Research Scientist I

About the role

A Research Scientist I functioning in the role of Method Developer within these disciplines is responsible for execution of complex method development and validation studies utilizing appropriate laboratory instrumentation and software. They are also responsible for performing data analysis and providing accurate summaries of method development experiments. All procedures will be performed and documented in compliance of regulatory standards. They understand the necessary compliance to ensure quality data is produced as well as understand the regulatory and GxP requirements and industry standards within their discipline. The Research Scientist I is responsible for ensuring the scientific integrity of their studies, meeting study timelines, and maintaining active communication/collaboration. They can recognize and communicate method and data issues on study. They will assist laboratory investigations and process improvement initiatives as needed.

Responsibilities

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Execute review and approval of data with oversight for final scientific/technical decisions within a single operational area
• Effectively demonstrate the behaviors and performance characteristics as described in the CRL DNA
• Demonstrate effective communication skills through both informal and formal discussions with peers, supervisor, team and across the organization
• Actively communicate and effectively collaborate across operational areas in order to adhere to timelines and produce quality data
• Assist with the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues with minimal oversight
• Independently and efficiently develop and validate quantitative/qualitative methods/procedures with increased complexity/scope in one operational area with minimal oversight
• Independently and accurately perform data analysis in appropriate software for a majority of analytical platforms within an operational area
• Independently and efficiently operate laboratory instruments including their respective software applications for 1-2 analytical platforms within an operational area
• Develop and maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas
• Demonstrated ability to independently recognize method and/or data issues and communicate them to management to minimize study impact
• Independently prepare accurate summaries of method development data
• Independently and accurately write both study and non-study deviations
• Develop and maintain understanding of regulatory and GXP requirements, industry standards and company SOPs within one operational area
• Effectively assist in leading the lab staff in the completion of method validation studies as required by operational area
• Provide support to staff members as required by operational area as needed
• Actively participate in internal process improvements, presentations and harmonization efforts
• The development and enforcement of a robust LCMS instrument schedule
• Liaising between the lab and its metrology and service vendor partners
• Training and development of junior staff on the LCMS systems
• Leveraging scientific expertise to improve study investigations and build knowledge within the laboratory

Requirements

• Education: Bachelor’s degree (BA/BS) with 5-7 years of relevant working experience. Master’s degree (MS) with 1-2 years of relevant work experience. Doctorate degree (PhD) with no experience.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.

Job Details

Minimum Qualifications: Education: Bachelor’s degree (BA/BS) with 5-7 years of relevant working experience. Master’s degree (MS) with 1-2 years of relevant work experience. Doctorate degree (PhD) with no experience.

Other: Ability to communicate verbally and in writing at all levels inside and outside the organization. Basic familiarity with Microsoft Office Suite. Computer skills, commensurate with Essential Functions, including the ability to learn a validated system. Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice. Ability to work under specific time constraints.

Workplace Requirements: While performing the duties of this job, the employee must be able to perform general office and/or laboratory procedures, which require, talking, hearing, standing, or sitting for long periods of time, typing/entering data into a computer, using appropriate instruments, reaching with hands and arms, and wearing safety equipment (PPE) according to OSHA regulations and company standards. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus. General office working conditions, the noise level in the work environment is usually quiet.

The pay for this role is $95k/year.