Senior Director, Small Molecule API Development

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 231,000 - 345,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a Senior Director, Small Molecule Drug Substance Development to lead strategy, development, and manufacturing of small molecule APIs from candidate nomination to commercial readiness.

You will guide route selection, process chemistry, optimization, impurity control, scale-up, and regulatory strategy while managing CDMOs and cross-functional teams in a fully virtual setting.

Qualifications

• 15+ years of progressive experience in pharmaceutical or biotechnology drug substance development.
• Demonstrated 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.

Responsibilities

• Develop and execute phase-appropriate drug substance development strategies from candidate nomination through commercial readiness.
• Develop and execute API development plans aligned with program, portfolio, and corporate objectives.
• Provide scientific and technical leadership in route selection, process chemistry, process optimization, impurity control, scale-up, and manufacturing strategy.
• Drive development of safe, robust, scalable, and commercially sustainable manufacturing processes.
• Establish development strategies that support clinical supply, regulatory submissions, process validation, and commercial launch readiness.
• Identify and elevate technical and operational risks and implement mitigation strategies to support program timelines and organizational objectives.
• Provide scientific oversight for process characterization activities and development of process control strategies.
• Lead technical evaluations of novel technologies and manufacturing approaches that improve process robustness, productivity, safety, and cost efficiency.
• Provide strategic oversight and technical guidance for technology transfer, scale-up, and manufacturing activities performed by CDMOs.
• Contribute scientific and technical expertise to due diligence, business development assessments, and portfolio evaluations.

Skills

Leadership

Strategy development

Process chemistry

Regulatory collaboration

Budget management

CDMO management

Education

PhD in Organic Chemistry or related field

MS in Chemistry/Engineering considered

Tools

CDMO management tools

Process analytics

Job description

Otsuka Pharmaceutical Co., Ltd. seeks a Senior Director, Small Molecule Drug Substance Development to lead strategy, development, and manufacturing of small molecule APIs from candidate nomination to commercial readiness.

You will guide route selection, process chemistry, optimization, impurity control, scale-up, and regulatory strategy while managing CDMOs and cross-functional teams in a fully virtual setting.