Associate Scientist III, CMC Analytical Development

CHEManager International; Verona (WI); On-site; USD 78,000 - 90,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Wisconsin seeks an Associate Scientist III to support method development and validation for drug substances and products within the Analytical Development group. The role also supports GLP toxicology testing and cGMP batch release, as well as stability studies.

You will perform data analysis, interpret results, and work with HPLC, GC, FTIR, UV/Vis, LC/MS, and KF. A Bachelor’s in Chemistry and 4 years of laboratory experience are required; a Master’s is

Qualifications

• Bachelor's in Chemistry (or related area of study).
• 4 years of experience in a chemistry laboratory setting.
• Familiar with analytical instrumentation, test methodologies/ validations, data acquisition systems, and cGMP policies and practices.
• Ability to 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.

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.

Skills

Analytical data interpretation

Attention to detail

Team collaboration

Adaptability

Education

Bachelor's in Chemistry

Master's Degree

Tools

HPLC

GC

FTIR

UV/Vis

LC/MS

KF

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

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. This position reports to either AD Management, or Senior AD staff.

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

Requirements

• Bachelor'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
• Can be flexible with changing priorities

Preferred

• Masters Degree

Wisconsin pay range

$78,000-$90,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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