Senior Scientist / Principal Scientist, Clinical Pharmacology
Arrowhead Pharmaceuticals job in Madison, WI
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 & 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 role provides clinical pharmacology and pharmacometrics leadership for assigned development programs and may be based in San Diego, CA or Madison, WI. The position is responsible for contributing to clinical trial design, authoring key protocol and regulatory sections, and performing hands-on PK/PD analyses to guide dose selection and program strategy. It oversees the preparation and authorization of PK analysis reports, CSR content, and clinical pharmacology components of global regulatory submissions
Responsibilities
Provide Clinical Pharmacology and pharmacometrics leadership for designated programs, contribute to design of clinical trial protocols and relevant sections in Investigational Brochure (IB), conduct hands-on analysis of clinical or translational PKPD data, support dosing strategies and clinical pharmacology planning. Authorize clinical PK analysis reports and relevant sections in the Clinical Study Report (CSR).
Provide high quality documentation of clinical pharmacology analysis compatible with global regulatory submission requirements. Authorize clinical pharmacology modules of CTD to support global filings of marketing application.
Provide timely communication of analysis results and interpretation with drug development teams.
Maintain a current understanding of clinical pharmacology literature and regulatory guidance for oligonucleotide/RNAi therapeutics
Requirements
PhD or PharmD in the field of pharmacokinetics, pharmacology or pharmaceutical science,
3 years of pharmaceutical industry experience in clinical-stage drug development.
Good understanding of FDA/EMA/ICH guidance related to clinical pharmacology
Established experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin with familiarity of authorizing PK study report.
Proficiency in NONMEM and skill of population PKPD modeling is essential.
Preferred:
PBPK/PD modeling
California pay range $120,000-$170,000 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
Auto-ApplyAssociate Scientist I, Small Scale Synthesis
Arrowhead Pharmaceuticals job in Madison, WI
Job Description
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 & 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
Arrowhead Pharmaceuticals is seeking an Associate Scientist I to join the Discovery Chemistry Department. The successful candidate will primarily focus on oligonucleotide synthesis, purification, analytical chemistry, and contributing to specific program goals. The Associate Scientist will be joining a team of highly motivated and experienced scientists and will contribute to the success of Arrowhead programs.
Responsibilities
Maintain a well-documented laboratory notebook
Track progress against project timelines, generate regular status updates, and communicate progress and issues to management
Manage time effectively to meet deadlines
Adhere to safe laboratory practices
Perform synthesis, purification, and analysis of oligonucleotides
Assist with maintenance of bioconjugate and oligonucleotide inventory
Requirements:
B.S. Chemistry or Biochemistry degree with excellent understanding of organic and analytical chemistry
0-2 years of experience working in a chemistry laboratory
Experience with a wide range of analytical techniques, especially HPLC
Ability to quickly learn new procedures and techniques
Preferred:
Experience working with large molecule synthetic targets (especially oligonucleotides) either in an academic or industry setting
Previous experience working in pharmaceutical setting
Wisconsin pay range $60,000-$70,000 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
Manager, Product Development & Operations
Arrowhead Pharmaceuticals job in Verona, WI
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 & 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 Manager, Product Development & Operations is accountable for the project and is responsible for the indirect management of CMC project teams from process development to delivery of finished goods to depots or 3PL(s). They will manage both internal and external CMC activities. They may manage external relationships and may act as the primary contact for outsourced contract manufacturing organizations (CMO) and contract research organizations (CRO) involved with the development, analysis, distribution, manufacturing, packaging, and labeling for Arrowhead drug development programs. The Manager, Product Development & Operations will facilitate team collaboration to identify risks, challenges, and opportunities for the project. They will work with Arrowhead leadership to prioritize work and assign tasks. They will manage vendor onboarding, contracts, project budgets, timelines, KPIs and deliverables. This is a non-laboratory position with responsibilities that require cross- functional collaboration with team members from technical, legal, finance, clinical, commercial, logistics, supply chain, quality, and regulatory functions.
Responsibilities
Oversee global operational activities: development, manufacturing, warehousing, distribution, supply chain, logistics
Act as primary point of contact for projects, facilitating communication between internal and external team members for CMC development, analytical, manufacturing, packaging, and labeling and distribution activities
Partner with the cross functional project team (chemistry, analytical, quality, regulatory, supply chain, clinical operations, commercial, marketing) to deliver quality product on time
Communicate project status and vendor activities to Arrowhead management and stakeholders
Monitor internal and external inventory of intermediates, API, investigational product, retains, samples, and clinical supplies
Manage budget, timeline, quality and deliverables for each project and vendor
Develop and implement global process standards, best practices
Develop and maintain and report KPIs for projects and external partners
Generate and maintain project tracking tools using Smartsheet, Excel, Power Bi and other databases
Work with technical, legal and finance groups to draft RFPs, track, manage and negotiate new contracts, supply agreements, confidentiality agreements, purchase orders, etc… for new and existing venders
Track and review vendor invoices; collaborate with finance department to process payments
Lead project meetings, vendor visits and conference calls
Oversee shipments and storage of GLP, GMP, and clinical materials in accordance with Arrowhead SOPs and GDP
Collaborate with clinical supply and supply chain to ensure materials are ready for current and up-coming developmental programs
Requirements
Bachelor's degree in a scientific discipline (e.g., Chemistry, Chemical Engineering, Biochemistry, or Biotechnology) and a minimum of 3 years of experience in a pharmaceutical company, contract manufacturing organization (CMO), or contract research organization (CRO); or
Master's degree in a scientific discipline (e.g., Chemistry, Chemical Engineering, Biochemistry, or Biotechnology) and at least 1 year of relevant experience in a pharmaceutical company, CMO, or CRO.
0-2 years in a project management or project coordination role
Knowledge of applicable GLP, GMP, GDP and regulatory guidance for pharmaceutical manufacturing and testing
Strong MS Office skills (Outlook, Excel, PowerPoint, and Word)
Excellent verbal and written communication skills
A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead
Ability to work prolonged periods at a desk and working on a computer.
