Remote Senior Director, Small Molecule API Development

Otsuka America Pharmaceutical Inc.; Hagåtña (GU); Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical, Inc. seeks a Senior Director of Small Molecule Drug Substance Development to lead strategy, science, and operations from candidate nomination through commercial readiness.

You will guide process chemistry, scale-up, and CDMO partnerships in a fully virtual model while ensuring regulatory compliance and cost efficiency. The role requires 15+ years in drug substance development, strong leadership of scientific teams, and a track record of advancing programs through

Qualifications

• PhD in Organic Chemistry or related field preferred; MS with substantial industry experience considered.
• 15+ years in pharma/biotech drug substance development; leadership in small molecule APIs.

Responsibilities

• Develop and execute phase-appropriate drug substance development strategies from candidate nomination through commercial readiness.
• Lead API development plans aligned with program, portfolio, and corporate objectives.
• Provide scientific leadership in route selection, process chemistry, scale-up, and manufacturing strategy.
• Oversee risk identification and mitigation to support timelines and objectives.
• Manage CDMOs and external partners to ensure qualified development and transfer activities.

Skills

Leadership

Drug substance development

Process chemistry

CDMO management

Regulatory strategy

Cross-functional collaboration

Strategic planning

Education

PhD in Organic Chemistry

Master's degree with significant industry experience

Tools

CDMO management tools

Job description

Otsuka America Pharmaceutical, Inc. seeks a Senior Director of Small Molecule Drug Substance Development to lead strategy, science, and operations from candidate nomination through commercial readiness.

You will guide process chemistry, scale-up, and CDMO partnerships in a fully virtual model while ensuring regulatory compliance and cost efficiency. The role requires 15+ years in drug substance development, strong leadership of scientific teams, and a track record of advancing programs through