Work Schedule

Environmental Conditions

Job Description

Major Job Responsibilities:

Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with SOP's and the industry. Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.

• Independently performs method development, method validations, and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery 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 instruments and analytical problems.

• Assists with quality systems and new equipment.

• Assists in designing method validation or method development protocols and establish project timelines.

Education/Experience:

• Bachelor's degree in Chemistry or related field with more than 6 years of experience in an analytical testing laboratory with LC-MS. Pre-clinical GLP TK or clinical PK bioanalysis with LC-MS in CRO experience is preferred.

• LC-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, SOPs, ICH guidelines

• Proficiency on technical operating systems

• Proven problem solving and troubleshooting abilities

• Effective oral and written communication skills

• Proven ability in technical writing skills

• Time management and project management skills

• Ability to work in a collaborative work environment with a team

• Proven problem solving and troubleshooting abilities