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Director, Drug Product Development – Sterile Products
Otsuka Pharmaceutical Companies (U.S.). Lead strategic and technical sterile drug product development across clinical and commercial lifecycles .
About the role
Key responsibilities & impact- Lead strategic and technical sterile drug product development across clinical and commercial lifecycles
- Execute sterile drug product strategies for small-molecule and ASO programs aligned with CMC, clinical, and commercial objectives
- Serve as sterile drug product subject matter expert on cross-functional program teams and governance forums
- Provide technical leadership on formulation design, aseptic processing approaches, and control strategies
- Lead development of sterile injectable liquids, suspensions, and lyophilized dosage forms
- Oversee formulation robustness, ASO stability, excipient compatibility, and container-closure interactions
- Drive aseptic manufacturing process development and optimization, 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
- Lead clinical-to-commercial scale-up, aseptic process simulations, and robustness studies
- Oversee process performance qualification, continued process verification, and post-approval lifecycle management
- Ensure readiness for global commercial launch and sustained supply
- Select, onboard, and manage sterile formulation and fill-finish CDMOs
- Lead technology transfers, site changes, and secondary sourcing
- Establish technical governance models and development plans with external partners
- Provide CMC input for IND, NDA, and global regulatory submissions
- Support health authority interactions, requests for information, inspections, and audits
- Ensure compliance with GMPs, ICH guidelines, and global regulatory expectations
- Partner with Analytical Development/QC on methods, specifications, stability programs, and impurity control strategies
- Collaborate with Quality on aseptic compliance, deviation management, and inspection readiness
- Work with MSAT and Supply Chain to ensure 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 programs
- Promote scientific rigor, compliance, accountability, and continuous improvement
Requirements
What you’ll need- PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline OR MS with significant relevant industry experience
- 10+ years of pharmaceutical development experience
- 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
- 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 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
- Ability to demonstrate accountability, strategic thinking, problem solving, patient and customer centricity, impactful communication, respectful collaboration, and empowered development
Benefits
Comp & perks- Comprehensive medical, dental, vision, and prescription drug coverage
- Company-provided basic life insurance
- Accidental death and dismemberment insurance
- Short-term and long-term disability insurance
- Tuition reimbursement
- Student loan assistance
- Generous 401(k) match
- Flexible time off
- Paid holidays
- Paid leave programs
- Other company-provided benefits
- Incentive opportunity