Work Schedule

Environmental Conditions

Job Description

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

• 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.
• Prepares study protocols, project status reports, final study reports and other project-related technical documents.
• Reviews, interprets and analyzes data for technical, quality and compliance to protocols, methods and SOPs.
• Communicates data and technical issues to the client and responds to client needs and questions.
• Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.
• Assists with quality systems and new equipment.
• Assists in method development or method transfer.

Education/Experience

• 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.
• 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

• Solid understanding and knowledge of general chemistry and separation science.
• Full understanding of laboratory requirements LC-MS/MS systems, SOPs, ICH guidelines, EMA requirements and FDA guidance.
• Ability to utilize Microsoft Excel and Word to perform tasks
• Proven problem solving and troubleshooting abilities
• Effective oral and written English communication skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team