Remote Senior Director, Small Molecule API Development

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid holidays and leave

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a Senior Director to lead small molecule drug substance development from candidate nomination to commercial readiness.

The role directs teams of scientists and process chemists, driving strategy, process optimization, and scalable manufacturing solutions in a fully virtual model. You will collaborate with global partners, manage CDMOs, and contribute to portfolio planning and regulatory submissions.

Qualifications

• 15+ years in pharmaceutical/biotech drug substance development.
• Leadership experience in small molecule process chemistry and API development.
• 5+ years leading scientific teams and managing people.
• Proven success advancing multiple small molecule programs to late-stage development and commercial readiness.
• Experience managing CDMOs and external development partners.

Responsibilities

• Develop and execute phase-appropriate drug substance development strategies from nomination through commercial readiness.
• Lead strategy for API development plans aligned with program objectives.
• Provide leadership in route selection, process chemistry, optimization, impurity control, scale-up, and manufacturing strategy.
• Drive development of robust, scalable, and cost-effective manufacturing processes.
• Oversee regulatory documentation and health authority interactions for CMC submissions.
• Lead technology transfer, scale-up, and manufacturing activities with CDMOs.
• Mentor and develop a high-performing team of chemists and scientists.

Skills

Strategic leadership

Team leadership

Process chemistry

API development

Regulatory strategy

CDMO management

Education

PhD in Organic Chemistry

MS with significant industry experience

Tools

External manufacturing partnerships

Job description

Otsuka America Pharmaceutical, Inc. is seeking a Senior Director to lead small molecule drug substance development from candidate nomination to commercial readiness.

The role directs teams of scientists and process chemists, driving strategy, process optimization, and scalable manufacturing solutions in a fully virtual model. You will collaborate with global partners, manage CDMOs, and contribute to portfolio planning and regulatory submissions.