Remote Lead Drug Product & Process Development

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

Benefits offered by this job

Medical benefits

Dental coverage

Vision coverage

401(k) match

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a senior expert to lead late-stage drug product development from Phase 2/3 through commercial launch. Responsibilities include formulation optimization, process validation readiness, and robust control strategies.

The role provides technical oversight of manufacturing processes, supports NDA/CMC submissions, and drives cross-functional collaboration across Regulatory, Quality, Manufacturing, and Supply Chain in a remote, full-time capacity.

Qualifications

• Demonstrated experience in late-stage drug product development (Phase 3 to commercial).
• Direct involvement in NDA/CMC submissions and regulatory interactions.
• Hands-on expertise with drug product manufacturing, scale-up, tech transfer, and validation.

Responsibilities

• Lead late-stage drug product development activities through launch with formulation optimization and process validation readiness.
• Provide technical oversight for drug product manufacturing processes including scale-up and tech transfer.
• Ensure development strategies align with QbD and clearly defined CMAs, CPPs, and control strategies.
• Author and review development plans, process descriptions, and validation summaries.

Skills

late-stage development

NDA/CMC submissions

tech transfer

cross-functional leadership

technical writing

Education

PhD in Pharmaceutics/related (5+ yrs)

MS with 8+ yrs / BS with 10+ yrs

Job description

Otsuka America Pharmaceutical, Inc. is seeking a senior expert to lead late-stage drug product development from Phase 2/3 through commercial launch. Responsibilities include formulation optimization, process validation readiness, and robust control strategies.

The role provides technical oversight of manufacturing processes, supports NDA/CMC submissions, and drives cross-functional collaboration across Regulatory, Quality, Manufacturing, and Supply Chain in a remote, full-time capacity.