Jobs at Arrowhead Pharmaceuticals

Independently review laboratory and external data for accuracy, completeness, and GMP compliance. Investigate and document discrepancies, support release and stability reviews, audit/inspection readiness, and collaborate with labs and CDMOs. Mentor junior reviewers and recommend process improvements and digital/trend-analysis tools.

The Scientist I, Quality Control will conduct analytical testing for drug substances/products, support GLP Toxicology testing, and mentor co-workers, focusing on cGMP compliance and utilizing various analytical techniques.

The Revenue Accounting Manager will oversee partnership accounting, manage revenue recognition processes, and ensure compliance with ASC 606 and SOX controls. The role involves collaboration with FP&A, managing month-end closing processes, and preparing revenue-related disclosures.

The Senior Scientist I, DMPK will lead preclinical DMPK studies, manage data analysis, and ensure regulatory compliance for RNAi therapeutics.

The Corporate Counsel will provide legal guidance on drug pricing, market access, and reimbursement, while supporting internal stakeholders and managing outside counsel as required.

The Manager of Clinical Programming will support clinical studies by developing software for data management, collaborating with teams, and ensuring quality in programming outputs.

The Group Manager leads cross-functional CMC teams overseeing drug development projects, manages external relationships with partners, and ensures project alignment with timelines and quality standards.

The Director of IT Infrastructure leads the strategy and operations of the company's IT infrastructure, managing cloud platforms, team development, budget, compliance, and system reliability.

The Lab Assistant will maintain laboratory cleanliness, support production chemists with manufacturing activities, and follow safety and GMP protocols.

The GxP Laboratory Systems Administrator supports and manages laboratory systems within GxP environments, ensuring compliance and system functionality across various departments. Responsibilities include application administration, issue resolution, documentation for audits, and collaboration with internal teams and external partners.

The Associate Engineer II is responsible for supporting automation improvements, PLC and SCADA programming, troubleshooting, and project team cooperation to enhance manufacturing efficiency and compliance.

The Stability Coordinator manages Arrowhead's stability program, overseeing sample preparation, tracking, documentation, and communication with testing laboratories. They ensure adherence to quality standards and assist in data management.

Lead pharmacometrics and clinical pharmacology strategies for Arrowhead's global clinical development, ensuring scientific rigor and regulatory alignment in trial designs and submissions.

The Senior Manager Regulatory CMC oversees regulatory change control and post-approval activities, ensuring compliance with global standards while leveraging scientific principles and automation technologies to enhance efficiency.

The role involves antibody engineering, including designing mutant phage libraries, molecular cloning, purifying antibodies, and collaborating with teams to advance drug development.

The Director, Contracts & Pricing will develop and execute pricing strategies, optimize product access, monitor market dynamics, and collaborate cross-functionally to enhance brand value.

Support clinical operations by setting up and maintaining eTMF, managing user access, tracking vendor/site documents, preparing for inspections and audits, creating SOPs and training, and driving process improvements.

Provide regulatory review and strategic guidance for promotional and medical communications across channels, lead MLR meetings, manage FDA OPDP/2253 submissions, monitor enforcement trends, support product launches, develop SOPs, mentor junior staff, and collaborate cross-functionally to ensure compliant promotional materials.

Join the biometrics team to develop SDTM and ADaM dataset checks, perform QC from raw data to ADaM of key endpoints, deliver ad-hoc analyses, collaborate with data management and statisticians, participate in study team activities, and help develop departmental standards, processes, and training.

Lead and manage a team of safety scientists to oversee pharmacovigilance operations, signal detection, aggregate safety reporting (DSUR/IND Annual), vendor/CRO oversight, safety governance, regulatory compliance, QMS maintenance, and cross-functional safety support for clinical development and regulatory submissions.