Director, Drug Product Development, Sterile Products

Otsuka Pharmaceutical Co., Ltd.

13d•$186,489 - $278,875

About The Position

The Director, Drug Product Development – Sterile Products provides strategic and technical leadership for sterile drug product development across clinical and commercial stages, with a focus on small-molecule sterile injectables and antisense oligonucleotide (ASO) products. The role oversees formulation and aseptic process development, scale-up, validation, and lifecycle management, primarily through external CDMOs. It establishes phase-appropriate strategies that meet global regulatory expectations and support reliable clinical and commercial supply. The Director serves as a sterile and ASO drug product subject matter expert and works closely with Quality, Regulatory Affairs, Analytical Development, MSAT, and Supply Chain to support compliance, inspection readiness, and operational excellence. The role also leads and mentors a development team and manages budgets, timelines, and resources across multiple programs.

Requirements

PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline, or a master's degree with significant relevant industry experience.
10 or more years of pharmaceutical development experience.
5 or more years in a leadership role.
Demonstrated experience leading sterile drug product development, including 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.
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, container–closure integrity, and aseptic controls.
Solid knowledge of GMPs, ICH guidance, and regulatory expectations for sterile and oligonucleotide products.
Experience supporting global submissions for ASO products in the US, EU, Japan, and emerging markets.
Experience with post-approval changes, comparability, and site transfers for sterile injectables.
Experience with commercial aseptic operations and cost-of-goods optimization.
Demonstrate accountability for results, strategic thinking and problem-solving, patient and customer centricity, impactful communication, respectful collaboration, and commitment to professional development.

Responsibilities

Lead 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 on cross-functional program teams and governance forums.
Provide technical leadership on formulation design, aseptic processing, and control strategies for oligonucleotide-based products.
Lead development of sterile injectable solutions, suspensions, and lyophilized dosage forms for small molecules and ASOs.
Oversee formulation robustness, ASO stability, excipient compatibility, and container–closure interactions.
Drive development and optimization of aseptic manufacturing processes, including filtration, filling, and lyophilization cycles.
Lead selection and qualification of vials, stoppers, prefilled syringes, and cartridges.
Oversee container–closure integrity strategies, compatibility, and extractables/leachables assessments.
Develop product presentation strategies suitable for clinical and commercial use.
Lead clinical-to-commercial scale-up, aseptic process simulations (media fills), and robustness studies.
Oversee process performance qualification, continued process verification, and post-approval lifecycle management.
Ensure sterile and ASO drug product readiness for global commercial launch and sustained supply.
Select, onboard, and manage sterile formulation and fill-finish CDMOs, including partners capable of handling oligonucleotides.
Lead technology transfers for ASO and small-molecule sterile products, including site changes and secondary sourcing.
Establish technical governance models and development plans with external partners.
Provide sterile and ASO drug product CMC input for IND, NDA, and global regulatory submissions, including Module 3.2.P.
Support health authority interactions, requests for information, inspections, and audits, particularly for aseptic processing and oligonucleotide-specific controls.
Ensure compliance with GMPs, ICH guidelines, and global regulatory expectations for sterile and ASO products.
Partner with Analytical Development and QC on methods, specifications, stability programs, and ASO impurity control strategies.
Collaborate with Quality on aseptic compliance, deviation management, and inspection readiness.
Work with MSAT and Supply Chain to support reliable clinical and commercial sterile supply.
Lead and mentor a high-performing sterile drug product development team.
Manage development budgets, timelines, and resources across multiple sterile and ASO programs.
Promote scientific rigor, compliance, accountability, and continuous improvement.