Qureos Mentor

Arrowhead Pharmaceuticals

<div>
 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&rsquo;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&rsquo;s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI &amp; 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 part of the Analytical Development (AD) group within the CMC Manufacturing organization. The Sr. AD Scientist will support method development and validation activities for new drug substances and drug products. Responsibilities include testing to support process development, impurity characterization, and activities related to GLP toxicology and cGMP clinical trial materials. This role reports to AD management.
 
 
 
 Responsibilities
 
 
 
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 Know and adhere to Arrowhead Core Values, cGMP policies and procedures and relevant SOPs
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 Provide accurate analytical results in support of new and on-going projects
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 Work independently and with project teams to meet and lead project timelines and deliverables
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 Provide leadership, technical guidance, and development to junior scientists
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 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
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 Prepare technical reports, presentations, SOPs, and policies and procedures
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 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
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 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
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 Develop specifications and test methods for raw materials, in-process and isolated intermediates, as well as drug products
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 Design and execute non-routine experiments
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 Analyze and interpret data/results and outcome of experiments and propose appropriate follow-up
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 Write project documentation (Analytical test methods, developmental reports, validation reports, and protocols) of higher complexity
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 Collaborate with other groups and activities necessary to ensure project deliverables are met
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 Perform peer review of notebooks, protocols, and validation documentation
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 Draft Out of Specification and Deviations documents
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 Perform testing of test samples in support of API and drug development
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 Calibrate, maintain, and troubleshoot all analytical equipment
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 May perform release testing of raw materials, stability study samples, method validation, and method transfer activities for toxicology and clinical trial activities when needed
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 Other duties as assigned
 
 
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 </ul>
 
 Requirements:
 
 
 
 <ul>
 <li>
 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.
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 Expertise in method development and validations in support of drug substance and drug product development, and manufacture
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 Skills and knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals and related organic molecules
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 Expertise with analytical instrumentation, and test methodology/validations
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 Knowledgeable with data acquisition systems, and cGMP policies and practices
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 Demonstrated experience with analytical instrumentation theory and practice as well as pharmaceutical drug substance and drug product development and processes
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 Has a solid understanding of CMC regulatory requirements for pharmaceutical products
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 Knowledgeable of cGMP, ICH, CDER requirements
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 Understanding of basic theories and principles of synthetic organic chemistry
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 Strong attention to detail
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 Can perform tasks assigned with minimal supervision
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 Works well with others and in a team environment
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 Can be flexible with changing priorities
 
 
 </li>
 </ul>
 Wisconsin pay range
 
 
 $110,000&mdash;$130,000 USD
 
 
 Arrowhead provides competitive salaries and an excellent benefit package.
 
 
 All applicants must have authorization to work in the US for a company.
 
 
 California Applicant Privacy Policy
</div>

Scientist / Sr. Scientist, CMC Analytical Development

<div>
 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&rsquo;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&rsquo;s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI &amp; 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. An Associate Scientist III, Quality Control will support the analytical testing of pharmaceutical raw materials, in-process samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. The Associate Scientist I will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Associate Scientist III is expected to perform several analytical techniques and can make sound scientific decisions under guidance from management. This position reports to QC Laboratory Management.
 
 
 2nd shift work hours are ~1pm &ndash; 11:30pm and includes a shift differential.
 
 
 
 Responsibilities
 
 
 
 responsibilities to this position:
 
