Senior Director, Small Molecule Drug Substance Development

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $230.7k - $345k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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

• 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

• 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