Remote Lead, Small Molecule Drug Product Development

Otsuka America Pharmaceutical Inc.; Tallahassee (FL); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical

Dental coverage

Vision care

401(k) match

Paid holidays

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a senior professional to lead late-stage drug product development toward Phase 3 and commercial launch. You will oversee formulation optimization, process validation readiness, and robust risk assessments.

Role requires NDA/CMC submission experience, cross-functional collaboration, and deep knowledge of drug product manufacturing processes, scale‑up, and transfer.

Qualifications

• Must have 5+ years in late-stage drug product development (Phase 3 to commercial).
• Direct involvement in NDA/CMC submissions and regulatory interactions.
• Strong understanding of drug product manufacturing processes, scale-up, tech transfer, and validation.

Responsibilities

• Lead late-stage drug product development activities from Phase 2/3 to launch.
• Provide technical oversight for drug product manufacturing processes including scale-up and tech transfer.
• Ensure development aligns with QbD principles and clear control strategies.
• Author and review development plans, reports, and validation summaries.

Skills

Late-stage development

Regulatory submissions

Cross-functional leadership

Technical writing

Quality by Design

Education

PhD in Pharmaceutics/related field

MS/BS with extensive experience

Job description

Otsuka America Pharmaceutical, Inc. is seeking a senior professional to lead late-stage drug product development toward Phase 3 and commercial launch. You will oversee formulation optimization, process validation readiness, and robust risk assessments.

Role requires NDA/CMC submission experience, cross-functional collaboration, and deep knowledge of drug product manufacturing processes, scale‑up, and transfer.