Senior Associate Scientist

Location: Mattawan

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform.

In return, we'll help you build a career that you can feel passionate about.

** Job Overview*
* 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.

Essential Duties and 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 demonstrates 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.

+ 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 efficiency 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.

** Job Requirements*
* Minimum Qualifications:

+ 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

+ 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…