Research Scientist

Job Summary

We are seeking a Research Scientist 1 for our Bioanalytical Chemistry Team in Mattawan MI.

Bioanalytical Chemistry supports the evaluations of test compounds by providing bioanalytical quantitative analysis of drug in body fluids and tissues from non-regulated and regulated studies including preclinical safety evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials. Staff participate in the development and validation of quantitative LC/MS/MS methodology, sample analysis, and interpretation and reporting of data utilizing validated hardware and software systems. This includes the development of sample extraction techniques, rapid LC separations, and employment of laboratory robotics to enhance delivery time of bioanalytical data. Staff are also knowledgeable in the application of GxP’s and applicable SOPs, along with adhering to study protocols to accurately document methods, procedures, and results for inclusion into study reports and regulatory documents.

Essential Functions:

• Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with minimal oversight
• Execute review and approval of data with minimal oversight for final scientific/technical decisions within a single operational area
• Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with minimal oversight
• Assist with minimal oversight the completion of laboratory investigations, assay troubleshooting and quality observations
• Independently assist in problem solving for technical and/or regulatory issues • Responsible for review of study plans/protocols/amendments
• Participate in Sponsor visits/tours with minimal oversight • Provide expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area
• Independently perform data analysis using appropriate software
• Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
• Independently function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD
• Independently ensure scientific integrity of studies
• Independently function as a Principal Investigator, Individual Scientist and/or Study Director
• Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Write, review and approve deviations with minimal oversight
• Full understanding of regulatory and GXP requirements, industry standards and company SOPs within one operational area
• Effectively manage a small portfolio of research projects including method development and validation while ensuring timelines are met in a single operational area with minimal oversight
• Understand the theory and application of correction factors with oversight as required by operational area
• Able to recognize method and/or data issues and communicate them to management to minimize study impact with minimal oversight
• Provide support to staff members as required by operational area as needed
• Actively participate in internal process improvements, presentations and harmonization efforts
• Performs all other related duties as assigned

Job Qualifications

• Bachelor’s degree (BA/BS) with 7-9 years of relevant working experience. Master’s degree (MS) with 3-4 years of relevant working experience. Doctorate degree (PhD) with 1-2 years of relevant working experience.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• 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.

The pay range for this position is $95,000 to $105,000 annually USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Competencies