The Position 

This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. An Associate Scientist I will support method development/validation activities for new drug substances and drug product. He/She will also support testing required for GLP Toxicology an cGMP Clinical Trial material release, as well as stability studies. This position reports to either AD Management, or Senior AD staff.

Responsibilities 

• Know and adhere to cGMP policies and procedures and relevant SOPs
• Work closely with team members to provide accurate analytical results in support of new and on-going projects
• Work with supervision to meet project timelines and deliverables
• Perform testing of samples to support batch release and stability studies
• Learn and 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
• Train and participate in evaluation and interpretation of scientific data and provide the significance of such
• Assist in the design and execution of routine experiments
• Participate in analysis of data/results and interpret outcome of experiments and assist in determining appropriate follow-up
• Compile data tables of results and certificate of analysis, develop stability reports
• Calibrate, maintain, and troubleshoot simple analytical equipment
• Other duties as assigned

Requirements:

• B.S. in Chemistry (or related area of study)
• Entry level with 1-3 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
• Can be flexible with changing priorities