Senior Writer, CMC Process Development

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 Senior Writer works in the Chemistry, Manufacturing, and Controls Group focusing on the technical documentation for process validation and other aspects of small-molecule and macromolecule process development. There is a particular emphasis on group data review and technical report generation and maintenance. This is an ideal position for an individual with an organic chemistry or pharmaceutical background who has an interest in projects related to novel technology in synthesis, purification and characterization of oligonucleotides and bioconjugates, with a focus on process validation.

Responsibilities

• Prepare and maintain Process Development technical reports, characterization reports, presentations, SOPs, and policies and procedures
• Serve as the group lead for characterization and validation technical data and notebook review
• Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings
• Work independently or with senior scientists to develop statistical synthetic approaches to desired compounds while keeping an eye toward large-scale synthesis and process validation
• Lead and collaborate with unit operation characterization efforts of small molecules and macromolecules with a focus on developing robust procedures
• Collaborate with other scientists in the group to prepare complex organic constructs
• Interpret analytical data pertaining to small-molecule and macromolecule targets
• Begin providing recommendations to troubleshoot experiments
• Maintain a well-documented laboratory notebook
• Analyze experimental data with statistical software and discuss appropriate follow-up with supervisor
• Mentor and coach team members, promoting a culture of continuous learning and improvement

Requirements{{:}}

• Ph.D. with at least 2 years, M.S. with at least 7 years, or B.S. with at least 10 years of relevant industrial or academic experience, in Chemistry or related field
• Proficiency with Microsoft Office
• Experience with synthetic organic chemistry
• Excellent verbal and written communication skills
• Strong problem-solving skills
• Strong attention to detail
• Can perform tasks assigned with minimal supervision

Preferred{{:}} 

• Experience working with both small molecule or large molecule synthetic targets either in an academic or industrial setting
• Prior experience with regulatory writing and filings
• Prior experience and familiarity with GLP/GMP regulations and process validation
• Experience with small-molecule or macromolecule analytical techniques (e.g., HPLC, UV-Vis spectrophotometry, mass spectrometry, etc.)
• Experience with JMP or similar statistical analysis software
• Be able to perform complex math functions and be able to draw and interpret graphs and charts

Wisconsin pay range {{:}} $120,000 USD - $140,000 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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