Senior Director, Small Molecule Drug Substance Development

Otsuka Pharmaceutical Companies (U.S.)

. Provide strategic, scientific, and operational leadership for small molecule API development from candidate nomination through commercial readiness .

Posted 9/21/2026full-timeRemote • United StatesSenior💰 $230,720 - $345,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in small molecule API development, including process chemistry, technology transfer, and commercialization. Proven leadership in managing scientific teams and driving strategic drug substance development from candidate nomination to commercial readiness.

Highest-signal resume keywords

PhD In Organic Chemistry15+ Years In Pharmaceutical DevelopmentLeadership In Small Molecule Process ChemistryExperience With CDMO ManagementStrong Project Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process ChemistryAPI DevelopmentTechnology TransferProcess OptimizationScale-UpProcess CharacterizationProcess ValidationImpurity Control StrategiesSynthetic Organic ChemistryCommercial Manufacturing

Soft Skills

Strategic ThinkingStrong Scientific JudgmentExcellent Verbal CommunicationInterpersonal SkillsAbility To Influence Stakeholders

Industry Keywords

Drug Substance DevelopmentRegulatory SubmissionsGlobal Drug Substance CMC RequirementsPharmaceutical Development PrinciplesContemporary Manufacturing Technologies

About the role

Key responsibilities & impact

Provide strategic, scientific, and operational leadership for small molecule API development from candidate nomination through commercial readiness
Establish and execute drug substance development strategies and API development plans
Lead route selection, process chemistry, process optimization, impurity control, scale-up, and manufacturing strategy
Drive safe, robust, scalable, and commercially sustainable manufacturing processes
Support clinical supply, regulatory submissions, process validation, and commercial launch readiness
Identify technical and operational risks and implement mitigation strategies
Oversee process characterization and process control strategy development
Evaluate novel technologies and manufacturing approaches
Provide oversight and guidance for CDMO technology transfer, scale-up, and manufacturing activities
Contribute to due diligence, business development assessments, portfolio evaluations, departmental planning, performance metrics, and resource strategies
Manage departmental budgets, external development expenditures, and consulting resources
Author, review, and approve drug substance sections of INDs, IMPDs, CTAs, NDAs, MAAs, and related global filings
Provide input into regulatory strategies and health authority interactions
Present and defend development approaches during inspections, audits, and agency meetings
Partner with drug product development, analytical sciences, quality assurance, regulatory affairs, supply chain, and other stakeholders
Lead, mentor, and develop process chemists, scientists, and drug substance development professionals
Build technical capabilities and foster scientific rigor, innovation, accountability, collaboration, and continuous improvement

Requirements

What you’ll need

PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline preferred
Master's degree with significant relevant industry experience may be considered
15+ years of progressive experience in pharmaceutical or biotechnology drug substance development
Leadership experience in small molecule process chemistry and API development
Minimum of 5 years of experience leading scientific teams and managing people
Proven success advancing multiple small molecule programs from candidate nomination through late-stage clinical development and commercial readiness
Significant experience leading process chemistry, technology transfer, scale-up, and API commercialization activities
Extensive experience managing CDMOs and external development partners
Demonstrated ability to lead cross-functional programs within a matrixed organization
Experience managing departmental budgets and resource planning
Deep expertise in synthetic organic chemistry and pharmaceutical process development
Strong understanding of route selection, process optimization, scale-up, technology transfer, process characterization, process validation, and commercial manufacturing
Comprehensive knowledge of global drug substance CMC requirements and applicable regulatory guidelines
Experience with impurity control strategies, genotoxic impurity management, and process control strategies
Strong understanding of pharmaceutical development principles from early development through commercialization
Familiarity with contemporary manufacturing technologies and external manufacturing business models
Strategic thinking, strong scientific judgment, and business acumen
Ability to build, inspire, and lead high-performing technical organizations
Strong project management and prioritization capabilities
Ability to influence stakeholders and drive decision-making across complex organizations
Excellent verbal, written, and presentation skills
Strong interpersonal skills and ability to develop productive internal and external relationships
Ability to operate effectively in a fast-paced and evolving development environment

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