Job Description
Job Overview
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 supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training and developing employees
- Develop organizational strength by hiring, identifying and developing personnel who are scientifically and/or technically strong
- Establish culture and atmosphere to maintain good retention and low turnover using available tools and metrics
- Assist with providing costing estimates for components of applicable studies
- Provide short- and long-term solutions that support continuous improvement
- Develop and maintain 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
- Ensure laboratory tasks and operations are executed in compliance with SOPs, protocols, regulatory requirements
- Establish and review Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures
- Develop and maintain contemporaneous knowledge of regulatory requirements
- Effectively plan, assign and direct work within one operational area with expanded scope and/or complexity
- Monitor performance metrics for operational area
- Function as a Principal Investigator, Individual Scientist, and/or Project Scientist as required by operational area or resourcing need
- Skillfully oversee the design, conduct, interpretation and reporting of studies
- Effectively utilize project management systems
- Lead implementation of new procedures and refinement of existing procedures to meet current and future business needs
- Performs all other related duties as assigned
Job Description
- Bachelor’s degree or equivalent with 8-10 years of relevant experience. Between 3-4 years of management experience required
- LCMS Experience Required
- CRO Experience Preferred
- 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
- Must be authorized to work in the United States without a sponsor visa, now or in the future.
The pay for this position is $90-95k/year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
Competencies
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.