Aptitude for independently resolving competing priorities in a fast-paced environment
Willingness and ability to travel on a limited basis (
Preferred:
Previous experience in pharmaceutical manufacturing, operations, clinical supply, or project management roles
Experience with Project Management Software such as Smart Sheet or MS Project
Experience with an ERP system such as Microsoft Dynamics (D365) or SAP
GLP or GMP Laboratory or Manufacturing experience
Wisconsin pay range $100,000-$115,000 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
Auto-ApplyGxP Laboratory Systems Administrator
Arrowhead Pharmaceuticals job in Verona, WI
Job Description
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 & 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 GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems including daily system administration of GxP systems across multiple departments including, Manufacturing, CMC, QC, BioAnalytical and DMPK and Clinical Pharmacology. The GxP Laboratory Systems Administrator will be responsible for defining standard business processes, configuring/testing/validating the software solutions, deploying the solutions across multiple Arrowhead Pharmaceuticals sites, and then supporting those software solutions. The position works closely with the business, consulting partners, and internal IS&I teams. The GxP Laboratory Systems Administrator will serve as an expert resource, bringing forth opportunities and other complementary solutions to help support the growth of Arrowhead Pharmaceuticals and influence decisions regarding business process changes.
Responsibilities
Business
Support and system administration for identified applications
Perform investigation and resolution efforts for technical and business process issues
Communicate technical issues and resolutions with users and department managers
Escalate issues to application vendors as necessary
Troubleshoot and collaborate with end users and departmental managers
Maintain a high level of functional subject matter knowledge for the assigned applications
Perform other duties as assigned
Regulatory
Perform periodic application review and management of user access
Represent the application documentation in client and regulatory audits
Contribute to audit finding responses
Contribute to computer system validation and computer software assurance projects, including application change control as required by GxP, Arrowhead Pharmaceuticals policies and SDLC
Draft CSV/CSA documentation for example, validation plans, design specifications, traceability matrices, functional user and user requirements specifications, test scripts, deviations, and summary reports
Information Systems and Informatics
Establish open communication between the business and Information Systems and Informatics
Triage escalation of technical issues to Information Systems and Informatics
Perform updates to the global systems inventory for applications
Coordinate release of new versions of applications into respective environments including Development, Testing and Production environments
Develop business scenarios to test applications
Verify installation and operation of applications
Document analysis and/or testing related to infrastructure changes. (e.g., operating system patches, significant network changes)
Requirements:
Bachelor's degree in computer science or life sciences, other related field, or equivalent experience
4+ years experience related to the administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment
Advanced knowledge of computer programs (e.g., MS Word, MS Excel, computerized data acquisition systems)
Ability to multi-task and participate in multiple projects and department initiatives concurrently
Ability to produce high quality results while working under the pressure of strict deadlines
Ability to function effectively independently, as necessary, and work with others to achieve team goals
Preferred:
Extensive experience validating and supporting Agilent laboratory systems (Openlab, Chemstation, Cary UV systems)
Excellent experience with pharmaceutical/CRO industry regulations, standards, and guidelines (GxP, CSV/CSA validation, 21 CFR Part 11, EU Annex 11, SDLC)
Experience with regulated environment asset management applications and environment monitor applications
Computer System Validation, 21 CFR Part 11, Annex 11, and GxP
Pharmaceutical or CRO experience
Project Management certification
Wisconsin pay range $90,000-$115,000 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
Data Reviewer, Analytical Development
Arrowhead Pharmaceuticals job in Verona, WI
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 & 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 Data Reviewer will ensure the quality of laboratory data and reports produced within Analytical Development (AD). This includes the review of analytical testing data and related notebooks as specified by Standard Operating Procedures (SOPs). This position will evaluate data to ensure compliance with analytical methods, specifications, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
Responsibilities:
Evaluates laboratory data from AD for compliance with analytical methods, specifications, and SOPs.
Reviews sample analysis results from AD for completeness and accurate representation of the data and report findings
Communicates with AD laboratory staff to proactively address the quality of laboratory documentation.
Prepares statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the laboratory staff and/or project leader for correction.
Conducts SOP preparation and review as well as consultation for GMP and Quality records.
Performs other duties as assigned.
Requirements:
Bachelor's degree in Chemistry (or related scientific field).
3+ years' relevant experience (pharmaceutical CMO/CRO).
Knowledge of cGMP guidelines for contract manufacturing and analytical laboratories and ICH/FDA guidance documents.
Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment.
Solid organizational skills with ability to adapt to changing priorities and deadlines.
Wisconsin pay range $70,000-$85,000 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
Auto-ApplyFacilities Technician (2nd Shift)
Arrowhead Pharmaceuticals job in Verona, WI
Job Description
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 & 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 Facilities Technician II position will support building operations during 2nd shift hours (starting at 1:00 PM). This position offers scheduling flexibility, with a choice of a 4-day workweek (four 10-hour shifts, Monday-Thursday) or a traditional 5-day schedule (five 8-hour shifts, Monday-Friday).
As the sole Facilities representative on second shift, the position will play a critical role in maintaining the safety, functionality, and appearance of our manufacturing and building infrastructure. This position is well suited for someone who thrives in a hands-on, independent work environment and takes pride in keeping complex facilities running smoothly and efficiently.
This position will serve as the primary point of contact for all facilities-related matters during second shift and must be comfortable making real-time decisions with minimal supervision. Responsibilities will include routine maintenance, urgent repairs, contractor coordination, and ensuring smooth handoffs with first-shift teams.
This role is eligible for a 10% shift differential.
Responsibilities
Serve as the primary Facilities point of contact during second shift, independently managing issues and ensuring timely resolution with minimal supervision.
Respond promptly to urgent maintenance situations (e.g., leaks, power outages, equipment malfunctions), prioritizing safety and operational continuity.
Perform routine building maintenance across multiple trades, including:
Carpentry
Painting and general repairs
Plumbing
Electrical
General Cleaning
HVAC support and diagnostics
Participate in a rotating non-business hour on call program to respond to emergency building maintenance issues and system failures including holidays and weekends.
Conduct regular inspections of building systems and infrastructure to identify and address maintenance needs proactively.
Accurately complete and document daily work orders and maintenance records using appropriate tools and systems.
Coordinate and oversee specialized contractors and OEM technicians, ensuring high-quality, compliant service on complex equipment.
