Scientist/Sr. Scientist, CMC Analytical Development - Arrowhead Pharmaceuticals
Verona, WI
About the Job
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
This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. The Scientist/Sr. Scientist will support method development/validation activities for new drug substances and drug products. He/She will also support testing required for drug substance and drug product process development, characterization of impurities, and other activities associated with GLP Toxicology and cGMP Clinical Trial materials.
Responsibilities
- Know and adhere to Arrowhead Core Values, cGMP policies and procedures and relevant SOPs
- Provide accurate analytical results in support of new and on-going projects
- Work independently and with project teams to meet and lead project timelines and deliverables
- Provide leadership, technical guidance, and development to junior scientists
- Serve as Analytical Project Coordinator or Lead for on-going or new projects and take ownership of analytical requirements needed, including scheduling, prioritizing and coordinating analytical testing
- Prepare technical reports, presentations, SOPs, and policies and procedures
- Independently design and initiate development of analytical methods and improvement of existing ones, to support all stages of API (active pharmaceutical ingredient) and drug product development
- Apply advanced scientific principles, theories and concepts to a broad range of research problems and develop innovative solutions for analytical problems related to drug substances and/or drug products in compliance with appropriate Standard Operating Procedures (SOPs) and regulatory guidelines
- Develop specifications and test methods for raw materials, in-process and isolated intermediates, as well as drug products
- Design and execute non-routine experiments
- Analyze and interpret data/results and outcome of experiments and propose appropriate follow-up
- Write project documentation (Analytical test methods, developmental reports, validation reports, and protocols) of higher complexity
- Collaborate with other groups and activities necessary to ensure project deliverables are met
- Perform peer review of notebooks, protocols, and validation documentation
- Draft Out of Specification and Deviations documents
- Perform testing of test samples in support of API and drug development
- Calibrate, maintain, and troubleshoot all analytical equipment
- May perform release testing of raw materials, stability study samples, method validation, and method transfer activities for toxicology and clinical trial activities when needed
- Other duties as assigned
Requirements:
- Ph.D. in Chemistry (or related field) with 0-5 years of relevant experience, M.S. in Chemistry (or related field) with at least 10 years of relevant experience, or B.S in Chemistry (or related field) with at least 14 years of relevant experience., UV/Vis, LC/MS, KF, etc.
- Expertise in method development and validations in support of drug substance and drug product development, and manufacture
- Skills and knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals and related organic molecules
- Expertise with analytical instrumentation, and test methodology/validations
- Knowledgeable with data acquisition systems, and cGMP policies and practices
- Demonstrated experience with analytical instrumentation theory and practice as well as pharmaceutical drug substance and drug product development and processes
- Has a solid understanding of CMC regulatory requirements for pharmaceutical products
- 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.
All applicants must have authorization to work in the US for a company.