Director, Drug Product Development, Sterile Products

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 mentor a high-performing sterile drug product development team.
• Manage development budgets, timelines, and resources across multiple sterile and ASO programs.
• Promote a culture of scientific rigor, compliance, accountability, and continuous improvement.

Required Qualifications

Education: PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline OR MS with significant relevant industry experience.

Experience: 10+ years of pharmaceutical development experience, with 5+ years in a leadership role. Demonstrated experience leading sterile drug product development, including antisense oligonucleotide (ASO) products, from early phase through commercialization. Strong experience working with aseptic manufacturing and fill-finish CDMOs, including oligonucleotide-capable facilities. Proven support of IND/NDA filings and regulatory inspections for sterile products.

Technical Expertise: Deep expertise in sterile formulation and aseptic process development. Experience with ASO drug product development, including formulation stability, degradation pathways, and parenteral delivery. Strong understanding of lyophilization, filtration, filling, CCI, and aseptic controls. Solid knowledge of GMPs, ICH guidance, and regulatory expectations for sterile and oligonucleotide products. Experience supporting global submissions (US, EU, Japan, emerging markets) for ASO products. Experience with post-approval changes, comparability, and site transfers for sterile injectables. Experience with commercial aseptic operations and cost-of-goods optimization.

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.