About this role
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as an Associate Research Scientist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
Purpose
Performs complex laboratory analysis and method R&D 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.
- Deep insight in method development.
Education/Experience
- Bachelor's degree in Chemistry or related field with over 5 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