Associate Director Validation Jobs in Watertown, WI

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, statements of work, quality agreements, and capacity reservations for assigned CDMOs.

 Cross-Functional Leadership (Core Competency)

• Act as the connective tissue between assigned CDMOs and Arrowhead's internal Process Development, Analytical Development, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, Program Management, and Clinical Supply functions.
• Represent External Manufacturing on cross-functional program teams; translate program priorities into clear CDMO deliverables and translate CDMO realities into actionable internal decisions.
• Lead through influence in a matrixed environment — drive alignment, surface trade-offs, and resolve conflict without relying on direct authority.
• Facilitate timely, transparent communication across functions and with CDMO partners; ensure stakeholders have the information they need to make sound, fast decisions.
• Anticipate and remove cross-functional roadblocks; proactively manage handoffs between PD, AD, QA, Regulatory, and Supply Chain to keep manufacturing campaigns on track.
• Build coalitions around supply strategy, risk decisions, and continuous improvement initiatives; ensure every functional voice is represented and heard.

 Platform-Based CMC & Technical Oversight

• Provide technical oversight of solid-phase oligonucleotide synthesis, purification (HPLC, TFF/UF-DF), lyophilization, and associated unit operations at assigned CDMOs.
• Oversee ligand conjugation processes (e.g., GalNAc) and/or other targeted delivery chemistries executed externally.
• Support drug product formulation, sterile filtration, fill-finish, and stability programs at assigned partners.
• Ensure assigned CDMO operations align with platform scalability, comparability, and lifecycle management goals.
• Maintain rigorous control of critical quality attributes (CQAs), including oligonucleotide purity and impurity profiles (n-1, n+1 species), residual solvents and reagents, 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 for a growing pipeline.
• Drive cost-of-goods optimization and continuous improvement initiatives in partnership with assigned CDMOs 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 assigned external manufacturing sites.
• Partner with Quality Assurance on quality agreements, audit programs, and remediation planning for assigned CDMOs.
• Champion a culture of compliance, data integrity, and continuous improvement across the external manufacturing network.

Requirements

• PhD., M.S., or B.S. in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline.
• 8+ years of experience in biopharmaceutical technical operations, external manufacturing, or CMC, with progressive responsibility (less if Ph.D.).
• Demonstrated success directly 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 required; 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.

Preferred

• Able to lead and coordinate large, complex strategy projects, with minimal direction
• Experience developing operations network strategies for a growing global market