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Scientist, ADME Sciences

Aplica ya
Mapa de ubicación: Indianapolis, Indiana, United States Full time R1319758

Descripción del trabajo

Responsible for performing a variety of technical procedures and experimental execution in support of bioanalytical needs for In Vitro Metabolism studies.  Will require sample analysis, method development, and validation of analytical methods for small molecules. 

RESPONSIBILITIES:

  • Responsible for performing and documenting analytical procedures in accordance with company procedures and regulatory guidelines. Complete and prepare documentation in compliance with regulatory and corporate guidelines.
  • May be responsible for contributing to the design and execution of routine bioanalytical methods/assays under moderate supervision.
  • May contribute to technical discussions, experimental design, data review, sponsor inquiries related to LC/MS/MS analysis.
  • Assist in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times.
  • May lead a laboratory or cross functional project and assist with implementation.
  • Act as a technical resource for laboratory staff in bioanalytical procedures and execution of LC/MS/MS methods.
  • May support the team in the absence of the line manager. 
  • Exercise good judgment in assessing whether an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances through routine analysis.
  • Identify abnormal progress of test procedure, potential quality failures, or otherwise unusual results and escalate to senior lab personnel immediately.
  • Prepare data outputs for analysis by wet lab scientists.
  • Preparation of buffers and solutions for analysis, as required.
  • Perform and document calibration and maintenance of laboratory equipment as assigned.
  • Perform and document hands-on training for other lab personnel in areas of proven competency as assigned.
  • Participate in continuing education through self-study, attending training sessions and lectures and meetings.
  • Production of quality data and documentation in adherence to timelines in accordance with regulatory requirements.
  • Support safety and 6S requirements and initiatives.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

  • Bachelor's Degree in Biology, Chemistry, or similar field OR
  • Master’s degree or equivalent combination of education, training, and experience.
  • 3-5 years of related experience in method development or specific methodology area.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

  • Basic knowledge of method development and analytical techniques for small molecule drug development including principles, theories, concepts, and instrumentation, typically obtained through advanced education.
  • Understanding of sample handling and preparation.
  • General awareness of the drug development process and the interaction of method development in that process.
  • Working knowledge of regulatory agency standards within the area of responsibility.
  • Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
  • Strong technical knowledge of complex analytical techniques and science supporting the analysis.
  • Ability to troubleshoot laboratory equipment and resolve process issues.
  • Good computer skills including proficiency with Microsoft Excel, PowerPoint, and Word.
  • Effective organizational and interpersonal skills.
  • Effective communication and presentation skills.
  • Capable of handling multiple tasks simultaneously.
  • Strong attention to detail and accuracy.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Ability to maintain a degree of independence to complete assigned tasks and projects.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

Aplica ya

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