Take initiative to identify facility issues or improvement opportunities and resolve or escalate as needed.
Strictly adhere to Environmental Health & Safety (EH&S) standards and internal procedures to maintain a safe and compliant working environment.
Assist with inventory management of critical spare parts and consumables to minimize downtime.
Ensure compliance with internal SOPs and external regulations, including cGMP, FDA, and OSHA guidelines.
Maintain all required training certifications and job qualifications in alignment with regulatory and site requirements.
Provide thorough shift handoffs, communicating effectively with first-shift personnel through logs, documentation, and in-person updates.
Demonstrate continuous growth in technical knowledge, problem-solving ability, and cross-functional communication.
Perform other duties as assigned.
Requirements:
High school diploma or equivalent required; post-secondary technical training a plus.
Minimum of 5 years of hands-on facilities or maintenance experience.
Proven knowledge in building systems maintenance, including:
Basic carpentry, painting, and drywall repair
Minor electrical work (e.g., lighting, outlets, ballasts)
Plumbing (e.g., leaks, drains, line installs)
HVAC troubleshooting and support
Demonstrated ability to troubleshoot, prioritize, and resolve issues independently, particularly during off-hours or without direct supervision.
Strong decision-making skills with a safety-first mindset and the ability to assess risk, root cause, and potential business impact in real time.
Experience collaborating with cross-functional teams (e.g., engineering, quality, contractors) to implement maintenance solutions and improvements.
Proficient in interpreting manuals, SOPs, and maintenance documentation.
Comfortable working in GMP-regulated or highly compliant environments; understanding of FDA, OSHA, EPA, EH&S, and Wisconsin state safety standards preferred.
Computer literacy, including working knowledge of Microsoft Office (Word, Excel, Outlook) and basic familiarity with digital work order systems (e.g., CMMS).
Strong communication skills, with the ability to write clear shift handoffs and verbally convey technical information to non-technical audiences.
Self-motivated, professional, and customer-oriented; takes initiative, follows through, and consistently delivers high-quality work.
Preferred:
Licensed tradesperson credentials such as a Journeyman Electrician or Refrigeration Technician license.
Prior maintenance experience in a pharmaceutical, biotech, or similarly regulated environment.
Familiarity with cGMP and cGDP principles, including proper documentation of maintenance work and maintaining clean, compliant workspaces.
Experience using Computerized Maintenance Management Systems (CMMS) to manage work orders, asset history, and inventory.
Resides within reasonable commuting distance of the facility and is available for occasional off-hours support.
Wisconsin pay range $63,000-$73,000 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
Winter Intern, Equipment Document Engineer
Arrowhead Pharmaceuticals, Inc. job in Madison, WI
Join our team as an Engineering Document Intern, where you'll play a key role in organizing, managing, and maintaining engineering documentation and records to ensure they're accurate, accessible, and compliant with internal standards. In this role, you'll support our Facilities Engineering & Automation teams by helping streamline documentation processes and ensuring timely distribution of technical materials to end users, contributing to the efficiency of ongoing projects and operations.
This is a full-time, six-month internship based fully onsite in Verona, WI, offering hands-on experience in a collaborative and fast-paced environment.
Payrate: $21.00/hour.
Responsibilities
* Assemble lifecycle document packages to support equipment qualification from information contained in project files.
* Locate equipment and instrumentation in the plant to identify make, model, and serial number of equipment and subcomponents.
* Locate manuals, cut sheets, and other similar information for equipment and subcomponents in project files or track down missing information from external sources.
* Organize information collected into equipment files to provide quick access to information by maintenance team members.
* Collaborate with engineering to ensure documentation packages reflect current system configuration.
Requirements:
* Currently enrolled student at an Accredited University or College and majoring in Chemical, Mechanical, or Electrical Engineering, or related area of study graduating December 2025.
* Familiar with reading engineering drawings (P&IDs, electrical diagrams, etc.)
* Able to locate physical items based on drawings and identify subcomponents (actuators, transmitters, switches, etc.)
* Excellent organizational skills with high attention to detail
* Excellent verbal and written communication skills
* Strong problem-solving skills
* Eagerness to learn new techniques
* Ability to work in a lab setting for prolonged periods of time
* Ability to wear personal protective equipment as required
* Must be able to lift 15 pounds at a time
* Ability to work independently
Preferred
* Exposure to a manufacturing environment.
* Experience extracting information from equipment cutsheets and manuals.
* Familiar working with equipment quality certificates and test result documentation.
* Prior experience with document organization and management systems.
* Prior experience with assembling bills of materials, manuals for manufacturing systems, or construction turnover packages.
Auto-ApplyManager, Artwork & Labeling
Arrowhead Pharmaceuticals job in Verona, WI
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 & 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 Manager, Artwork & Labeling is a detail-oriented and results-driven individual with a strong understanding of graphic design, pharmaceutical packaging regulations, GMP standards and workload management. This person is responsible for the creation, management, and implementation of commercial product labelling artwork. This position liaises and promotes exchanges in Global Operations, as well as with Regulatory Affairs, Quality, Supply Chain Planning, Marketing and Global Affiliates to ensure labelling change requests comply with company standards and are implemented in accordance with regulations and production schedules.
Responsibilities
Align artwork process strategies with broader Supply Chain, Regulatory, Quality, and Commercial objectives.
Establish and maintain global governance frameworks, including SOPs, KPIs, change controls, and audit readiness protocols.
Define and implement artwork workflows, documentation controls, and system interactions with appropriate stakeholders to ensure process consistency, quality, and traceability.
Collaborate with Packaging and Device Engineering on product label/artwork development.
Manage mock-up and artwork requests for labeling components, from development through review and approval to production implementation.
Collaborate with Regulatory Affairs to create mock-ups supporting regulatory submissions and licensing activities, ensuring project timelines and milestones are met.
Prepare error-free mock-ups and artwork using graphic design software and tools, interfacing with other functions within Arrowhead as well as printing/packaging vendors.
Arrowhead point of contact for artwork vendors.
Coordinate with external vendors, Procurement, and Supply Chain to ensure timely production. Optimize production processes for maximum efficiency, quality, and on-time delivery.
