Remote Senior Drug Product & Process Development Lead

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

401(k) match

Job summary

Otsuka America Pharmaceutical Inc. is seeking a senior leader for Drug Product & Process Development to drive late-stage development through commercial launch.

You will oversee formulation optimization, process validation readiness, and robustness studies, ensuring alignment with QbD and regulatory expectations. You will lead NDA/CMC submissions, manage interactions with FDA/EMA, and direct post-approval lifecycle activities including changes and site transfers.

Qualifications

• PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related discipline with 5+ years of industry experience OR
• MS with 8+ years / BS with 10+ years of progressive experience in drug product/process development
• Late-stage drug product development (Phase 3 to commercial)
• Direct involvement in NDA/CMC submissions and regulatory interactions
• Experience with drug product manufacturing processes, scale-up, tech transfer and validation
• Strong understanding of CMC regulatory requirements and global frameworks
• Hands-on experience with LCM strategies and post-approval changes

Responsibilities

• Lead late-stage drug product development activities (Phase 2/3 through launch) including formulation optimization and validation readiness.
• Provide technical oversight for drug product manufacturing processes, including scale-up, tech transfer, PPQ, and commercial support.
• Align development strategies with Quality by Design (QbD) principles and define CMAs, CPPs, and control strategies.
• Author and review development plans, process descriptions, development reports, and validation summaries.
• Act as CMC drug product lead for NDA filings and NDA/MAA regulatory submissions.
• Support health authority interactions (FDA, EMA) with information requests and deficiency responses.
• Ensure content complies with current regulatory expectations and ICH Q8–Q12 guidelines.
• Lead post-approval LCM activities: formulation changes, site transfers, and change management.
• Assess change impact and support regulatory submissions (PAS, CBE-30, annual reports, variations).
• Drive continuous improvement for robustness, manufacturability, and supply reliability.
• Provide technical direction to CMOs/CDMOs and mentor junior scientists.

Skills

Late-stage DP development

NDA CMC submissions

Scale-up tech transfer

Regulatory knowledge

Education

PhD in Pharmaceutics/Engineering/Pharmaceutical Sciences

MS 8+ yrs / BS 10+ yrs in DP/Process Development

Job description

Otsuka America Pharmaceutical Inc. is seeking a senior leader for Drug Product & Process Development to drive late-stage development through commercial launch.

You will oversee formulation optimization, process validation readiness, and robustness studies, ensuring alignment with QbD and regulatory expectations. You will lead NDA/CMC submissions, manage interactions with FDA/EMA, and direct post-approval lifecycle activities including changes and site transfers.