Associate Scientist II, CMC Analytical Development
Arrowhead Pharmaceuticals
17 days ago
On-site
Madison, WI
Operations
The Position
This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. An Associate Scientist II will support method development/validation activities for new drug substances and drug product, including 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
- Provide accurate analytical results in support of new and on-going 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 design and initiation of analytical methods development and improvement
- Handle, analyze, and characterize chemicals, pharmaceuticals, and related organic molecules
- Evaluate and interpret scientific data (with supervision)
- Assist in the design and execution of non-routine experiments
- Analyze data/results, interpret outcomes, and propose follow-up for straightforward studies
- Compile data tables, certificate of analysis, and develop stability reports
- Write analytical test methods and protocols
- Calibrate, maintain, and troubleshoot simple and some complex analytical equipment
- Other duties as assigned
Requirements:
- B.S. in Chemistry (or related area of study)
- At least 3 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 and interpret data and propose follow-up
- Strong attention to detail
- Works well with others in a team environment
- Flexible with changing priorities
Benefits:
- Competitive salaries and an excellent benefit package
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.
This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. An Associate Scientist II will support method development/validation activities for new drug substances and drug product, including 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
- Provide accurate analytical results in support of new and on-going 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 design and initiation of analytical methods development and improvement
- Handle, analyze, and characterize chemicals, pharmaceuticals, and related organic molecules
- Evaluate and interpret scientific data (with supervision)
- Assist in the design and execution of non-routine experiments
- Analyze data/results, interpret outcomes, and propose follow-up for straightforward studies
- Compile data tables, certificate of analysis, and develop stability reports
- Write analytical test methods and protocols
- Calibrate, maintain, and troubleshoot simple and some complex analytical equipment
- Other duties as assigned
Requirements:
- B.S. in Chemistry (or related area of study)
- At least 3 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 and interpret data and propose follow-up
- Strong attention to detail
- Works well with others in a team environment
- Flexible with changing priorities
Benefits:
- Competitive salaries and an excellent benefit package
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.