Research and assess global labeling regulations and guidance documents, assisting in the development of procedures, guidelines, and maintenance systems for labeling development, approval, and control, while maintaining documentation and logs both in hardcopy and electronically.
Oversee global artwork change control processes and validation protocols.
Other duties as assigned
Requirements
Bachelor's Degree in Graphic Design or a related field.
5 years of professional design experience.
Proficiency in problem-solving, communication, technical writing, and organization.
Knowledge of software programs such as Adobe InDesign, Illustrator, Acrobat, Word, Excel, PowerPoint, and Outlook.
Strong understanding of regulatory compliance requirements (e.g., GMP, CCDS, HA submissions) and global artwork-related standards and best practices.
Experience in pharmaceuticals, packaging, and workflow.
Preferred:
Regulatory certifications (e.g., RAC) or equivalent professional credentials
Wisconsin pay range $90,000-$115,000 USDCalifornia pay range $105,000-$125,000 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
Auto-ApplyAssociate Director, Device Engineering
Arrowhead Pharmaceuticals job in Verona, WI
Job Description
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 & 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 Director, Device Engineering is a detail-oriented and results-driven individual with a strong understanding of product design, pharmaceutical device regulations, GMP standards and workload management. This individual is responsible for driving commercial readiness and managing the life cycle of drug device combination products. This role will work closely with Global Operations, Development, Quality, Procurement, Regulatory, Packaging Engineering, consultants and outside vendors.
Responsibilities
Develop and oversee design control system and business strategies to support commercial device/combination drug development.
Create and execute project plans and schedules.
Develop, execute, and manage documents for product design, specifications, development plans, characterization plans, verification/validation plans, risk management, human factors and other related product development documents.
Author or Review/Approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
Participate in design reviews, provide critical design for manufacturing input to ensure product designs are robust for manufacturing.
Support site and vendor risk assessments, develop and maintain pFMEAs, and develop control plans to mitigate risks. Ensure that all product functional requirements are translated into manufacturing requirements and process controls.
Provide technical support for CMO/vendor sourcing activities.
Sponsor and/or lead projects, initiatives, and process improvements falling under device engineering business systems scope to build for the future.
Requirements
Bachelor's Degree in Engineering or other field related to the essential duties of this role and 10+ years of increasing responsibility in medical device industry, focused on engineering processes and procedures. (or a Master's Degree with 8+ years of experience, or a Doctorate Degree with 5+ years of experience.)
Strong MS Office skills (Outlook, Excel, PowerPoint, and Word)
Excellent verbal and written communication skills
A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead
Ability to work prolonged periods at a desk and working on a computer.
Aptitude for independently resolving competing priorities in a fast-paced environment
Preferred:
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Experience with product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.
Wisconsin pay range $170,000-$190,000 USDCalifornia pay range $180,000-$200,000 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
Associate Engineer, cGMP Computer Systems Validation
Arrowhead Pharmaceuticals job in Verona, WI
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 & 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 will work within the cGMP, GLP, and GCP-regulated Quality organization to provide validation and lifecycle support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced, and/or modified. The in cumbent will be responsible for guiding, generating, reviewing, and/or approving system assessments, test scripts, change controls, process improvements, and data integrity and governance at the applicable points of the system lifecycle. The position will serve as the subject matter expert to provide compliance leadership and oversight for CSV projects, collaborating with business partners to maintain and improve computer system validation processes.
Responsibilities
Provides Quality guidance for CSV efforts related to requirements engineering, system risk assessments, and data integrity assessments.
Reviews and approves validation documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Functional Requirements Specifications, Testing Protocols, Requirements Trace Matrices, and Summary Reports
Serve as an SME for CSV and maintain knowledge and information in the Computer System Validation area of expertise
Review CSV documentation to ensure data integrity requirements are maintained
Review and approve discrepancies / deviations encountered during qualification / validation activities
Review, assess, and approve computerized system change controls
Coordinate validation activities with key stakeholders
Provide direction to validation contractors (if required)
Communicate CSV approach in support of audits
Prepare documentation and provide support for regulatory inspections and inspection readiness activities.
Review and approve periodic reviews of system validation. Ensure appropriate remediation plans are determined for gaps identified during periodic reviews.
Requirements:
Bachelor's degree in an applicable science field.
Additional Quality related certification desired, CQA, CQMP
Minimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization with expanding responsibilities related to computerized system, equipment, and/or instrument qualification.
Working knowledge of overall GMP and/or GLP FDA, EU, and ICH regulations.
Preferred:
Prior experience with use of an electronic document management system in a regulated environment.
Wisconsin pay range $80,000-$95,000 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
Auto-ApplySenior Manager, Metrology and Process Equipment
Arrowhead Pharmaceuticals job in Verona, WI
Job Description
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 & 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 Senior Manager, Metrology and Process Equipment is responsible for coordinating and executing manufacturing equipment and analytical instrument lifecyle management strategies. They will oversee the maintenance, repair, calibration, and safe operation of all equipment used in GMP and GLP activities. This position will be responsible for ensuring that equipment is maintained and meets applicable regulatory requirements to support ongoing operations in a fast-paced drug substance manufacturing facility and regulated development laboratories. This position leads the Metrology team by establishing clear direction and setting priority for operational and strategic project execution. This position will be the central point of coordination and communication for cross-functional departments supported by the Metrology team and will be responsible for establishing effective team communication practices with internal customers.
Responsibilities
Develop and oversee execution of strategic plans to grow the equipment maintenance and calibration program at Arrowhead to support new systems and internalize contracted work.
Work cross functionally to provide oversight of the transfer of maintenance and calibration responsibility to the maintenance unit from technical experts in Engineering, including establishing maintenance procedures, training plans, spare parts inventories, and service contracts.
Partner with quality, internal customers, and supporting departments to improve and optimize maintenance and calibration workflows by developing strategic plans for continuous improvements and oversee plan execution.
Provide guidance in the investigation and resolution of calibration and maintenance issues by technical team members within and outside the reporting structure.
Develop and report on performance metrics for the Metrology team focusing on service effectiveness and equipment performance. Lead projects to identify and implement improvements.
