The Position
This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. An Associate Scientist III will support method development/validation activities for new drug substances and drug product. They will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies.
Responsibilities:
- Know and adhere to cGMP policies and procedures and relevant SOPs
- Independently provide accurate analytical results in support of projects
- 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
- Handle, analyze and characterize chemicals, pharmaceuticals, and related organic molecules
- Evaluate and interpret scientific data and provide significance
- Independently design and execute non-routine experiments
- Analyze data/results and propose appropriate follow-up
- Compile data tables, certificate of analysis, and develop stability reports
- Write analytical test methods, protocols, and SOPs
- Calibrate, maintain, and troubleshoot analytical equipment
Requirements:
- Bachelorβs in Chemistry (or related area)
- 4 years of experience working in a chemistry laboratory setting
- Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies/practices
- Ability to analyze/interpret data and propose follow-up
- Strong attention to detail; team-oriented
- Flexibility with changing priorities