Director, Drug Product Development, Sterile Products

The Director, Drug Product Development – Sterile Products is responsible for the strategic and technical leadership of sterile drug product development across the clinical and commercial lifecycle, with emphasis on small molecule sterile injectables and antisense oligonucleotide (ASO) drug products. This role oversees formulation development, aseptic process development, scale up, validation, and lifecycle management for parenteral products, primarily executed through external CDMOs. The Director ensures robust, phase appropriate sterile drug product strategies that meet global regulatory expectations and enable reliable clinical and commercial supply. This role partners closely with Quality, Regulatory Affairs, Analytical Development, MSAT, and Supply Chain to maintain inspection readiness and operational excellence. Key Responsibilities Sterile Drug Product Strategy & Leadership Lead and aseptic execute sterile drug product development strategies for small ‑ molecule and ASO programs , aligned with CMC, clinical, and commercial objectives. Serve as the sterile drug product subject matter expert , including ASO parenteral products, on cross‑functional program teams and governance forums. Provide technical leadership on formulation design, aseptic processing approaches, and control strategies tailored to oligonucleotide‑based products . Formulation & Aseptic Process Development Lead development of sterile injectable products , including liquid solutions, suspensions, and lyophilized dosage forms , for both small molecules and ASOs. Oversee formulation robustness, ASO stability considerations (e.g., degradation pathways, pH, ionic strength) , excipient compatibility, and container–closure interactions. Drive development and optimization of aseptic manufacturing processes , including filtration, filling, and lyophilization cycles appropriate for oligonucleotide drug products . Container–Closure Systems & Product Presentation Lead selection and qualification of vials, stoppers, prefilled syringes, and cartridges for sterile and ASO products. Oversee container–closure integrity (CCI) strategies, compatibility, and extractables/leachables assessments. Ensure robust sterile and ASO product presentation strategies suitable for clinical and commercial use. Scale‑Up, Validation & Commercial Readiness Lead clinical‑to‑commercial scale‑up for sterile and ASO products, including aseptic process simulations (media fills) and robustness studies. Oversee process performance qualification (PPQ) , continued process verification (CPV), and post‑approval lifecycle management. Ensure sterile and ASO drug product readiness for global commercial launch and sustained supply . CDMO Oversight & Technology Transfer Select, onboard, and manage sterile formulation and fill‑finish CDMOs , including those with oligonucleotide handling capabilities . Lead technology transfer activities for ASO and small‑molecule sterile products, including site changes and secondary sourcing. Establish strong technical governance models and development plans with external partners. Regulatory & Compliance Support Provide sterile and ASO drug product CMC input for IND, NDA, and global regulatory submissions (e.g., Module 3.2.P). Support health authority interactions, RFIs, inspections, and audits , with emphasis on aseptic processing and oligonucleotide‑specific controls. Ensure compliance with GMPs, ICH guidelines, and global regulatory expectations for sterile and ASO products. Cross‑Functional Collaboration Partner with Analytical Development/QC to ensure appropriate methods, specifications, stability programs, and impurity control strategies for ASOs. Collaborate with Quality to ensure aseptic compliance, deviation management, and inspection readiness. Work closely with MSAT and Supply Chain to ensure reliable clinical and commercial sterile supply. People, Budget & Program Management Lead and mentora high ‑ performing sterile drug product develop…

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