Provide managerial leadership for the Metrology team including individual development plans, goal setting, performance evaluations, recruitment and retention, and ongoing guidance and feedback for team leaders and technical experts.
Organize assignments and resources across the Metrology team to ensure preventative and corrective maintenance is completed on schedule to support business priorities and according to quality and procedural requirements.
Effectively communicate with cross functional leaders and individual contributors to achieve team and business objectives
Establish team expectations and policy for communication practices with internal customers and models best practices.
Responsible for ensuring that the Metrology team has the tools, expertise, and training needed to safely and successfully complete assigned work.
Partner with Environmental Health & Safety to identify support needs and lead implementation of safe work policies and practices within the Metrology team.
Ensure safety practices and policies are adhered to across the Metrology team and by service vendors.
Represent the maintenance function for change review, approval, and implementation. Lead change adoption by impacted Metrology team members.
Represent business ownership of Arrowhead's regulatory asset management system. Develop a strategic plan for ongoing system issues and enhancements and partner with system administrators in IS&I for implementation.
Responsible for the quality and consistency of service records, asset management system data, and equipment files.
Develop the annual maintenance budget for the Metrology team and tracks department spend against approved budget throughout the year.
Provide oversight and organization for maintenance service contract renewals with support from the Purchasing.
Requirements:
BS degree in engineering / related technical field or equivalent work experience.
At least 10+ years of maintenance or metrology experience preferably within pharmaceutical or similarly regulated environment; at least of which 5 years were in a maintenance leadership role within a pharmaceutical or similarly regulated environment.
Advanced knowledge of mechanical and electrical systems.
Knowledge of maintenance requirements for manufacturing process equipment such as purified water, clean in place, buffer formulation, and reagent distribution systems.
Prior experience with safe work practices such as lockout tagout, hot work permits, and line break procedures.
Experience selecting and managing external service vendors.
Proficiency with Computerized Maintenance Management Systems, including best practices for asset identification and hierarchies.
Preferred:
Knowledgeable on best practices for calibration common instruments used for pressure, temperature, flow, and weight measurement in a regulated environment.
Experience with safe work practices for electrically classified areas
Knowledge of analytical instrument maintenance and calibration practices, including HPLCs.
Prior experience with Blue Mountain Regulatory Asset Manager
Prior experience with change controls for equipment and instrument systems in regulated and/or hazardous environments.
Prior experience with maintenance on automated process equipment.
Wisconsin pay range $150,000-$165,000 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
Data Reviewer, Quality Control
Arrowhead Pharmaceuticals job in Verona, WI
Job Description
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 & 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 Data Reviewer is responsible for ensuring the completion, quality, and compliance of laboratory data and reports produced within the Quality Control (QC) team. This includes the technical review of analytical testing data and related notebooks, forms, logbooks, and more as specified by Standard Operating Procedures (SOPs). This position will evaluate data to ensure compliance with analytical methods, specifications, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) standards. This position will manage deadlines for review completion and aid in the organization and maintenance of data. The ideal candidate will have experience with analytical testing, either in performance or technical review.
Responsibilities:
Evaluate QC laboratory data for compliance with analytical methods, protocols, specifications, and SOPs.
Review sample analysis results for completeness and accurate representation of the data and report findings.
Communicate with QC laboratory staff to proactively address the quality of laboratory documentation.
Prepare statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the project leader for correction.
Conduct SOP review and writing as well as conducts consultations for quality records.
Work cross-functionally to harmonize data review practices and produce a consistent product.
Perform other duties as assigned.
Requirements:
Bachelor's degree in Chemistry (or related scientific field).
2+ years' relevant experience (pharmaceutical CMO/CRO).
Knowledge of cGMP and cGLP guidelines for contract manufacturing and analytical laboratories and ICH/FDA guidance documents.
Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment.
Solid organizational skills with ability to adapt to changing priorities and deadlines.
Wisconsin pay range $70,000-$85,000 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
Facilities Technician (2nd Shift)
Arrowhead Pharmaceuticals job in Verona, WI
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 & 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 Facilities Technician II position will support building operations during 2nd shift hours (starting at 1:00 PM). This position offers scheduling flexibility, with a choice of a 4-day workweek (four 10-hour shifts, Monday-Thursday) or a traditional 5-day schedule (five 8-hour shifts, Monday-Friday).
As the sole Facilities representative on second shift, the position will play a critical role in maintaining the safety, functionality, and appearance of our manufacturing and building infrastructure. This position is well suited for someone who thrives in a hands-on, independent work environment and takes pride in keeping complex facilities running smoothly and efficiently.
This position will serve as the primary point of contact for all facilities-related matters during second shift and must be comfortable making real-time decisions with minimal supervision. Responsibilities will include routine maintenance, urgent repairs, contractor coordination, and ensuring smooth handoffs with first-shift teams.
This role is eligible for a 10% shift differential.
Responsibilities
Serve as the primary Facilities point of contact during second shift, independently managing issues and ensuring timely resolution with minimal supervision.
Respond promptly to urgent maintenance situations (e.g., leaks, power outages, equipment malfunctions), prioritizing safety and operational continuity.
Perform routine building maintenance across multiple trades, including:
Carpentry
Painting and general repairs
Plumbing
Electrical
General Cleaning
HVAC support and diagnostics
Participate in a rotating non-business hour on call program to respond to emergency building maintenance issues and system failures including holidays and weekends.
Conduct regular inspections of building systems and infrastructure to identify and address maintenance needs proactively.
Accurately complete and document daily work orders and maintenance records using appropriate tools and systems.
Coordinate and oversee specialized contractors and OEM technicians, ensuring high-quality, compliant service on complex equipment.
Take initiative to identify facility issues or improvement opportunities and resolve or escalate as needed.
Strictly adhere to Environmental Health & Safety (EH&S) standards and internal procedures to maintain a safe and compliant working environment.
Assist with inventory management of critical spare parts and consumables to minimize downtime.
Ensure compliance with internal SOPs and external regulations, including cGMP, FDA, and OSHA guidelines.
Maintain all required training certifications and job qualifications in alignment with regulatory and site requirements.
Provide thorough shift handoffs, communicating effectively with first-shift personnel through logs, documentation, and in-person updates.
