About this opportunity
Arrowhead Pharmaceuticals lists this Scientist II, Quality Control opportunity in madison, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
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 within the Quality Control structure, under the Quality Organization. Scientist II, Quality Control, will support the analytical method validation, method transfer and testing of pharmaceutical raw materials, in process manufacturing samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. Scientist II is expected to be proficient in several analytical techniques and will be capable of making independent scientific decisions. The position also requires the ability to lead and mentor co-workers. This position reports to QC Laboratory Management.
Responsibilities
Know and adhere to Arrowhead Core Values, cGMP policies and procedures and relevant SOPs
Work independently and with Analytical Development and manufacturing team to lead project timelines and deliverables.
Owns and leads scientific technical discussions and brainstorming sessions with internal and external stakeholders.
Guide junior scientists with technical guidance and training
Serve as Analytical Project Coordinator or coordinate for on-going or new Analytical Validation and technical transfer projects, take ownership of analytical requirements needed, and provide accurate analytical results
Prepare Analytical Validation technical reports, presentations, SOPs, and policies and procedures
Support analytical methods optimization and improvement of existing ones, to support all stages of API (active pharmaceutical ingredient) and drug product.
Ability to track/trend data and interpret degrative changes to the product on
Demonstrate proficiency with various related analytical techniques, such as LCMS, HPLC/UPHPLC, GC, FTIR, UV/Vis, KF.
Design and execute non-routine experiments.
Analyze data/results and interpret outcome of experiments and propose appropriate follow-up
Write project documentation (i.e. Analytical test methods, developmental reports and protocols)
Assist with drafting Out of Specification and Deviations with minimal supervision
Perform testing of test samples in support of API and drug release.
Performs technical data review on data acquired by other QC analysts as applicable
Other duties as assigned
Requirements
M.S. in Chemistry (or related field) with at least 5+ years of relevant laboratory experience, or B.S in Chemistry (or related field) with at least 8 years of laboratory experience.
Experience and working knowledge of various related analytical techniques, such as LCMS, HPLC/UHPLC, GC, FTIR, UV/Vis, LC/MS, KF, etc.
Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices
Skills and knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals and related organic molecules
Knowledgeable of cGMP, ICH, CDER requirements
Understanding of basic theories and principles of synthetic organic chemistry
Strong attention to detail.
Can perform tasks assigned with minimal supervision
Works well with others and in a team environment
Can be flexible with changing priorities
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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Worksite address
madison, WI, 53774, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.