Scientist - LCMS

• 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 development execution of routine methods/assays under moderate supervision.
• May contribute to technical discussions, experimental design, data review, sponsor inquiries.
• 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 area of expertise.
• May support the team in the absence of the line manager.
• Exercise good judgment in assessing whether analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances through routine data analysis.;
• Identify abnormal progress of test procedure, potential quality failures, or otherwise unusual results and escalate to senior lab personnel immediately.
• Prepare data analysis results for upload to LIMS system under the guidance of senior level staff.
• 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.

• Basic knowledge of method development and analytical techniques for assigned technical area 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.
• LC-MS/MS experience is required; preferably including method development experience.
• 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.
• Proficiency with data analysis techniques and calculations.
• 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 co-workers, managers, and clients.
• Ability to maintain a degree of independence to complete assigned tasks and projects.

IQVIA