Quality & Compliance
Quality Control, Stability Project Coordinator
Office Location: Verona, WI
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 Stability Coordinator will assist in coordinating stability studies, drafting study documentation, preparing stability samples for study initiation, tracking pull dates, and maintain stability data and reports. The Stability Coordinator will identify and retrieve samples as required per stability schedules and assist with shipping and receiving of stability samples as needed.
The ideal candidate will have experience evaluating and maintaining stability data. The Stability Coordinator will maintain folder creation, document filing, and study reports. The Stability Coordinator is also responsible for the reconciliation and disposition of stability samples upon completion of studies.
Responsibilities
- Authoring, review, and revision of Stability documents including protocols, work instructions, and Stability reports.
- Assist in the set down and management of internal and external retains and reserve samples.
- Stability study initiation, coordination, tracking, and sample management, including sample storage in stability chambers and distribution of samples to testing lab(s).
- Assist in the setup and tracking of monthly stability timepoint pulls.
- Assist in routine maintenance of stability chambers.
- Assist in the management of stability program data and reports, maintain program study folders, and compile and interpret data.
- Help Ensure that the stability testing results reported are valid, accurate, and documented per applicable regulatory requirements.
- Other duties, as needed.
Requirements:
- Bachelor’s degree in Chemistry (or related scientific field) with 1-2 years’ relevant experience (pharmaceutical CMO/CRO).
- Experience with Excel, PowerPoint, and Word skills.
- Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment.
- Solid organizational skills with ability to adapt to changing priorities and deadlines.
Preferred:
- Knowledge of cGMP and cGLP guidelines for contract manufacturing and analytical laboratories and ICH/FDA guidance documents.
- Experience with stability programs and sample handling.
- LIMS system experience.
- Experience with Smartsheet, or similar.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.