 
 <ul>
 <li>
 Developing understanding and knowledge of cGMP requirements.
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 With guidance from laboratory leadership, works to meet project timelines and deliverables
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 Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and/or stability samples using established test methods and procedures
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 Executes training requirements, applies relevant SOPs and associated procedural guides
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 Ensures that training records are up to date and in compliance
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 Proficient with various analytical instrumentation theory and practice
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 Trains on, and becomes proficient with, a variety of analytical instrumentation (e.g., HPLC, GC, FT-IR, UV/Vis, KF, etc.)
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 Can set up various instrumentation for testing according to written test methods with little to no supervision
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 Plans and executes work related tasks with minimal supervision
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 Performs analyses in a timely manner
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 Works collaboratively with others
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 Shows initiative and interest in learning new techniques and tests
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 Identifies and troubleshoots analytical problems with instrumentation, general chemistry and computer applications
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 Quickly communicates analytical or sample issues to senior staff and/or management
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 Maintains a clear, concise and accurate laboratory notebook or worksheet records.
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 Reviews test data acquired by others, as applicable.
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 Drafts technical documents such as OOS/atypical investigations, deviations and CAPAs
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 Demonstrates good written and verbal communication skills
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 Proficient in analyzing data/results and interpret outcome of experiments and to propose appropriate follow-up with supervision.
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 Embraces cGMP requirements for all associated work
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 Works cooperatively in a team environment
 </li>
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 Establishing attention to detail
 </li>
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 Calibration, maintenance, and troubleshooting of analytical equipment with limited supervision.
 </li>
 <li>
 Remains flexible with changing priorities
 
 
 </li>
 </ul>
 
 Requirements:
 
 
 
 <ul>
 <li>
 BS. in Chemistry with 5 years of relevant laboratory experience
 </li>
 <li>
 Knowledgeable of cGMP laboratory requirements and operations
 </li>
 <li>
 Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and typical cGMP policies and practices.
 
 
 </li>
 </ul>
 Wisconsin pay range
 
 
 $80,000&mdash;$100,000 USD
 
 
 Arrowhead provides competitive salaries and an excellent benefit package.
 
 
 All applicants must have authorization to work in the US for a company.
 
 
 California Applicant Privacy Policy
</div>

Associate Scientist III, Quality Control (2nd Shift)

<div>
 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&rsquo;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&rsquo;s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI &amp; 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 Associate Manufacturing Scientist supports the production of drug substances and drug products. Their responsibility will focus on the preparation of solutions and reagents by following standard protocols. This technically focused position supports lab work, helps solve problems, and effectively communicates with colleagues.
 
 
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Follow batch records, SOPs, and work instructions to detail
 </li>
 <li>
 Document all operations in batch records and notebooks
 </li>
 <li>
 Comply with GMP protocols
 </li>
 <li>
 Assist other chemists within the CMC group during synthesis and chromatography of oligonucleotides including:
 </li>
 <ul>
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 Reagent solution preparation
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 <li>
 Column Packing
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 Mobile phase preparation
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 Fraction collection
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 </ul>
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 Operate TFF to desalt purified RNA solutions
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 Operate a lyophilizer and package solid drug substance
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 Execute processes as part of a team to ensure production timelines are kept and quality product is produced
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 <li>
 Maintain a clean work space
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 <li>
 Maintain safety by wearing required personal protective equipment
 
 
 </li>
 </ul>
 
 Requirements:
 
 
 
 <ul>
 <li>
 BS or MS in chemistry, biochemistry, engineering, or related scientific field
 </li>
 <li>
 Entry level to 5 years experience in a similar position
 </li>
 <li>
 Experience working in a GMP setting and controlled documentation
 </li>
 <li>
 Good verbal and written communication skills
 </li>
 <li>
 Ability to work in a team environment
 </li>
 <li>
 Ability to pay attention to detail
 
 
 </li>
 </ul>
 Wisconsin pay range
 
 
 $58,000&mdash;$68,000 USD
 
 
 Arrowhead provides competitive salaries and an excellent benefit package.
 
 
 All applicants must have authorization to work in the US for a company.
 
 
 California Applicant Privacy Policy
</div>

Associate Manufacturing Scientist I

Join Arrowhead Pharmaceuticals and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Arrowhead Pharmaceuticals

ABOUT_COMPANY

Scientist / Sr. Scientist, CMC Analytical Development

Associate Scientist III, Quality Control (2nd Shift)

Associate Manufacturing Scientist I