Remote Senior Director, Small Molecule API Development

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) with match

Tuition reimbursement

Paid holidays and PTO

Job summary

Otsuka America Pharmaceutical, Inc. seeks a Senior Director of Small Molecule Drug Substance Development to lead strategies for API development from candidate nomination to commercial readiness. You will guide process chemistry, scale-up, and manufacturing strategy while managing CDMOs in a fully remote model.

The role requires 15+ years in pharma/biotech drug substance development with strong leadership and regulatory experience. Competitive pay and global responsibility are offered.

Qualifications

• PhD in Organic Chemistry, Process Chemistry, Chemical Engineering or related field preferred.
• Master's degree with significant industry experience may be considered.
• 15+ years in pharmaceutical or biotech drug substance development.
• Minimum 5 years leading scientific teams and managing people.
• Proven success advancing multiple small molecule programs to commercialization.
• Extensive experience with CDMOs, external partners, and tech transfer.

Responsibilities

• Develop phase-appropriate drug substance development strategies.
• Lead API development plans aligned with program objectives.
• Provide leadership in route selection, process optimization, and scale-up.
• Drive robust, scalable, compliant manufacturing processes.
• Oversee regulatory submissions for drug substance sections.
• Partner with cross-functional teams to align program goals.
• Mentor and develop a high-performing technical team.
• Oversee budget and external development expenditures.

Skills

Process chemistry

API development

Team leadership

CDMO management

Regulatory strategy

Scale-up

Education

PhD in Organic Chemistry

Master's degree (relevant)

Tools

Regulatory guidelines

Job description

Otsuka America Pharmaceutical, Inc. seeks a Senior Director of Small Molecule Drug Substance Development to lead strategies for API development from candidate nomination to commercial readiness. You will guide process chemistry, scale-up, and manufacturing strategy while managing CDMOs in a fully remote model.

The role requires 15+ years in pharma/biotech drug substance development with strong leadership and regulatory experience. Competitive pay and global responsibility are offered.