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 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.
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
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.
CDMO & External Partner Strategy
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.
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
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.
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.
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.
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 [email protected].
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Skills Required
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline
- Alternatively, an M.S. degree with extensive, directly relevant industry experience
- 12–15+ years of pharmaceutical or biotech industry experience in small-molecule analytical development
- Leadership experience taking programs from early development through NDA filing and approval
- 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, GC, and dissolution
- Expertise in impurity control, including ICH Q3A/B, Q3C, and genotoxic impurities
- Expertise in solid-state characterization and stability using XRPD, DSC, and TGA
- Strong command of ICH Q1, Q2, and Q6A and FDA NDA expectations
- Ability to develop analytically robust, inspection-ready control strategies
- Strong risk-based decision-making, matrix leadership, regulatory writing, presentation, and communication skills
Otsuka America Pharmaceutical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Otsuka America Pharmaceutical and has not been reviewed or approved by Otsuka America Pharmaceutical.
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Healthcare Strength — Health coverage spans medical, dental, vision, prescription services, telehealth, life insurance, and disability, with notable mental‑health access through therapy, coaching, and digital tools. Wellness resources such as fitness reimbursement, nutrition support, and caregiver assistance further reinforce overall healthcare robustness.
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Retirement Support — Retirement offerings include a strong 401(k) match alongside personalized financial counseling for tax planning, education funding, home buying, and estate planning. These features position retirement support as a differentiator within the total rewards package.
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Leave & Time Off Breadth — Time‑off policies include flexible time off, paid holidays, volunteer time off, and a company winter holiday break. The breadth of leave programs supports work–life balance across various needs.
Otsuka America Pharmaceutical Insights
What We Do
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.