Demonstrate continuous growth in technical knowledge, problem-solving ability, and cross-functional communication.
Perform other duties as assigned.
Requirements:
High school diploma or equivalent required; post-secondary technical training a plus.
Minimum of 5 years of hands-on facilities or maintenance experience.
Proven knowledge in building systems maintenance, including:
Basic carpentry, painting, and drywall repair
Minor electrical work (e.g., lighting, outlets, ballasts)
Plumbing (e.g., leaks, drains, line installs)
HVAC troubleshooting and support
Demonstrated ability to troubleshoot, prioritize, and resolve issues independently, particularly during off-hours or without direct supervision.
Strong decision-making skills with a safety-first mindset and the ability to assess risk, root cause, and potential business impact in real time.
Experience collaborating with cross-functional teams (e.g., engineering, quality, contractors) to implement maintenance solutions and improvements.
Proficient in interpreting manuals, SOPs, and maintenance documentation.
Comfortable working in GMP-regulated or highly compliant environments; understanding of FDA, OSHA, EPA, EH&S, and Wisconsin state safety standards preferred.
Computer literacy, including working knowledge of Microsoft Office (Word, Excel, Outlook) and basic familiarity with digital work order systems (e.g., CMMS).
Strong communication skills, with the ability to write clear shift handoffs and verbally convey technical information to non-technical audiences.
Self-motivated, professional, and customer-oriented; takes initiative, follows through, and consistently delivers high-quality work.
Preferred:
Licensed tradesperson credentials such as a Journeyman Electrician or Refrigeration Technician license.
Prior maintenance experience in a pharmaceutical, biotech, or similarly regulated environment.
Familiarity with cGMP and cGDP principles, including proper documentation of maintenance work and maintaining clean, compliant workspaces.
Experience using Computerized Maintenance Management Systems (CMMS) to manage work orders, asset history, and inventory.
Resides within reasonable commuting distance of the facility and is available for occasional off-hours support.
Wisconsin pay range $63,000-$73,000 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
Auto-ApplyAssociate Scientist I, Small Scale Synthesis
Arrowhead Pharmaceuticals job in Madison, WI
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 & 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
Arrowhead Pharmaceuticals is seeking an Associate Scientist I to join the Discovery Chemistry Department. The successful candidate will primarily focus on oligonucleotide synthesis, purification, analytical chemistry, and contributing to specific program goals. The Associate Scientist will be joining a team of highly motivated and experienced scientists and will contribute to the success of Arrowhead programs.
Responsibilities
Maintain a well-documented laboratory notebook
Track progress against project timelines, generate regular status updates, and communicate progress and issues to management
Manage time effectively to meet deadlines
Adhere to safe laboratory practices
Perform synthesis, purification, and analysis of oligonucleotides
Assist with maintenance of bioconjugate and oligonucleotide inventory
Requirements:
B.S. Chemistry or Biochemistry degree with excellent understanding of organic and analytical chemistry
0-2 years of experience working in a chemistry laboratory
Experience with a wide range of analytical techniques, especially HPLC
Ability to quickly learn new procedures and techniques
Preferred:
Experience working with large molecule synthetic targets (especially oligonucleotides) either in an academic or industry setting
Previous experience working in pharmaceutical setting
Wisconsin pay range $60,000-$70,000 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
Auto-ApplyGxP Laboratory Systems Administrator
Arrowhead Pharmaceuticals job in Verona, WI
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 & 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 GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems including daily system administration of GxP systems across multiple departments including, Manufacturing, CMC, QC, BioAnalytical and DMPK and Clinical Pharmacology. The GxP Laboratory Systems Administrator will be responsible for defining standard business processes, configuring/testing/validating the software solutions, deploying the solutions across multiple Arrowhead Pharmaceuticals sites, and then supporting those software solutions. The position works closely with the business, consulting partners, and internal IS&I teams. The GxP Laboratory Systems Administrator will serve as an expert resource, bringing forth opportunities and other complementary solutions to help support the growth of Arrowhead Pharmaceuticals and influence decisions regarding business process changes.
Responsibilities
Business
Support and system administration for identified applications
Perform investigation and resolution efforts for technical and business process issues
Communicate technical issues and resolutions with users and department managers
Escalate issues to application vendors as necessary
Troubleshoot and collaborate with end users and departmental managers
Maintain a high level of functional subject matter knowledge for the assigned applications
Perform other duties as assigned
Regulatory
Perform periodic application review and management of user access
Represent the application documentation in client and regulatory audits
Contribute to audit finding responses
Contribute to computer system validation and computer software assurance projects, including application change control as required by GxP, Arrowhead Pharmaceuticals policies and SDLC
Draft CSV/CSA documentation for example, validation plans, design specifications, traceability matrices, functional user and user requirements specifications, test scripts, deviations, and summary reports
Information Systems and Informatics
Establish open communication between the business and Information Systems and Informatics
Triage escalation of technical issues to Information Systems and Informatics
Perform updates to the global systems inventory for applications
Coordinate release of new versions of applications into respective environments including Development, Testing and Production environments
Develop business scenarios to test applications
Verify installation and operation of applications
Document analysis and/or testing related to infrastructure changes. (e.g., operating system patches, significant network changes)
Requirements:
Bachelor's degree in computer science or life sciences, other related field, or equivalent experience
4+ years experience related to the administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment
Advanced knowledge of computer programs (e.g., MS Word, MS Excel, computerized data acquisition systems)
Ability to multi-task and participate in multiple projects and department initiatives concurrently
Ability to produce high quality results while working under the pressure of strict deadlines
Ability to function effectively independently, as necessary, and work with others to achieve team goals
Preferred:
Extensive experience validating and supporting Agilent laboratory systems (Openlab, Chemstation, Cary UV systems)
Excellent experience with pharmaceutical/CRO industry regulations, standards, and guidelines (GxP, CSV/CSA validation, 21 CFR Part 11, EU Annex 11, SDLC)
Experience with regulated environment asset management applications and environment monitor applications
Computer System Validation, 21 CFR Part 11, Annex 11, and GxP
Pharmaceutical or CRO experience
Project Management certification
Wisconsin pay range $90,000-$115,000 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
Auto-ApplyManager, Artwork & Labeling
Arrowhead Pharmaceuticals job in Verona, WI
Job Description
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 & 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 Manager, Artwork & Labeling is a detail-oriented and results-driven individual with a strong understanding of graphic design, pharmaceutical packaging regulations, GMP standards and workload management. This person is responsible for the creation, management, and implementation of commercial product labelling artwork. This position liaises and promotes exchanges in Global Operations, as well as with Regulatory Affairs, Quality, Supply Chain Planning, Marketing and Global Affiliates to ensure labelling change requests comply with company standards and are implemented in accordance with regulations and production schedules.
