Senior Director, Analytical Development and Quality Control – Small Molecules

🕒 June 29

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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

• Provides strategic and operational leadership for all analytical activities supporting drug substance and drug product development • Ensures regulatory compliance and leads internal teams and external partners to deliver high quality analytical data across all development stages • Defines and executes the analytical development and QC strategy across early development, late-stage clinical, and commercial lifecycle • Leads development, qualification, validation, and transfer of analytical methods • Provides oversight of internal and external QC testing labs supporting clinical and commercial programs • Acts as analytical lead during health authority inspections, audits, and agency interactions • Establishes performance metrics, governance models, and continuous improvement plans with partners • Builds, mentors, and develops high-performing analytical and QC teams • Partners closely with Process Development, Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and Program Management

🎯 Requirements

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline • 15+ years of experience in analytical development and/or QC within the biopharmaceutical or pharmaceutical industry • 7+ years in people leadership roles with experience building and scaling teams • Direct experience supporting late-stage development and commercial products • Strong track record of regulatory interactions and successful submissions • Provide scientific and operational leadership across all phases of drug development—from early phase through commercial launch. • Lead method development, qualification, validation, and transfer for drug substances and drug products (small molecules, peptides, biologics) • Oversee characterization studies, impurity profiling, and forced degradation assessments • Ensure robust analytical control strategies are in place to support product lifecycle management • Manage QC testing for raw materials, intermediates, drug substances, and drug products across internal and external labs. • Ensure timely and compliant release testing, stability program execution, and reference standard qualification • Author and review analytical sections of regulatory submissions (INDs, NDAs, BLAs, MAAs) • Support responses to regulatory queries and inspections with scientific rigor and clarity. • Build, lead, and mentor a high-performing team of analytical scientists and QC professionals • Support career development and succession planning within the department. • Select, qualify, and manage CROs, CMOs, and CTLs for outsourced analytical and QC activities • Ensure external partners meet performance, quality, and compliance expectations • Negotiate contracts and monitor budgets for outsourced services

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • 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