Associate Director, External Manufacturing

Location: Verona, Wisconsin, United States.

About the role

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 leader 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. The role works 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. It is an on‑site position with a five‑day‑a‑week office expectation.

Responsibilities

• CDMO Ownership & External Manufacturing Leadership (1–3 Key Partners)
  • Serve as the single point of accountability and primary technical/business interface for assigned CDMOs.
  • Lead joint operating cadences, governance meetings, escalation pathways, and performance reviews.
  • Drive on‑time, in‑full, in‑specification delivery of clinical and commercial supply; monitor KPIs such as yield, cycle time, right‑first‑time, deviation rate, and on‑time release.
  • Lead and approve technology transfers from internal Process Development into the CDMO network.
  • Review and approve batch records, deviations, CAPAs, change controls, investigations, risk assessments, and validation documentation.
  • Develop and execute risk‑mitigation strategies for critical raw materials, secondary sourcing, and capacity contingency.
  • Partner with Procurement and Legal on commercial terms, statements of work, quality agreements, and capacity reservations.
• Cross‑Functional Leadership (Core Competency)
  • Act as the connective tissue between CDMOs and internal Process Development, Analytical Development, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, Program Management, and Clinical Supply.
  • Represent External Manufacturing on cross‑functional program teams; translate program priorities into clear CDMO deliverables and vice‑versa.
  • Lead through influence in a matrixed environment—drive alignment, surface trade‑offs, and resolve conflict without direct authority.
  • Facilitate timely, transparent communication across functions and with CDMO partners.
  • Anticipate and remove cross‑functional roadblocks; proactively manage handoffs to keep manufacturing campaigns on track.
  • Build coalitions around supply strategy, risk decisions, and continuous‑improvement initiatives.
• Platform‑Based CMC & Technical Oversight
  • Provide technical oversight of solid‑phase oligonucleotide synthesis, purification (HPLC, TFF/UF‑DF), lyophilization, and related unit operations at assigned CDMOs.
  • Oversee ligand conjugation processes (e.g., GalNAc) and other targeted delivery chemistries executed externally.
  • Support drug product formulation, sterile filtration, fill‑finish, and stability programs at partners.
  • Ensure CDMO operations align with platform scalability, comparability, and lifecycle‑management goals.
  • Maintain rigorous control of critical quality attributes (CQAs) such as oligonucleotide purity, impurity profiles, residual solvents, conjugation efficiency, potency, and stability.
• Clinical‑to‑Commercial Readiness
  • Lead process performance qualification (PPQ), validation, and commercial supply readiness activities at assigned CDMOs.
  • Support comparability assessments for process changes, site transfers, or scale increases.
  • Partner with Supply Chain on demand planning, capacity modeling, and S&OP execution.
  • Drive cost‑of‑goods optimization and continuous‑improvement initiatives to support long‑term commercial strategy.
• Regulatory & Quality Interface
  • Contribute to CMC sections for INDs, CTAs, BLAs/NDAs, and global regulatory submissions related to assigned CDMOs and products.
  • Support regulatory agency interactions, pre‑approval inspections, and ongoing inspection readiness at external manufacturing sites.
  • Partner with Quality Assurance on quality agreements, audit programs, and remediation planning.
  • Champion a culture of compliance, data integrity, and continuous improvement across the external manufacturing network.

Requirements

• PhD, MS, or BS in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related discipline.
• 8+ years of experience in biopharmaceutical technical operations, external manufacturing, or CMC (less if PhD).
• Demonstrated success managing CDMO relationships as the primary technical/business owner, including technology transfer, GMP manufacturing oversight, and performance management.
• Direct experience with synthetic oligonucleotide (siRNA or ASO) manufacturing; experience with GalNAc conjugates or other targeted RNA delivery technologies strongly preferred.
• Proven ability to lead and influence in a highly matrixed, cross‑functional environment spanning PD, AD, Quality, Regulatory, and Supply Chain.
• Experience supporting late‑stage clinical programs and/or commercial launches, including PPQ and BLA/NDA‑supporting activities.
• Strong working knowledge of FDA, EMA, and ICH GMP requirements; experience supporting regulatory inspections at CDMOs.
• Excellent written and verbal communication skills, with the ability to translate technical detail into executive‑level recommendations.
• Ability to lead and coordinate large, complex strategy projects with minimal direction (preferred).
• Experience developing operations‑network strategies for a growing global market (preferred).
• Current, valid authorization to work in the United States.

Pay

Wisconsin pay range: $150,000 — $170,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.