Sr. Scientist II LCMS

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Effectively demonstrates behaviors and performance characteristics as described in our core values
• Demonstrates full understanding of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and apply as required by operational area
• Demonstrates effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, across the organization, and externally with Regulators and Sponsors
• Maintain and demonstrate critical thinking, troubleshooting and time management skills aligned with the needs of the operational area
• Ensures that operational area is clean and inspection ready at all times
• Independently and efficiently execute the completion of laboratory investigations, assay and equipment troubleshooting, and quality observations. Effectively act as a technical resource for troubleshooting activities
• Independently and accurately prepare reagents, standards and control samples
• Independently and accurately perform laboratory support functions such as labeling, monitoring expiration dates, and solution preparation
• Independently and accurately execute routine sample analysis studies with increased throughput and workload
• Independently operate and maintain analytical instruments as required by operational area
• Independently and accurately perform data analysis in appropriate software for a majority of analytical platforms
• Demonstrates a complete understanding of what constitutes a passing or failed run
• Demonstrated ability to independently recognize method and/or data issues, communicate them to management, and propose solutions to minimize study impact
• Independently and accurately executes method validation and qualification projects with increased workload as required by operational area
• Independently designs and accurately executes complex method development projects as required by operational area
• Independently prepare accurate summaries of method development data
• Demonstrates a complete understanding of compliance and regulations by independently and accurately writing both study and non-study deviations
• Independently and effectively function as a liaison, maintaining timely and frequent communication with the Sponsor as required by operational area
• Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
• Independently ensure the scientific integrity of studies as required by operational area
• Maintains an awareness of team workload and routinely provides support to other staff members
• Independently and effectively review laboratory documents and notebooks (e.g., plans, experiment/sample runs, validation files, reports, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations as required by operational area. Independently and accurately review system audit trails as required by operational area as needed
• Effectively lead internal process improvements, presentations and harmonization efforts
• Actively looks for suitable opportunities to publish or present work, both internally and externally
• Effectively assist in the training of new staff members for all functions as required by operational area as needed
• Effectively assists in the review of proposals and highlights any concerns to Management and/or Business Development as required by operational area as needed
• BA/BS or higher with 7+ years lab experience; all experiences will be evaluated
• Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
• Able to independently perform complex lab work
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document clearly

Performs and leads complex lab work, sample analysis, validation, and method development with limited supervision.