Associate Scientist, CMC Analytical Development

The Position

This position is part of the Analytical Development (AD) group within the CMC Manufacturing organization. The Associate Scientist III will support method development and validation activities for new drug substances and drug products. This role will also contribute to testing for GLP toxicology studies, cGMP clinical trial material release, and stability studies. The position reports to AD management.

Responsibilities

• Know and adhere to cGMP policies and procedures and relevant SOPs
• Independently provide accurate analytical results in support of new and on-going projects
• Independently meet project timelines and deliverables
• Perform testing of samples to support batch release and stability studies
• Perform portions of analytical techniques, such as HPLC, GC, FTIR, UV/Vis, LC/MS, KF, etc.
• Assist with the design and initiation for development of analytical methods and improvement of existing ones to support all stages of drug development process
• Handle, analyze and characterize chemicals, pharmaceuticals, and related organic molecules
• Evaluate and interpret scientific data and provide the significance of such
• Independently design and execute non-routine experiments
• Analyze data/results and interpret outcome of experiments and independently propose appropriate follow-up
• Compile data tables of results, certificate of analysis, and develop stability reports
• Write analytical test methods, protocols, and standard operating procedures
• Calibrate, maintain, and troubleshoot all analytical equipment
• Other duties as assigned

Requirements:

• BS or M.S. in Chemistry (or related area of study)
• 4 years of experience working in a chemistry laboratory setting.
• Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices.
• Ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up.
• Strong attention to detail.
• Works well with others and in a team environment