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Associate Director, Analytical Development (Small Molecules)

L7

otsuka pharmaceuticalPrinceton, NJyesterday

$169,222 - $253,000 per year

Occupations

Natural Sciences ManagersRegulatory Affairs ManagersQuality Control Systems Managers

Industries

Research and Development in BiotechnologyPharmaceutical Preparation ManufacturingResearch and Development in the Physical, Engineering, and Life Sciences
Associate Director, Analytical Development (Small Molecules) 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 & GovernanceNDA Ownership & Regulatory Leadership
  • Analytical Risk Management & Lifecycle PlanningCDMO & External Partner Strategy
  • Cross-Functional & CMC Leadership
  • People Leadership & Capability Building
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
  • Strategic Thinking & Problem Solving
  • Patient & Customer Centricity
  • Impactful Communication
  • Respectful Collaboration
  • Empowered Development
Compensation: 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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Level

ManagerL7

Salary

$169,222 - $253,000 per year

Location

Princeton, NJ

Occupation

Natural Sciences Managers

Industry

Research and Development in Biotechnology

Posted

yesterday

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