Team Lead, Quality Control (In-Process Controls & Validations)

Job Description

Job Description

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 & 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 falls within the Quality Control structure, under the Quality Assurance Organization. The Team Leader, IPCs & Validations will manage chemists and help to support the analytical testing of pharmaceutical in­ process manufacturing samples, and validation (analytical methods and computer systems) activities for drug substances and drug products while carrying out a supervisory function. They will work cross-functionally to identity and resolve any issues that arise. They will have the opportunity to hold leadership functions for project support personnel.

The Team Leader IPCs & Validations will manage, and support testing required. The Team Leader is expected to be proficient in analytical techniques and capable of making independent scientific decisions. They will assist in the drafting and maintenance of study documents (testing directives, methods, reports) and manage deadlines. The position also requires the ability to lead and mentor chemists who are new to the industry. This position reports to QC Laboratory Senior Management.

Responsibilities

• Management

Provide leadership and guidance to a team of QC chemists, ensuring their professional growth and development.

Fully knowledgeable of cGMP requirements and ICH guidelines

Must be able to work with people at various levels of the organization. Must have basic knowledge of computers and PC's. Ability to use windows-based software including MS Office and chromatography data collection software.

Requirements :

Wisconsin pay range

$85,000—$100,000 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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