Jobs at Arrowhead Pharmaceuticals

Perform oligonucleotide synthesis, purification, and analytical testing (especially HPLC); maintain lab notebooks and inventory; track project timelines and communicate status; follow safe lab practices.

Perform routine QC analytical testing (raw materials, in-process, drug substance/product, stability) and Environmental Monitoring within cGMP. Operate and troubleshoot instrumentation (HPLC, GC, FT-IR, UV/Vis, KF), maintain records, support GLP toxicology and clinical material release, follow SOPs, assist investigations (OOS/atypical), and collaborate on lab tasks with minimal supervision.

Support month- and quarter-end close activities, prepare journal entries and balance sheet reconciliations (leases, accruals, clinical trial items), perform variance analysis, assist SEC reporting (10-Q/10-K) and audits, update accounting policies, and collaborate cross-functionally to support estimates and SOX compliance.

Lead a team developing scalable oligonucleotide manufacturing processes, including solid-phase synthesis, downstream processing, scale-up, process improvements, troubleshooting, analytical characterization, and technology transfer to support clinical candidates and manufacturing.

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.

Support implementation, monitoring, and maintenance of security controls across endpoints, identity, and Microsoft 365. Monitor alerts, assist with Intune device compliance and remediation, perform access reviews and MFA support, investigate security issues with IT, document procedures, produce routine reports, and use PowerShell/Intune scripts to automate tasks under senior guidance.

Design and maintain secure endpoint baselines using Intune/Group Policy, triage security alerts, deploy conditional access and MFA, manage EDR/firewall policies, automate with PowerShell, ensure compliance through audits and documentation, and coordinate with IT to reduce risk.

Support GMP quality systems with emphasis on analytical method verification/validation. Provide QA subject-matter expertise, review/approve validation documentation, mentor QA staff, manage deviations/change controls/CAPAs related to validation, and support audits, qualification, and commercial manufacturing continuous process verification.

Lead Quality Assurance initiatives for qualification, cleaning validation, process validation, and continued process verification for commercial GMP manufacturing. Provide SME guidance, draft/review procedures, mentor QA staff, support deviations/change controls/CAPAs, review vendor/internal validation data, assist audits and registration batch reviews.

Support and manage QMS change control for preclinical, clinical, and commercial programs. Facilitate change requests, CCB meetings, risk assessments, effectiveness checks, metrics, training, audits, and continuous improvement of change management processes.

Manage provider accounts and patient cases to advance access and reimbursement for Redemplo. Provide reimbursement education, resolve complex coverage issues, coordinate with HUB/specialty pharmacy, support enrollment/appeals/prior authorizations, develop territory plans, document interactions, and ensure compliance with company policies and regulations.

Support Translational Biomarkers projects by coordinating clinical sample shipments, maintaining a compliant biorepository and ELN/LIMS workflows, ensuring regulatory compliance and patient privacy, assisting clinical sample processing and reagent procurement, maintaining documentation and vendor logs, and facilitating team communication and coordination.

Lead brand strategy and launch execution for Plozasiran, building and managing a high-performing marketing team. Drive positioning, omnichannel campaigns, HCP and patient messaging, agency relationships, budgets, market insights, and cross-functional alignment with Medical Affairs, Market Access, and Sales to achieve launch objectives.

Support end-to-end biweekly and off-cycle payroll processing and day-to-day benefits administration. Administer equity compensation transactions and maintain equity filing systems. Audit payroll and employee changes, provide benefits and system support, drive process improvements, and assist broader People Services & Culture tasks in a fast-paced, compliance-focused environment.

Manage clinical quality documents within the eQMS, coordinating development, review, approval, and retirement of SOPs, work instructions, templates, and forms. Ensure documents comply with GCP/ICH/GVP/GLP and regulatory expectations, drive cross-functional review workflows, maintain inspection readiness, produce document KPIs, support eQMS (Veeva) enhancements, and liaise between Clinical Development and QA to improve document processes and system functionality.

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

Provide transactional and corporate legal counsel for a biopharmaceutical company, drafting and negotiating agreements, supporting diligence and securities filings, leading governance, advising on privacy/AI/securities/commercialization, and assisting with employment, real estate, compliance, investigations, and litigation as needed.

Lead delivery and continuous improvement of Dynamics 365 Finance & Operations for Finance, Procurement, AP/AR, Fixed Assets, PMA, and Cost Management. Act as primary IT liaison to Finance, design solutions and integrations, govern vendors, ensure compliance (SOX, 21 CFR Part 11, CSA), support audits, and develop team members while driving roadmap, process improvements, and Power BI reporting.

Independently review and evaluate analytical laboratory data and documentation for accuracy, completeness, and GMP compliance. Investigate and document discrepancies, review release/stability/validation data, support audit and inspection readiness, collaborate with labs and CDMOs, recommend process improvements, and mentor junior reviewers.

Support eQMS workflows for product complaints and quality events; conduct investigations, root cause analysis, CAPA assessment, tracking/trending, and audit support. Review/approve quality events and procedures and present quality metrics to stakeholders while ensuring regulatory compliance.