Senior Director, Analytical Development and Quality Control (Small Molecules)

The Senior Director, Analytical Development & Quality Control (Small Molecules) provides strategic and operational leadership for all analytical activities supporting drug substance and drug product development, clinical supply, commercial manufacturing, and lifecycle management. This leader is accountable for building and executing robust analytical strategies, ensuring regulatory compliance, and leading internal teams and external partners to deliver high quality analytical data across all development stages.The role serves as a key CMC partner to Process Development, Manufacturing, Quality, Regulatory Affairs, and external CDMOs, and plays a critical leadership role in regulatory filings, inspections, and post approval commitments.

Key Responsibilities

Strategic Leadership

• Define and execute the analytical development and QC strategy across early development, late‑stage clinical, and commercial lifecycle.
• Build scalable, phase‑appropriate analytical control strategies aligned with global regulatory expectations (FDA, EMA, ICH).
• Serve as the analytical subject matter expert on CMC core teams and governance forums.

Analytical Development

• Lead development, qualification, validation, and transfer of analytical methods for drug substance, drug product, in‑process, and stability testing.
• Ensure methods are robust, stability‑indicating, and fit for intended use across lifecycle stages.
• Drive adoption of new technologies (e.g., advanced characterization, automation, digital data integrity solutions) where appropriate.

Quality Control Operations

• Provide oversight of internal and external QC testing labs supporting clinical and commercial programs.
• Ensure compliance with cGMP, data integrity, and quality system requirements.
• Oversee investigations, OOS/OOT events, troubleshooting methods, and CAPA implementation.

Regulatory & Compliance

• Author, review, and approve analytical sections of INDs, NDAs/BLAs, MAAs, and global regulatory submissions.
• Act as analytical lead during health authority inspections, audits, and agency interactions.
• Support responses to regulatory questions, commitments, and post‑approval changes.

External Partnerships

• Lead analytical/QC oversight of CDMOs, CROs, and external testing laboratories.
• Establish performance metrics, governance models, and continuous improvement plans with partners.
• Ensure successful method transfer, validation, and ongoing compliance at external sites.

People & Organization Leadership

• Build, mentor, and develop high‑performing analytical and QC teams.
• Establish clear organizational structure, talent development plans, and succession planning.
• Foster a culture of scientific excellence, quality, and accountability.

Cross‑Functional Collaboration

• Partner closely with Process Development, Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and Program Management.
• Support technical due diligence, lifecycle management, and CMC innovation initiatives.

Required Qualifications

Education

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline
   

Experience

• 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.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $230,720.00 - Maximum $345,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company 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, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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