Director, Drug Product & Process Development (Small Molecules)

Location: Remote within the United States

Salary: $186,489–$278,875 per year, plus incentive opportunity

Company

Otsuka Pharmaceutical Companies develops and commercializes pharmaceutical products and provides comprehensive employee benefits.

What you will do

• Lead late-stage development of oral solid dosage forms, including immediate-, modified-, and extended-release products.
• Finalize formulations and manufacturing processes, including blending, granulation, compression, coating, and encapsulation.
• Lead drug product CMC activities for NDA submissions and support FDA and health authority information requests.
• Direct process characterization, PPQ, continued process verification, scale-up, validation, and technology transfer to commercial sites and CDMOs.
• Provide technical oversight of external manufacturing partners and support launch readiness and reliable supply.
• Lead and mentor scientists and engineers while managing program budgets, outsourcing activities, timelines, and post-approval changes.

Requirements

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline.
• 10–12+ years of experience in oral solid dosage form drug product and process development.
• Experience with late-stage development and at least one NDA submission.
• Experience supporting FDA inspections or pre-approval inspection readiness for oral solid dosage manufacturing sites.
• Strong expertise in formulation, unit operations, QbD, control strategies, process validation, and lifecycle management.
• Hands-on experience with CDMOs, commercial manufacturing environments, technical writing, and cross-functional leadership.

Nice to have

• Experience with modified-release or bioavailability-enhanced formulations.
• Experience supporting commercial product launches.
• Experience in partially or fully outsourced development models.

Culture & Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Basic life, accidental death and dismemberment, short- and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Accountability, strategic problem solving, patient and customer centricity, respectful collaboration, and professional development are emphasized.