Associate Director, Analytical Development (Small Molecules)

Position Summary

The Associate Director, Analytical Development (Small Molecules)   will lead   the   strategy, execution   and portfolio   level   of analytical development activities supporting   small   molecule 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

Portfolio   Level Analytical Strategy & Governance

Contribute and execute   analytical strateg ies   for a portfolio of small   molecule programs spanning   early development through NDA and commercialization .

Establish consistent,   risk   based   approaches for:

Method   lifecycle evolution

Specification setting and tightening

Stability strategy and   shelf life ‑   justification

Provides   analytical   recommendations and executes   agree   strateg ies , 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 and   pre ‑ NDA   meetings

Analytical IR strategy and response alignment

Provide   analytical SME   support   during   pre ‑ approval   inspections (PAIs) .

Analytical Risk Management & Lifecycle Planning

Suppor t   risk ‑ based   assessments and provide technical input   regarding:

Bridging vs .   re ‑ development   of analytical methods

Timing and extent of method validation

Specification flexibility pre ‑   vs   post ‑ approval

Own analytical comparability and   post ‑ approval   change strategies.

Ensure analytical approaches support   long ‑ term   commercial robustness and global regulatory compliance.

CDMO & External Partner Strategy

Support with   d efin ing   and implement ing   analytical governance models   for CDMOs and CROs.

Set expectations for   NDA ‑ defensible   analytical work and inspection readiness.

Lead escalation and resolution of   high ‑ impact   analytical issues with external partners.

Support vendor selection, capability assessments, and   long ‑ term   outsourcing strategy in partnership with Quality and Procurement.

Cross ‑ Functional   & CMC Leadership

Act as a strategic thought partner   to   Regulatory 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

M entor   Senior Managers and Managers ; coach leaders rather than individual contributors.

Build and scale analytical capabilities aligned with   late ‑ stage   and 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 ‑ molecule   analytical development .

Demonstrated leadership of programs from   early development through NDA filing and approval .

Demonstrated   experience contributing   to   of   NDA analytical strategy and Health Authority engagement .

Experience leading analytical functions in   outsourced/ CDMO ‑ based   development models .

Technical & Regulatory Expertise

Deep   expertise   in:

Stability   indicating   methods (HPLC/UPLC, GC, dissolution)

Impurity control (ICH Q3A/B, Q3C, genotoxic impurities)

Solid   state characterization and stability (XRPD, DSC, TGA)

Strong command of   ICH Q1, Q2,   Q6A   and FDA expectations for NDAs.

Demonstrated ability to develop analytically robust,   inspection   ready   control strategies.

Leadership Competencies

Strategic thinker with strong   risk   based   decision   making 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.

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