External Manufacturing Director, RNAi CDMO Partnerships

Arrowhead Pharmaceuticals; Madison (WI); Sur place; USD 130 000 - 195 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Excellent benefits

Résumé du poste

Arrowhead Pharmaceuticals is seeking an Associate Director of External Manufacturing in Madison, WI. You will own the relationship with select CDMOs, drive technology transfers, and manage GMP-compliant supply of clinical and commercial products.

The role requires deep cross-functional leadership across PD, QA, Regulatory, Supply Chain, and Clinical Operations to ensure robust supply, risk mitigation, and cost-effective execution in a fast-paced, regulated environment.

Qualifications

• PhD, MS, or BS in a related science field.
• Demonstrated experience managing external manufacturing relationships (CDMOs).
• Strong knowledge of GMP requirements and regulatory expectations.

Responsabilités

• Act as the primary technical/business owner for 1–3 CDMOs supporting drug substance, conjugation, and/or drug product.
• Lead technology transfers from internal PD to CDMO network and ensure readiness.
• Oversee batch records, deviations, CAPAs, and validation documentation at CDMOs.
• Develop risk mitigation for critical materials and capacity contingency.
• Partner with Legal on terms, quality agreements, and capacity reservations.

Connaissances

CDMO management

GMP knowledge

Cross-functional leadership

Oligonucleotide manufacturing

Regulatory interface

Formation

PhD/MS/B.S. in Chemistry

Description du poste

Arrowhead Pharmaceuticals is seeking an Associate Director of External Manufacturing in Madison, WI. You will own the relationship with select CDMOs, drive technology transfers, and manage GMP-compliant supply of clinical and commercial products.

The role requires deep cross-functional leadership across PD, QA, Regulatory, Supply Chain, and Clinical Operations to ensure robust supply, risk mitigation, and cost-effective execution in a fast-paced, regulated environment.