CMC Drug Product & Process Development Lead

Otsuka; United States; Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical,Dental,Vision

401(k) match

Paid time off

Job summary

Otsuka is seeking an Associate Director of Drug Product & Process Development to lead early and late‑stage formulation development and process characterization, ensuring scalable, regulatory‑compliant drug product strategies across Phase 1/2 to Phase 3 and beyond.

You will drive QbD‑based development, oversee scale‑up and tech transfer, and coordinate with external CDMOs while supporting regulatory filings and health authority interactions.

Qualifications

• PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related discipline with 5+ years of relevant industry experience OR MS with 8+ years / BS with 10+ years of progressive experience in drug product/process development.

Responsibilities

• Lead early/late‑stage drug product development activities (Phase 1/2 through Phase 3) for oral, injectable and/or complex dosage forms.
• Provide technical oversight for drug product manufacturing processes, including scale‑up, technical transfer, and manufacturing support.
• Ensure development strategies align with QbD principles and define CMAs, CPPs, and control strategies.
• Author and review development plans, process descriptions, development reports, and validation summaries.
• Serve as CMC/Drug Product Lead for regulatory filings and support Health Authority interactions.

Skills

Drug product development

CMC submissions

Regulatory interactions

Scale-up & tech transfer

Education

PhD in Pharmaceutics

MS/BS with 8+ years in industry

Job description

Otsuka is seeking an Associate Director of Drug Product & Process Development to lead early and late‑stage formulation development and process characterization, ensuring scalable, regulatory‑compliant drug product strategies across Phase 1/2 to Phase 3 and beyond.

You will drive QbD‑based development, oversee scale‑up and tech transfer, and coordinate with external CDMOs while supporting regulatory filings and health authority interactions.