Remote Associate Director, Drug Product & Process Dev

Otsuka America Pharmaceutical Inc.; Baton Rouge (LA); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Flexible time off

Paid holidays

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a senior role to lead late-stage drug product development, from Phase 3 through commercial launch, ensuring robust strategies and regulatory alignment.

You will oversee manufacturing processes, scale-up, and tech transfer while collaborating across regulatory, quality, and supply chain teams. The position requires strong experience with NDA/CMC submissions and global regulatory requirements, plus a focus on QbD and lifecycle management to support

Qualifications

• Late-stage drug product development (Phase 3 to commercial).
• NDA/CMC submissions and regulatory agency interactions.
• Drug product manufacturing, scale-up and tech transfer.
• CMC regulatory requirements and global frameworks.
• LCM strategies and post-approval changes.
• Excellent technical writing and cross-functional collaboration.

Responsibilities

• Lead late-stage drug product development activities (Phase 2/3 through commercial launch).
• Oversee drug product manufacturing processes, scale-up, tech transfer, PPQ, and commercial support.
• Align development strategies with Quality by Design (QbD) principles, including CMAs, CPPs, and control strategies.
• Author and review development plans, process descriptions, reports, and validation summaries.

Skills

Late-stage development

NDA CMC submissions

Drug product manufacturing

CMC regulatory knowledge

LCM strategies

Cross-functional collaboration

Technical writing

Education

PhD in Pharmaceutics/related (5+ yrs)

MS with 8+ years / BS with 10+ years

Job description

Otsuka America Pharmaceutical, Inc. is seeking a senior role to lead late-stage drug product development, from Phase 3 through commercial launch, ensuring robust strategies and regulatory alignment.

You will oversee manufacturing processes, scale-up, and tech transfer while collaborating across regulatory, quality, and supply chain teams. The position requires strong experience with NDA/CMC submissions and global regulatory requirements, plus a focus on QbD and lifecycle management to support