Full-Time

Chromatography Data Reviewer

Confirmed live in the last 24 hours

Arrowhead Pharmaceuticals

201-500 employees

Develops RNAi-based therapies for diseases

Biotechnology

Junior, Mid, Senior

Fitchburg, WI, USA

Required Skills

Communications

Requirements

Bachelor's degree or equivalent experience
Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
Thorough knowledge of standard pharmaceutical testing, especially analysis by chromatography, and divisional SOPs
Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
Strong verbal and written communication skills
Strong attention to detail
Ability to independently review laboratory reports as well as analytical methods and test results
Ability to deal with multiple and changing priorities
Ability to provide clear and concise feedback and/or documentation of results
Ability to work in a collaborative team environment

Responsibilities

Evaluates laboratory data for compliance with analytical methods, specifications, and SOPs
Reviews sample results for completeness and accurate representation of the data and report findings
Communicates with laboratory staff to proactively address the quality of laboratory documentation
Prepares statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the project leader for correction
Conducts SOP review and writing. Conducts consultations for quality records
Performs other duties as assigned

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Chromatography Data Reviewer will monitor the quality of laboratory data and reports and review analytical testing data and related notebooks as specified by Standard Operating Procedures (SOPs). This position will evaluate data to ensure compliance with analytical methods, specifications, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).

Responsibilities

Evaluates laboratory data for compliance with analytical methods, specifications, and SOPs
Reviews sample results for completeness and accurate representation of the data and report findings
Communicates with laboratory staff to proactively address the quality of laboratory documentation
Prepares statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the project leader for correction
Conducts SOP review and writing. Conducts consultations for quality records
Performs other duties as assigned

Requirements:

Bachelor’s degree or equivalent experience
Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
Thorough knowledge of standard pharmaceutical testing, especially analysis by chromatography, and divisional SOPs
Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
Strong verbal and written communication skills
Strong attention to detail
Ability to independently review laboratory reports as well as analytical methods and test results
Ability to deal with multiple and changing priorities
Ability to provide clear and concise feedback and/or documentation of results
Ability to work in a collaborative team environment

Wisconsin pay range

$65,000—$90,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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Arrowhead Pharmaceuticals

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Arrowhead Pharmaceuticals specializes in developing RNAi-based therapies using their TRiM platform, which leverages various RNA chemistries for tissue-specific targeting, enabling rapid and durable knockdown of disease-causing genes. The TRiM platform also utilizes ligand-mediated delivery, offering potential advantages such as simplified manufacturing, reduced costs, and improved safety.

Company Stage

IPO

Total Funding

$899.9M

Headquarters

Pasadena, California

Founded

2004

Growth & Insights

Headcount

6 month growth

↑ 9%

1 year growth

↑ 27%

2 year growth

↑ 63%