Responsibilities
Align artwork process strategies with broader Supply Chain, Regulatory, Quality, and Commercial objectives.
Establish and maintain global governance frameworks, including SOPs, KPIs, change controls, and audit readiness protocols.
Define and implement artwork workflows, documentation controls, and system interactions with appropriate stakeholders to ensure process consistency, quality, and traceability.
Collaborate with Packaging and Device Engineering on product label/artwork development.
Manage mock-up and artwork requests for labeling components, from development through review and approval to production implementation.
Collaborate with Regulatory Affairs to create mock-ups supporting regulatory submissions and licensing activities, ensuring project timelines and milestones are met.
Prepare error-free mock-ups and artwork using graphic design software and tools, interfacing with other functions within Arrowhead as well as printing/packaging vendors.
Arrowhead point of contact for artwork vendors.
Coordinate with external vendors, Procurement, and Supply Chain to ensure timely production. Optimize production processes for maximum efficiency, quality, and on-time delivery.
Research and assess global labeling regulations and guidance documents, assisting in the development of procedures, guidelines, and maintenance systems for labeling development, approval, and control, while maintaining documentation and logs both in hardcopy and electronically.
Oversee global artwork change control processes and validation protocols.
Other duties as assigned
Requirements
Bachelor's Degree in Graphic Design or a related field.
5 years of professional design experience.
Proficiency in problem-solving, communication, technical writing, and organization.
Knowledge of software programs such as Adobe InDesign, Illustrator, Acrobat, Word, Excel, PowerPoint, and Outlook.
Strong understanding of regulatory compliance requirements (e.g., GMP, CCDS, HA submissions) and global artwork-related standards and best practices.
Experience in pharmaceuticals, packaging, and workflow.
Preferred:
Regulatory certifications (e.g., RAC) or equivalent professional credentials
Wisconsin pay range $90,000-$115,000 USDCalifornia pay range $105,000-$125,000 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
Associate Director, Packaging Engineering
Arrowhead Pharmaceuticals job in Verona, WI
Job Description
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 & 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 Director, Packaging Engineering is responsible for the technical aspects of commercial packaging for drug substance, drug product, primary container/closure, and final product presentations including secondary/tertiary packaging/configuration for shipment. This position will lead the design and development of packaging for commercialization of new products through the design transfer process, as well as manage changes to existing products. This role will work closely with Global Operations, Development, Quality, Procurement, Regulatory, Device Engineering, and outside vendors.
Responsibilities
Create and implement long-term packaging development strategy.
Create and execute project plans and schedules.
Lead and execute packaging strategies on projects, working with internal and external stakeholders to develop packaging designs, materials, and processes for new products.
Create and maintain packaging design and packaging validation programs compliant with packaging laws, industry-recognized standards, and test methods.
Develop, execute, and manage documents for packaging specifications, development plans, testing protocols, qualification/validation plans, risk management, and other related packaging development documents.
Initiate/review change controls, deviations, CAPAs, and risk assessments related to packaging components/configuration within QMS in collaboration with Quality. Support root cause analysis activities.
Drive continuous improvement in the packaging processes from project initiation through launch as well as life cycle management in alignment with regulatory and commercial manufacturing requirements.
Provide technical support for commercial packaging vendor sourcing activities.
Sponsor and/or lead projects, initiatives, and process improvements falling under packaging engineering business systems scope to build for the future.
All other duties as assigned.
Requirements
Bachelor's Degree in Engineering or other field related to the essential duties of this role and 10+ years of increasing responsibility in pharmaceutical industry, focused on packaging processes and procedures. (or a Master's Degree with 8+ years of experience, or a Doctorate Degree with 5+ years of experience.)
Strong problem solving, risk assessment, and risk management skills and capable of working on multiple projects in a deadline driven environment.
Exhibits excellent interpersonal communication, project management, collaboration, and analytical skills.
Strong MS Excel, PowerPoint, and Word skills.
Experience using Smartsheet or other work management software.
Exhibits creativity in adapting to changing situations, development of contingency plans and comfortable with making decisions.
Preferred:
Expertise in testing, validation, packaging laws, industry-recognized standards and test methods (e.g., ASTM, ISTA, ISO, USP), regulations (e.g., ISO 11607, 21 CFR 820), and risk management to identify and recommend design improvements that address deficiencies.
Experience developing and commercializing new products on cross-functional teams.
Experience with cold chain products.
Wisconsin pay range $170,000-$190,000 USDCalifornia pay range $180,000-$200,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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Associate Engineer, cGMP Computer Systems Validation
Arrowhead Pharmaceuticals job in Verona, WI
Job Description
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 & 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 will work within the cGMP, GLP, and GCP-regulated Quality organization to provide validation and lifecycle support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced, and/or modified. The in cumbent will be responsible for guiding, generating, reviewing, and/or approving system assessments, test scripts, change controls, process improvements, and data integrity and governance at the applicable points of the system lifecycle. The position will serve as the subject matter expert to provide compliance leadership and oversight for CSV projects, collaborating with business partners to maintain and improve computer system validation processes.
Responsibilities
Provides Quality guidance for CSV efforts related to requirements engineering, system risk assessments, and data integrity assessments.
Reviews and approves validation documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Functional Requirements Specifications, Testing Protocols, Requirements Trace Matrices, and Summary Reports
Serve as an SME for CSV and maintain knowledge and information in the Computer System Validation area of expertise
Review CSV documentation to ensure data integrity requirements are maintained
Review and approve discrepancies / deviations encountered during qualification / validation activities
Review, assess, and approve computerized system change controls
Coordinate validation activities with key stakeholders
Provide direction to validation contractors (if required)
Communicate CSV approach in support of audits
Prepare documentation and provide support for regulatory inspections and inspection readiness activities.
