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 8+ years of relevant laboratory experience, or B.S in Chemistry (or related field) with at least 12 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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Skills Required
- Bachelor's in Chemistry or related discipline with 8+ years lab experience OR Master's with 5+ years
- Fully knowledgeable of cGMP and ICH laboratory requirements and operations
- Prior experience testing oligonucleotides, peptides, or other synthetic biomolecules
- Hands-on experience with LCMS, AEX-HPLC, RP-HPLC/UHPLC, Karl Fischer titration, or LAL/endotoxin testing
- Experience supporting in-process (real-time) testing in a manufacturing-adjacent QC lab
- Experience with analytical method validation, method transfer, and QC testing
- Proficient with analytical instrumentation, test methodology/validations/transfers, and data acquisition systems
- Strong attention to detail and good documentation practices; ability to meet hold times and turnaround targets
- Ability to lead investigations, mentor junior scientists, and drive technical decision-making
What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients. Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety. Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline. Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations. Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
