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Associate Director, Drug Product & Process Development – Small Molecules
Otsuka Pharmaceutical Companies (U.S.). Provide technical and strategic leadership for late-stage drug product development programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in late-stage drug product development, including formulation optimization, process validation, and regulatory submissions. Proven ability to lead cross-functional teams and mentor junior staff while ensuring compliance with CMC regulatory requirements.
Highest-signal resume keywords
PhD In PharmaceuticsLate-Stage Drug Product DevelopmentNDA CMC SubmissionsTechnical WritingRegulatory Agency Interactions
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Formulation OptimizationProcess ValidationTech TransferManufacturing ProcessesLifecycle ManagementChange Impact AssessmentContinuous ImprovementAseptic ManufacturingSolid Oral Dosage FormsCommercial Manufacturing Support
Soft Skills
Technical LeadershipCommunicationCross-Functional CollaborationMentoringPeople Leadership
Industry Keywords
Quality By DesignCMC Regulatory RequirementsFDAEMAHealth Authority InteractionsProcess ImprovementsSpecification UpdatesPost-Approval ChangesCDMOsGlobal Regulatory Frameworks
About the role
Key responsibilities & impact- Provide technical and strategic leadership for late-stage drug product development programs
- Lead Phase 2/3 through commercial-launch activities, including formulation optimization, process validation readiness, and robustness studies
- Provide technical oversight for manufacturing processes, scale-up, tech transfer, PPQ, and commercial manufacturing support
- Ensure development strategies align with Quality by Design principles and defined CMAs, CPPs, and control strategies
- Author and review technical development plans, process descriptions, development reports, and validation summaries
- Serve as CMC drug product lead for NDA and/or MAA filings, including Modules 2.3 and 3
- Support FDA, EMA, and other Health Authority interactions, including information requests, deficiency responses, and commitment fulfillment
- Lead and support post-approval lifecycle management activities, including formulation changes, site transfers, process improvements, specification updates, and alternate sourcing
- Assess change impact and support regulatory submissions such as PAS, CBE-30, annual reports, and variations
- Drive continuous improvement to enhance process robustness, manufacturability, and supply reliability
- Represent drug product technical development on cross-functional program teams
- Provide technical direction to CMOs/CDMOs
- Mentor junior scientists and engineers and contribute to organizational CMC capabilities
Requirements
What you’ll need- 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
- Demonstrated experience in late-stage drug product development from Phase 3 to commercial
- Direct involvement in NDA or equivalent CMC submissions, including authorship and regulatory agency interactions
- Expertise in drug product manufacturing processes, scale-up, tech transfer, and validation
- Strong understanding of CMC regulatory requirements and global regulatory frameworks
- Hands-on experience with lifecycle management strategies and post-approval changes
- Excellent technical writing, communication, and cross-functional collaboration skills
- Experience with external manufacturing partners (CDMOs) preferred
- Experience with aseptic, solid oral, or other relevant dosage forms preferred
- Familiarity with commercial manufacturing and supply support preferred
- Prior people leadership or matrix leadership experience preferred
Benefits
Comp & perks- Comprehensive medical, dental, vision, and prescription drug coverage
- Company-provided basic life insurance
- Accidental death and dismemberment insurance
- Short-term and long-term disability insurance
- Tuition reimbursement
- Student loan assistance
- Generous 401(k) match
- Flexible time off
- Paid holidays
- Paid leave programs
- Other company-provided benefits
- Incentive opportunity