Review and approve periodic reviews of system validation. Ensure appropriate remediation plans are determined for gaps identified during periodic reviews.
Requirements:
Bachelor's degree in an applicable science field.
Additional Quality related certification desired, CQA, CQMP
Minimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization with expanding responsibilities related to computerized system, equipment, and/or instrument qualification.
Working knowledge of overall GMP and/or GLP FDA, EU, and ICH regulations.
Preferred:
Prior experience with use of an electronic document management system in a regulated environment.
Wisconsin pay range $80,000-$95,000 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
Senior Manager, Metrology and Process Equipment
Arrowhead Pharmaceuticals job in Verona, WI
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 & 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 Senior Manager, Metrology and Process Equipment is responsible for coordinating and executing manufacturing equipment and analytical instrument lifecyle management strategies. They will oversee the maintenance, repair, calibration, and safe operation of all equipment used in GMP and GLP activities. This position will be responsible for ensuring that equipment is maintained and meets applicable regulatory requirements to support ongoing operations in a fast-paced drug substance manufacturing facility and regulated development laboratories. This position leads the Metrology team by establishing clear direction and setting priority for operational and strategic project execution. This position will be the central point of coordination and communication for cross-functional departments supported by the Metrology team and will be responsible for establishing effective team communication practices with internal customers.
Responsibilities
Develop and oversee execution of strategic plans to grow the equipment maintenance and calibration program at Arrowhead to support new systems and internalize contracted work.
Work cross functionally to provide oversight of the transfer of maintenance and calibration responsibility to the maintenance unit from technical experts in Engineering, including establishing maintenance procedures, training plans, spare parts inventories, and service contracts.
Partner with quality, internal customers, and supporting departments to improve and optimize maintenance and calibration workflows by developing strategic plans for continuous improvements and oversee plan execution.
Provide guidance in the investigation and resolution of calibration and maintenance issues by technical team members within and outside the reporting structure.
Develop and report on performance metrics for the Metrology team focusing on service effectiveness and equipment performance. Lead projects to identify and implement improvements.
Provide managerial leadership for the Metrology team including individual development plans, goal setting, performance evaluations, recruitment and retention, and ongoing guidance and feedback for team leaders and technical experts.
Organize assignments and resources across the Metrology team to ensure preventative and corrective maintenance is completed on schedule to support business priorities and according to quality and procedural requirements.
Effectively communicate with cross functional leaders and individual contributors to achieve team and business objectives
Establish team expectations and policy for communication practices with internal customers and models best practices.
Responsible for ensuring that the Metrology team has the tools, expertise, and training needed to safely and successfully complete assigned work.
Partner with Environmental Health & Safety to identify support needs and lead implementation of safe work policies and practices within the Metrology team.
Ensure safety practices and policies are adhered to across the Metrology team and by service vendors.
Represent the maintenance function for change review, approval, and implementation. Lead change adoption by impacted Metrology team members.
Represent business ownership of Arrowhead's regulatory asset management system. Develop a strategic plan for ongoing system issues and enhancements and partner with system administrators in IS&I for implementation.
Responsible for the quality and consistency of service records, asset management system data, and equipment files.
Develop the annual maintenance budget for the Metrology team and tracks department spend against approved budget throughout the year.
Provide oversight and organization for maintenance service contract renewals with support from the Purchasing.
Requirements:
BS degree in engineering / related technical field or equivalent work experience.
At least 10+ years of maintenance or metrology experience preferably within pharmaceutical or similarly regulated environment; at least of which 5 years were in a maintenance leadership role within a pharmaceutical or similarly regulated environment.
Advanced knowledge of mechanical and electrical systems.
Knowledge of maintenance requirements for manufacturing process equipment such as purified water, clean in place, buffer formulation, and reagent distribution systems.
Prior experience with safe work practices such as lockout tagout, hot work permits, and line break procedures.
Experience selecting and managing external service vendors.
Proficiency with Computerized Maintenance Management Systems, including best practices for asset identification and hierarchies.
Preferred:
Knowledgeable on best practices for calibration common instruments used for pressure, temperature, flow, and weight measurement in a regulated environment.
Experience with safe work practices for electrically classified areas
Knowledge of analytical instrument maintenance and calibration practices, including HPLCs.
Prior experience with Blue Mountain Regulatory Asset Manager
Prior experience with change controls for equipment and instrument systems in regulated and/or hazardous environments.
Prior experience with maintenance on automated process equipment.
Wisconsin pay range $150,000-$165,000 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
Auto-ApplyData Reviewer, Quality Control
Arrowhead Pharmaceuticals job in Verona, WI
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 & 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 Data Reviewer is responsible for ensuring the completion, quality, and compliance of laboratory data and reports produced within the Quality Control (QC) team. This includes the technical review of analytical testing data and related notebooks, forms, logbooks, and more as specified by Standard Operating Procedures (SOPs). This position will evaluate data to ensure compliance with analytical methods, specifications, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) standards. This position will manage deadlines for review completion and aid in the organization and maintenance of data. The ideal candidate will have experience with analytical testing, either in performance or technical review.
Responsibilities:
Evaluate QC laboratory data for compliance with analytical methods, protocols, specifications, and SOPs.
Review sample analysis results for completeness and accurate representation of the data and report findings.
Communicate with QC laboratory staff to proactively address the quality of laboratory documentation.
Prepare statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the project leader for correction.
Conduct SOP review and writing as well as conducts consultations for quality records.
Work cross-functionally to harmonize data review practices and produce a consistent product.
Perform other duties as assigned.
Requirements:
Bachelor's degree in Chemistry (or related scientific field).
2+ years' relevant experience (pharmaceutical CMO/CRO).
Knowledge of cGMP and cGLP guidelines for contract manufacturing and analytical laboratories and ICH/FDA guidance documents.
Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment.
Solid organizational skills with ability to adapt to changing priorities and deadlines.
Wisconsin pay range $70,000-$85,000 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
Auto-Apply