Senior Manager, Global Sample Stability and Retains Program
Arrowhead Pharmaceuticals
August 14, 2026
On-site
Madison, WI
Operations
Responsibilities:
- Establish and manage a compliant global stability and retain sample program (raw materials, drug substance, drug product, finished goods) per US 21 CFR 211.170, EU GMP Annex 19, and regional regulations, including sample quantities, storage, retention periods, and inventory/chain-of-custody/disposition management.
- Develop, review, and approve stability protocols/study designs/commitments per ICH Q1A(R2), Q1E, Q5C and regional guidance; ensure 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 to support shelf-life/retest date determinations and regulatory filing justifications; lead shelf-life extension activities.
- Support annual product stability reviews (APQR/PQR), stability commitment tracking, and stability chamber qualification/monitoring and excursions.
- Own end-to-end reference standard lifecycle program (selection, qualification, characterization, stability monitoring, inventory, distribution); manage requalification/replacement and bridging between lots.
- Support regulatory submissions and health authority information requests related to stability and retains.
- Directly manage, mentor, and develop a stability and retain team (hiring, performance management, training, career development).
Requirements:
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or related field (MS preferred).
- 8–10+ years in pharma/biotech Quality Assurance/Quality Control/CMC with global stability program and retain sample management.
- 3–5+ years people management experience.
- Experience with clinical (IND-stage) and global commercial products preferred.
- Plus: RNAi/oligonucleotide/biologics/novel modality experience.
- Expert knowledge of global stability and retain regulations/guidance (FDA 21 CFR 211, EU GMP Annex 19, ICH Q1A(R2)/Q1E/Q5C, MHRA, PMDA, TGA, Health Canada).
Preferred:
- LIMS experience (stability scheduling, pull-point tracking, data trending; administering stability modules).
- Strong stability study design, statistical trending, shelf-life extrapolation; regulatory inspection/audit experience.
Application:
- Candidates must have current, valid authorization to work in the country where this role is located.
- Establish and manage a compliant global stability and retain sample program (raw materials, drug substance, drug product, finished goods) per US 21 CFR 211.170, EU GMP Annex 19, and regional regulations, including sample quantities, storage, retention periods, and inventory/chain-of-custody/disposition management.
- Develop, review, and approve stability protocols/study designs/commitments per ICH Q1A(R2), Q1E, Q5C and regional guidance; ensure 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 to support shelf-life/retest date determinations and regulatory filing justifications; lead shelf-life extension activities.
- Support annual product stability reviews (APQR/PQR), stability commitment tracking, and stability chamber qualification/monitoring and excursions.
- Own end-to-end reference standard lifecycle program (selection, qualification, characterization, stability monitoring, inventory, distribution); manage requalification/replacement and bridging between lots.
- Support regulatory submissions and health authority information requests related to stability and retains.
- Directly manage, mentor, and develop a stability and retain team (hiring, performance management, training, career development).
Requirements:
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or related field (MS preferred).
- 8–10+ years in pharma/biotech Quality Assurance/Quality Control/CMC with global stability program and retain sample management.
- 3–5+ years people management experience.
- Experience with clinical (IND-stage) and global commercial products preferred.
- Plus: RNAi/oligonucleotide/biologics/novel modality experience.
- Expert knowledge of global stability and retain regulations/guidance (FDA 21 CFR 211, EU GMP Annex 19, ICH Q1A(R2)/Q1E/Q5C, MHRA, PMDA, TGA, Health Canada).
Preferred:
- LIMS experience (stability scheduling, pull-point tracking, data trending; administering stability modules).
- Strong stability study design, statistical trending, shelf-life extrapolation; regulatory inspection/audit experience.
Application:
- Candidates must have current, valid authorization to work in the country where this role is located.