Associate Director, Analytical Development (Small Molecules)

Otsuka Pharmaceutical Co., Ltd. • Princeton, NJ

1d • $169,222 - $253,000 • Onsite

About The Position

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.

Requirements

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

Responsibilities

• Contribute and execute analytical strategies 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 strategies, with accountability for regulatory outcomes.
• 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).
• Support 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.
• Support with defining and implementing 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.
• 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.
• Mentor 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.

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
• paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree