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Otsuka Pharmaceutical

Global pharma maker of Abilify

Associate Director - Analytical Development, Small Molecules

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timePrinceton, NJ, USAIn-person

About the Job

Requirements

  • A Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline, or an M.S. with extensive, directly relevant industry experience.
  • 12–15+ years of pharmaceutical or biotechnology industry experience in small-molecule analytical development.
  • Demonstrated leadership of programs from early development through NDA filing and approval.
  • Demonstrated experience contributing to NDA analytical strategy and Health Authority engagement.
  • Experience leading analytical functions in outsourced or CDMO-based development models.
  • Deep expertise in stability-indicating methods, including HPLC/UPLC, gas chromatography, and dissolution.
  • Expertise in impurity control, including ICH Q3A/B, Q3C, and genotoxic impurities.
  • Expertise in solid-state characterization and stability, including XRPD, DSC, and TGA.
  • Strong command of ICH Q1, Q2, Q6A, and FDA expectations for NDAs.
  • Ability to develop analytically robust, inspection-ready control strategies.
  • Strategic thinking and risk-based decision-making capability.
  • Ability to influence in matrixed organizations.
  • Regulatory writing and presentation skills.
  • Ability to balance speed, risk, cost, and compliance.

Responsibilities

  • Contribute to 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, and stability strategy and shelf-life justification.
  • Provide analytical recommendations and execute agreed 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 the FDA and global Health Authorities, including NDA review discussions, Type C and pre-NDA meetings, and analytical information-request strategy and response alignment.
  • Provide analytical subject-matter-expert support during pre-approval inspections.
  • Support risk-based assessments and provide technical input regarding bridging versus redevelopment of analytical methods, timing and extent of method validation, and specification flexibility before versus after approval.
  • Own analytical comparability and post-approval change strategies.
  • Ensure analytical approaches support long-term commercial robustness and global regulatory compliance.
  • Support 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, and 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.

About the Company

Otsuka Pharmaceutical

Global pharma maker of Abilify

Otsuka Pharmaceutical develops and markets medicines and health products worldwide, including prescription drugs and nutraceutical beverages. Its product lineup ranges from pharmaceutical treatments such as Abilify (an antipsychotic) to consumer health drinks like Pocari Sweat, which helps replenish electrolytes. Abilify works as a psychiatric medication used to treat conditions such as schizophrenia and bipolar disorder, while Pocari Sweat is an ion-replacement beverage designed to restore minerals and fluids after activity or heat. The company differentiates itself through a long history dating back to its founding in 1921, a broad, globally scaled portfolio spanning drugs and health beverages, and a focus on health improvements across populations. Its stated goal is to create new products for better health worldwide.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Tokyo, Japan
Founded
1921

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