Senior Director, Small Molecule API Development - Remote

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

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Small Molecule Drug Substance Development to provide strategic, scientific, and operational leadership for API development from candidate nomination through commercial readiness.

You will lead a team of scientists and process chemists in a fully virtual model, partnering with CDMOs to ensure robust, scalable, and compliant manufacturing. The role drives development strategies, regulatory submissions, portfolio planning, risk mitigation,

Qualifications

• 15+ years in pharmaceutical or biotech drug substance development.
• Led small molecule process chemistry and API development.
• 5+ years leading scientific teams.
• Proven success advancing programs through late-stage development.
• Experience managing CDMOs and external partners.

Responsibilities

• Lead drug substance development strategy and API plans.
• Oversee CDMO selection, technology transfer, and scale-up.
• Provide regulatory strategy and support regulatory filings.
• Develop and mentor a high-performing team.
• Manage department budgets and resources.

Skills

Strategic thinking

Scientific leadership

Project management

Budget management

Cross-functional leadership

Team leadership

Education

PhD in Organic Chemistry

Master's degree considered

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Small Molecule Drug Substance Development to provide strategic, scientific, and operational leadership for API development from candidate nomination through commercial readiness.

You will lead a team of scientists and process chemists in a fully virtual model, partnering with CDMOs to ensure robust, scalable, and compliant manufacturing. The role drives development strategies, regulatory submissions, portfolio planning, risk mitigation,