process improvement initiatives.
• Maintains a clean and safe laboratory work environment. Demonstrates understanding of Health and Safety compliance by ensuring that policies/SOPs and training are up to date.
• Contributes to Policy, SOP, or guide writing and revising through peer review.
• May be considered a SME in applicable areas for sample analysis, laboratory, or site processes
• May train, mentor, or assist less experienced staff.
• Participates in client visits and communicates method related or technical information as needed
• Performs other related duties as assigned

• Bachelor's degree and at least 4 years related or relevant laboratory experience or master's degree and at least 2 years of related or relevant laboratory experience.
• Experience with the use of standard laboratory equipment (e.g., balances, pipettes, centrifuges).
• Experience with use and troubleshooting analytical instrumentation (UPLC, HPLC, Mass Spectrometry) and LIMS.
• Effective communication (verbal and written), presentation and interpersonal skills.
• Knowledgeable on a variety of study types, analysis procedures, and methodologies.

• Bachelor's degree or master's degree of Science/Arts in Chemistry, Biology, or related scientific field plus minimum required experience.
• Relevant laboratory experience may be substituted for education. Bioanalytical experience is preferred.
• Ability to perform advanced computer skills (e.g., Word, Excel