Associate Director, Analytical Development (Small Molecules)

Position Summary

The Associate Director, Analytical Development (Small Molecules)will leadthestrategy, executionand portfoliolevelof analytical development activities supporting smallmolecule programs from early development through NDA submission, approval, and commercialization . This role is accountable for defining and defending analytical control strategies , ensuring regulatory success, and managing analytical risk across multiple programs.

Associate Director owns analytical strategy, risk posture, and NDA analytical positioning , serves as the primary analytical interface with Regulatory Affairs and Health Authorities, and builds scalable analytical capability across the organization.

Key Responsibilities

PortfolioLevel Analytical Strategy & Governance

• Contribute and execute analytical strategies for a portfolio of smallmolecule programs spanning early development through NDA and commercialization .
• Establish consistent,riskbasedapproaches for:
• Methodlifecycle evolution
• Specification setting and tightening
• Stability strategy andshelf life‑justification
• Providesanalyticalrecommendations and executesagreestrategies, with accountability for regulatory outcomes.

NDA Ownership & Regulatory Leadership

• Own the analytical narrative and positioning for NDAs, ensuring coherence across:
• Drug substance (3.2.S)
• Drug product (3.2.P)
• Impurities, stability, and control strategies
• Review, approve, and integrate analytical content authored by Senior Managers and external partners.
• Support and participate in analytical interactions with FDA and global Health Authorities, including:
• NDA review discussions
• Type C andpre‑NDAmeetings
• Analytical IR strategy and response alignment
• Provideanalytical SMEsupportduring pre ‑approvalinspections (PAIs) .

Analytical Risk Management & Lifecycle Planning

• Supportrisk‑basedassessments and provide technical inputregarding:
• Bridging vs.re‑developmentof analytical methods
• Timing and extent of method validation
• Specification flexibility pre‑vspost‑approval
• Own analytical comparability andpost‑approvalchange strategies.
• Ensure analytical approaches supportlong‑termcommercial robustness and global regulatory compliance.

CDMO & External Partner Strategy

• Support withdefiningand implementing analytical governance models for CDMOs and CROs.
• Set expectations forNDA‑defensibleanalytical work and inspection readiness.
• Lead escalation and resolution ofhigh‑impactanalytical issues with external partners.
• Support vendor selection, capability assessments, andlong‑termoutsourcing strategy in partnership with Quality and Procurement.

Cross ‑ Functional& CMC Leadership

• Act as a strategic thought partnertoRegulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain.
• Influence CMC development strategy and timelines through analytical risk assessment and mitigation planning.
• Represent Analytical Development in CMC governance forums and leadership discussions.

People Leadership & Capability Building

• Mentor Senior Managers and Managers ; coach leaders rather than individual contributors.
• Build and scale analytical capabilities aligned withlate‑stageand commercial needs.
• Own analytical resourcing strategy, succession planning, and capability development.

Qualifications

Education

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline; or
• M.S. with extensive, directly relevant industry experience.

Experience

• 12–15+years of pharmaceutical or biotech industry experience in small ‑ moleculeanalytical development .
• Demonstrated leadership of programs from early development through NDA filing and approval .
• Demonstratedexperience contributingtoof NDA analytical strategy and Health Authority engagement .
• Experience leading analytical functions in outsourced/CDMO ‑ baseddevelopment models .

Technical & Regulatory Expertise

• Deepexpertisein:
• Stabilityindicatingmethods (HPLC/UPLC, GC, dissolution)
• Impurity control (ICH Q3A/B, Q3C, genotoxic impurities)
• Solidstate characterization and stability (XRPD, DSC, TGA)
• Strong command of ICH Q1, Q2,Q6A and FDA expectations for NDAs.
• Demonstrated ability to develop analytically robust,inspectionreadycontrol strategies.

Leadership Competencies

• Strategic thinker with strongriskbaseddecisionmaking capability.
• Influential leader in matrixed organizations.
• Clear, authoritative communicator with strong regulatory writing and presentation skills.
• Proven ability to balance speed, risk, cost, and compliance.

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 $169,222.00 - Maximum $253,000.00, 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.

Application Deadline

This will be posted for a minimum of 5 business days.

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.

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Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

Otsuka is an equal opportunity employer. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting