Associate Scientist, CMC Analytical Development

Arrowhead Pharmaceuticals; Verona (WI); On-site; USD 75,000 - 90,000; Full time

Job summary

An established industry player is seeking an Associate Scientist to join their Analytical Development team. This exciting role involves supporting method development and validation for innovative drug substances, contributing to crucial GLP toxicology studies, and ensuring the quality of clinical trial materials. The ideal candidate will have a strong background in chemistry and analytical techniques, with a keen attention to detail and the ability to work collaboratively in a fast-paced environment. Join a forward-thinking organization that is dedicated to advancing therapies for patients in need and be part of a team that is making a real difference in the biopharmaceutical field.

Qualifications

• 4 years of experience in a chemistry lab and familiar with analytical instrumentation.
• Ability to analyze data and propose follow-up actions.

Responsibilities

• Support method development and validation for drug substances and products.
• Independently provide analytical results and meet project timelines.

Skills

Analytical techniques

Data analysis

Attention to detail

Team collaboration

Education

BS in Chemistry

MS in Chemistry

Tools

HPLC

GC

FTIR

UV/Vis

LC/MS

KF

Job description

Associate Scientist, CMC Analytical Development

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 part of the Analytical Development (AD) group within the CMC Manufacturing organization. The Associate Scientist III will support method development and validation activities for new drug substances and drug products. This role will also contribute to testing for GLP toxicology studies, cGMP clinical trial material release, and stability studies. The position reports to AD management.

Responsibilities

• Know and adhere to cGMP policies and procedures and relevant SOPs
• Independently provide accurate analytical results in support of new and on-going projects
• Independently meet project timelines and deliverables
• Perform testing of samples to support batch release and stability studies
• Perform portions of analytical techniques, such as HPLC, GC, FTIR, UV/Vis, LC/MS, KF, etc.
• Assist with the design and initiation for development of analytical methods and improvement of existing ones to support all stages of drug development process
• Handle, analyze and characterize chemicals, pharmaceuticals, and related organic molecules
• Evaluate and interpret scientific data and provide the significance of such
• Independently design and execute non-routine experiments
• Analyze data/results and interpret outcome of experiments and independently propose appropriate follow-up
• Compile data tables of results, certificate of analysis, and develop stability reports
• Write analytical test methods, protocols, and standard operating procedures
• Calibrate, maintain, and troubleshoot all analytical equipment
• Other duties as assigned

Requirements:

• BS or M.S. in Chemistry (or related area of study)
• 4 years of experience working in a chemistry laboratory setting.
• Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices.
• Ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up.
• Strong attention to detail.
• Works well with others and in a team environment.

Wisconsin pay range: $75,000—$90,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology