The PositionThe Senior Manager will lead the Global Sample Stability and Retains Program within the Quality Control unit in the Quality organization, based on site 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. The successful candidate will bring deep expertise in global quality and regulatory requirements (FDA, EMA, MHRA, PMDA, TGA, Health Canada, and other applicable health authorities) for stability and retain management and will lead a team responsible for ensuring compliant, audit-ready stability, retains, and reference standard operations across Arrowhead's global network of internal sites, CMOs, and CTLs.
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 (UK MHRA, Japan PMDA, Australia TGA, etc.), including defined sample quantities, storage conditions, retention periods, and inventory/chain-of-custody/disposition management, coordinated with international distribution and regulatory affairs for country-specific requirements.
- 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 (protocol development, data packages, statistical justification, and coordination with Regulatory Affairs for submissions).
- 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 - including qualification protocols/reports with acceptance criteria and traceability to primary/compendial standards, and timely requalification/replacement ahead of expiry (including bridging studies between lots).
- Support regulatory submissions and health authority information requests related to stability and retains.
- Directly manage, mentor, and develop a team of stability and retain professionals, including hiring, performance management, training, and career development.
- 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.
Preferred: - Masters 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.
Wisconsin pay range
$140,000-$160,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
