Sr. Analytical Development Scientist
- Arrowhead Pharmaceuticals, Inc.
- Madison, Wisconsin
- Closing date
- Apr 16, 2023
- Field of specialization
- Work Function
- Job Type
- Full time
This R&D position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization and is at the key interface between Discovery and QC. The AD team develops and validates new analytical test methods in support of next generation RNA drug substance and drug product candidates. The candidate will support drug development activities through the development and validation of new analytical test methods, analytical investigations, impurity characterization, and analysis of early-stage raw materials, intermediates, drug substances and drug products associated with GLP Toxicology and cGMP Clinical Trial materials. He/She will work closely with Quality by providing support in technical training and guidance as well as a partner in collaborative investigations. This position is a laboratory position that reports into AD Management with a potential for future growth.
- Independently design and initiate development of new, scientifically sound analytical test methods
- Analyze and interpret data/results and outcome of experiments and propose appropriate follow-up studies, as relevant
- 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
- Independently develop and execute analytical method validation studies while assuring the study is phase appropriate (pre-clinical, Phase 1, Phase 2, Phase 3, commercial) and meets all cGMP, ICH and Regulatory standards
- Prepare technical reports, presentations, SOPs, policies and procedures of higher complexity
- Perform release testing of raw materials, intermediates, final products, and stability study samples for early phase toxicology and clinical trial activities
- Work collaboratively on intra- and inter-group teams to create project plans, timelines, and risk assessments to best assure the team’s ability to meet enterprise goals
- Construction of project scheduling, testing plan, status, challenges, risk assessment reports as well as presentations to management
- Develop specifications and test methods for raw materials, in-process and isolated intermediates, as well as drug substances and drug products
- Identify and promote new capital equipment and internal process improvements needs and implement plan to secure/deliver on approved projects
- Provide mentoring and technical guidance in support of early in career scientists
- Ph.D. in Chemistry (or related field) with 3+ years of relevant cGMP experience, M.S. in Chemistry (or related field) with 7+ years of relevant cGMP experience, or B.S in Chemistry (or related field) with 10+ years of relevant cGMP experience
- Expertise with analytical instrumentation, such as HPLC, GC, FTIR, UV/Vis, LC/MS, KF, etc.
- Expertise in the development and validation of phase appropriate (pre-clinical through to commercialization) analytical test methods in support of pharmaceutical raw materials, intermediates, drug substances and drug products
- Experience in common cGMP studies/investigations (e.g., Stability Study Trending, Out of Specification, Deviation, etc.)
- Skilled in the characterization of pharmaceutical drug candidates and related compounds (e.g., degradants and synthetic impurities)
- Solid understanding of Regulatory expectations and standards (e.g., cGPM, ICH, CDER, etc.)
- Experience is the support of Regulatory Filings (e.g., IMPD, NDA, etc.)
- Experienced in working collaboratively with cross-functional partners
- Experience with RNA Drug Substance and Drug Product
- Advanced degree in Chemistry (Synthetic Organic or Analytical)Demonstrated experience in technical leadership of analytical and/or pharmaceutical drug candidate team(s)
Arrowhead Pharmaceuticals, Inc. is a Nasdaq listed (ARWR) company that develops novel drugs to 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 (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. The Company's pipeline includes ARO-HBV for chronic hepatitis B virus, ARO-AAT for liver disease associated with alpha-1 antitrypsin deficiency (AATD), ARO-F12 for hereditary angioedema and thromboembolic disorders, ARO-HIF2 for renal cell carcinoma, and ARO-AMG1 for an undisclosed genetically validated cardiovascular target under a license and collaboration agreement with Amgen, Inc. ARO-LPA for cardiovascular disease was recently out-licensed to Amgen.
Arrowhead’s dynamic and innovative environment offers employees the opportunity to advance revolutionary treatments for serious and intractable diseases. Arrowhead's employees are smart, creative professionals who work collaboratively to meet the Company's business and scientific challenges. Arrowhead’s modern and well-equipped Research & Development ("R&D") facility is located in the Research Park in Madison, Wisconsin. The company is headquartered in Pasadena, CA.
225 South Lake Avenue, Suite 1050
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