Quality
Project Coordinator II, Stability Quality Control
Office Location: Verona, Wisconsin, United States
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
The Stability Coordinator is responsible for assisting in the oversight and management of Arrowhead’s stability program. Key responsibilities of this position include preparing stability samples for study initiation, tracking timepoint pull dates, performing sample pulls, and maintaining testing data forms and reports. The Stability Coordinator will provide study documentation oversight to ensure that study reports are complete and accurate. This position will communicate with contract vendors to coordinate analytical testing and sample storage and is responsible for the reconciliation and disposition of stability samples upon completion of studies.
Responsibilities
- Work cross-functionally with Manufacturing to ensure release and stability samples are received and transferred to the appropriate testing lab(s).
- Authoring, review, and revision of Stability documents including protocols, work instructions, and Stability reports, as needed.
- Perform stability study initiations.
- Assist in maintaining stability timepoint pull schedules and perform timepoint sample pulls.
- Management of samples including reconciliation of inventory, sample location, and distribution of samples to testing lab(s).
- Maintain communication with external testing laboratories or storage facilities to coordinate shipments and sample analyses.
- 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 for internal and external stability studies.
- Help Ensure that reported stability testing results are complete, accurate, and documented per ALOCOA++ standards.
- Assist in the set down and management of internal and external retain and reserve samples.
- Work cross-functionally to provide oversight of stability processes and improvements.
- Other duties, as needed.
Requirements
- Bachelor’s degree in Chemistry (or related scientific field) with 2+ years’ relevant experience (pharmaceutical CMO/CRO).
- Experience with MS programs including Excel, Word, and PowerPoint.
- Strong verbal and written communication skills and ability to work in a cross-functional 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.
Candidates must have current, valid authorization to work in the country where this role is located.