Associate Director, External Manufacturing
Arrowhead PharmaceuticalsAbout the role
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops 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. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Associate Director, External Manufacturing will serve as Arrowhead's primary technical and operational owner for a focused portfolio of 1–3 strategic Contract Development and Manufacturing Organizations (CDMOs) supporting the manufacture of siRNA-based therapeutics. This individual will be accountable for end-to-end CDMO relationship management, technology transfer, GMP supply, and lifecycle performance for drug substance (oligonucleotide synthesis and conjugation), targeted delivery components (e.g., GalNAc and other ligand systems), and/or drug product manufacturing operations.
Operating as the single point of accountability for assigned CDMO partners, this leader will work seamlessly across Process Development, Analytical Development, Quality, Regulatory, Supply Chain, Program Management, and Clinical Operations to ensure robust, compliant, predictable, and cost-effective supply of clinical and commercial product. The successful candidate is, above all, a highly effective cross-functional leader — someone who builds trust quickly, drives alignment among diverse stakeholders, and converts technical complexity into clear decisions and forward momentum.
This role plays a critical part in scaling Arrowhead's platform-enabled RNAi candidates from development through late-stage clinical and commercial readiness, while supporting global regulatory filings and inspection readiness.
This position is approved at the Associate Director level. Candidates with significantly greater depth of relevant experience, demonstrated leadership of complex external manufacturing programs, and a track record of successfully managing late-stage or commercial CDMO partnerships may be considered at the Director level. Final leveling will be based on experience and qualifications.
This role is based in onsite with an expectation to be in the office five days a week.
Responsibilities
CDMO Ownership & External Manufacturing Leadership (1–3 Key Partners)
- Serve as the single point of accountability and primary technical/business interface for an assigned portfolio of 1–3 strategic CDMOs supporting drug substance, conjugation, and/or drug product manufacturing.
- Own the day-to-day operational relationship: lead joint operating cadences, governance meetings, escalation pathways, and performance reviews; cultivate strong, trust-based partnerships with CDMO leadership and technical teams.
- Drive on-time, in-full, in-specification delivery of clinical and commercial supply; monitor and report key performance indicators including yield, cycle time, right-first-time, deviation rate, and on-time release.
- Lead and approve technology transfers from internal Process Development into the assigned CDMO network, ensuring readiness, documentation, and successful demonstration runs.
- Review and approve batch records, deviations, CAPAs, change controls, investigations, risk assessments, and validation documentation generated at assigned CDMOs.
- Develop and execute risk mitigation strategies for critical raw materials (phosphoramidites, linkers, solid supports, excipients), secondary sourcing, and capacity contingency.
- Partner with Procurement and Legal on commercial terms, statement
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