Director, Sterile Drug Product Development & ASO

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Director, Drug Product Development – Sterile Products to lead sterile drug product development across clinical and commercial lifecycles, with emphasis on small molecule sterile injectables and ASO products. You will oversee formulation development, aseptic process development, scale-up, validation, and lifecycle management, often through external CDMOs.

You will partner with Quality, Regulatory Affairs, Analytical Development, MSAT, and Supply Chain

Qualifications

• PhD or MS with extensive relevant experience in sterile drug product development.
• 10+ years in pharma development with 5+ years in a leadership role.
• Experience leading sterile drug product development including ASO products and working with aseptic manufacturing CDMOs.

Responsibilities

• Lead sterile drug product development strategies for small molecule and ASO programs.
• Serve as sterile drug product SME on cross‑functional program teams and governance forums.
• Provide technical leadership on formulation design, aseptic processing approaches, and control strategies for oligonucleotide-based products.
• Lead development of sterile injectables including liquid solutions, suspensions, and lyophilized dosage forms.
• CDMO oversight and technology transfer for ASO and small‑molecule sterile products.

Skills

Sterile formulation

Aseptic process development

ASO program leadership

CDMO oversight

Education

PhD in Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering/C Chemistry

MS with significant industry experience

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a Director, Drug Product Development – Sterile Products to lead sterile drug product development across clinical and commercial lifecycles, with emphasis on small molecule sterile injectables and ASO products. You will oversee formulation development, aseptic process development, scale-up, validation, and lifecycle management, often through external CDMOs.

You will partner with Quality, Regulatory Affairs, Analytical Development, MSAT, and Supply Chain