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Jobs · Quality Assurance · Wisconsin

Senior Manager, Global Sample Stability and Retains Program

Arrowhead Pharmaceuticals · Madison, WI · 1 wk ago
On-siteQuality Assurance$140k/yrFull-time

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing 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. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins. Arrowhead’s RNAi-based therapeutics leverage the natural pathway of gene silencing, enabling the potential to address conditions across virtually any therapeutic area.

The corporate headquarters is in Pasadena, CA, with research and development teams in Madison, WI, and San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI.

About the role

The Senior Manager will lead the Global Sample Stability and Retains Program within the Quality Control unit in the Quality organization, based at the Arrowhead Verona site. This role is responsible for the strategic design, implementation, and oversight of stability programs, global retain sample management, and reference standard lifecycle management across all phases of development and commercial operations.

Responsibilities

  • Establish and manage a compliant global stability and retain sample program (raw materials, drug substance, drug product, and finished goods) per US 21 CFR 211.170, EU GMP Annex 19, and other applicable regional regulations, including defined sample quantities, storage conditions, retention periods, and inventory/chain-of-custody/disposition management.
  • Develop, review, and approve stability protocols, study designs, and commitments per ICH Q1A(R2), Q1E, Q5C, and regional guidance; ensure all stability studies (long-term, accelerated, intermediate, in-use, photostability, thermal cycling, transportation/excursion) are executed on schedule across internal labs and external CMOs/CTLs.
  • Oversee stability data trending and statistical analysis (regression, pooling, out-of-trend evaluation) to support shelf-life/retest date determination and justifications for regulatory filings (INDs, NDAs, BLAs, MAAs, and global equivalents), including leading shelf-life extension activities.
  • Support annual product stability reviews, APQR/PQR, and stability commitment tracking; manage stability chamber qualification, monitoring, and excursion investigations with Facilities/Engineering.
  • Own the end-to-end reference standard lifecycle program — selection, qualification, characterization, stability monitoring, inventory, and distribution across internal sites, CMOs, and CTLs.
  • Directly manage, mentor, and develop a team of stability and retain professionals, including hiring, performance management, training, and career development.
  • Support regulatory submissions and health authority information requests related to stability and retains.
  • Other duties as assigned.

Requirements

  • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline required; advanced degree (MS) preferred.
  • Minimum 8–10 years of experience in pharmaceutical/biotech Quality Assurance, Quality Control, or CMC, with significant direct experience in global stability program management and retain sample management.
  • Minimum 3–5 years of people management experience, with demonstrated ability to lead, develop, and grow a team.
  • Experience supporting both clinical (IND-stage) and global commercial products preferred.
  • Prior experience with RNAi, oligonucleotide, biologics, or complex/novel modality products is a plus.
  • Expert working knowledge of global stability and retains regulations and guidance, including US FDA 21 CFR 211, EU GMP Annex 19, ICH Q1A(R2)/Q1E/Q5C, UK MHRA, Japan PMDA, Australia TGA, and Health Canada requirements.

Qualifications

  • Master of Science Degree in Chemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline.
  • Strong understanding of stability study design, statistical trending, shelf-life extrapolation, and regulatory submission requirements.
  • Demonstrated experience managing global retain sample programs across multiple markets and distribution channels.
  • Experience hosting and supporting regulatory inspections (FDA, EMA, MHRA, PMDA, TGA) and third-party audits.
  • Hands-on experience using LIMS (Laboratory Information Management System) for stability sample scheduling, pull-point tracking, test result entry, and stability data trending; experience configuring or administering stability modules within a LIMS strongly preferred.
  • Demonstrated experience with data trending techniques (e.g., linear regression, pooling analysis, out-of-trend/out-of-specification evaluation) used to support shelf-life determination and shelf-life extension justifications.
  • Demonstrated experience managing reference standard lifecycle activities, including selection, qualification, stability monitoring, inventory management, and global distribution.
  • Strong project management skills with the ability to manage multiple studies, timelines, and priorities simultaneously.
  • Excellent written and verbal communication skills; experience authoring SOPs, technical reports, and regulatory documentation.
  • Demonstrated leadership, coaching, and team-building skills.
  • Ability to work effectively in a fast-paced, growing biopharmaceutical environment with evolving priorities.

Pay

Wisconsin pay range: $140,000 USD - $160,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

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