Purpose
Performs complex laboratory analysis of pharmaceutical products and proficiently uses LC-MS/MS systems, analyzes samples, calculates and analyzes data and records data in adherence with SOP's and the industry.
Major Job Responsibilities
61 Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds with LC-MS/MS systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision.
61 Prepares study protocols, project status reports, final study reports and other project-related technical documents.
61 Reviews, interprets and analyzes data for technical, quality and compliance to protocols, methods and SOPs.
61 Communicates data and technical issues to the client and responds to client needs and questions.
61 Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.
61 Assists with quality systems and new equipment.
61 Assists in method development or method transfer.
Education/Experience
61 Bachelor's degree in Chemistry or related field with 2-3 years of experience in an analytical testing laboratory with LC-MS/MS. Pre-clinical GLP TK or clinical PK bioanalysis with LC-MS/MS in CRO experience is preferred.
61 LC-MS/MS bioanalysis method development experience in GLP or Non-GLP environment for pre-clinical or clinical studies is preferred.
Knowledge, Skills and Abilities Required
61 Solid understanding and knowledge of general chemistry and separation science.
61 Full understanding of laboratory requirements LC-MS/MS systems, SOPs, ICH guidelines, EMA requirements and FDA guidance.
61 Ability to utilize Microsoft Excel and Word to perform tasks
61 Proven problem solving and troubleshooting abilities
61 Effective oral and written English communication skills
61 Time management and project management skills
61 Ability to work in a collaborative work environment with a team