Remote Senior Director, Small Molecule API Development

Otsuka America Pharmaceutical Inc.; Juneau (AK); Remote; USD 231,000 - 345,000; Full time

Job summary

Otsuka America Pharmaceutical, Inc. seeks a Senior Director to lead drug substance development for small molecules, overseeing strategy, process chemistry, and Regulatory alignment.

The role coordinates with CDMOs, analytics, and cross-functional teams to drive programs from nomination to commercial readiness. The position requires 15+ years in drug substance development, proven leadership, and a track record of advancing multiple programs through late-stage development and launch readiness, in

Qualifications

• ,15+ years of progressive experience in pharmaceutical or biotechnology drug substance development.
• 14Demonstrated 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.
• Contribute to departmental planning, performance metrics, and resource strategies.
• Manage departmental budgets, external development expenditures, and consulting resources.

Skills

Strategic leadership

Team leadership

Regulatory strategy

Process chemistry

CDMO management

Cross-functional collaboration

Budget management

Education

PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related

Master's degree with significant industry experience

Job description

Otsuka America Pharmaceutical, Inc. seeks a Senior Director to lead drug substance development for small molecules, overseeing strategy, process chemistry, and Regulatory alignment.

The role coordinates with CDMOs, analytics, and cross-functional teams to drive programs from nomination to commercial readiness. The position requires 15+ years in drug substance development, proven leadership, and a track record of advancing multiple programs through late-stage development and launch readiness, in