Job Summary

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 

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Actively communicate and 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
• Effectively develop and validate quantitative/qualitative methods/procedures with increased complexity/scope in one operational area with minimal oversight
• Independently perform data analysis in appropriate software for a majority of analytical platforms within an operational area
• Independently operate laboratory instruments including their respective software applications for 1-2 analytical platforms within an operational platform
• 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
• Able to recognize method and/or data issues and communicate them to management to minimize study impact independently
• Independently prepare summary of method development data
• Write both study and non-study deviations with minimal oversight
• Full understanding of regulatory and GXP requirements, industry standards and company SOPs within one operational area
• Independently lead the lab staff in the completion of method validation studies
• 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
• Industry & GLP Experience Required
• 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 $70-90k/year.  Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.