Associate Director, External Manufacturing

Responsibilities:

• Serve as single point of accountability and primary technical/business interface for 1–3 strategic CDMOs supporting drug substance, conjugation, and/or drug product manufacturing.
• Lead day-to-day CDMO operations: joint operating cadences, governance meetings, escalation pathways, and performance reviews; build trust with CDMO leadership/technical teams.
• Drive on-time, in-full, in-specification delivery of clinical and commercial supply; monitor KPIs (yield, cycle time, right-first-time, deviation rate, on-time release).
• Lead and approve technology transfers from internal Process Development into assigned CDMOs.
• Review/approve batch records, deviations, CAPAs, change controls, investigations, risk assessments, and validation documentation from CDMOs.
• Develop/execute risk mitigation 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 across PD, Analytical Development, Quality, Regulatory, Supply Chain, Program Management, and Clinical Supply; translate program priorities into CDMO deliverables and resolve issues in a matrixed environment.
• Provide technical oversight of solid-phase oligonucleotide synthesis, purification (HPLC, TFF/UF-DF), lyophilization, ligand conjugation (e.g., GalNAc), and related unit operations.
• Support drug product formulation, sterile filtration, fill‑finish, and stability.
• Lead PPQ, validation, and commercial supply readiness; support comparability assessments; partner on demand planning/capacity modeling/S&OP; drive cost‑of‑goods optimization.
• Contribute CMC sections (IND/CTA/BLA/NDA) and support regulatory interactions, pre‑approval inspections, and inspection readiness; partner with QA on quality agreements/audits.

• PhD, MS, or BS in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field.
• 8+ years (or less with PhD) in biopharmaceutical technical operations/external manufacturing/CMC with progressive responsibility.
• Proven experience managing CDMO relationships as primary technical/business owner (technology transfer, GMP oversight, performance management).
• Required:
  
  synthetic oligonucleotide (siRNA or ASO) manufacturing experience; strong preference for GalNAc conjugates/targeted RNA delivery technologies.
• Ability to lead/influence in a cross‑functional, matrixed environment (PD, AD, Quality, Regulatory, Supply Chain).
• Experience supporting late‑stage clinical programs/commercial launches (PPQ; BLA/NDA‑supporting activities).
• Strong working knowledge of FDA/EMA/ICH GMP and supporting regulatory inspections at CDMOs.
• Excellent written/verbal communication; translate technical detail into executive recommendations.

• Lead complex strategy projects with minimal direction.
• Experience developing operations network strategies for a growing global market.

Based onsite; expected in office five days a week.