Associate Director, Analytical Development (Small Molecules)

Otsuka Pharmaceutical Companies (U.S.); Princeton (NJ); On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid time off & holidays

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Companies (U.S.) seeks an Associate Director of Analytical Development (Small Molecules) to lead strategy, execution, and portfolio analytics from early development through NDA submission and commercialization. You will own analytical control strategies, manage regulatory interactions, and build scalable capabilities across programs.

The role requires 12–15+ years in pharma/biotech analytical development, with deep expertise in stability, impurities, and regulatory

Qualifications

• Ph.D. or M.S. with extensive industry experience in small‑molecule analytics.
• 12–15+ years in pharma/biotech analytical development; NDA experience preferred.
• Proven leadership of analytical programs from early development through NDA/approval.

Responsibilities

• Lead analytical strategy and governance for small molecule programs from early development to commercialization.
• Own NDA analytical narrative and regulatory interactions with FDA and Health Authorities.
• Manage analytical risk, method lifecycle, validation timing, and comparability strategies.
• Define governance models for CDMOs/CROs and vendor oversight in collaboration with Quality and Procurement.
• Mentor and develop Senior Managers, build scalable analytical capabilities.

Skills

Analytical leadership

Regulatory liaison

Risk management

Cross-functional leadership

Strategic thinking

Education

Ph.D. in Analytical Chemistry or Pharmaceutical Sciences

M.S. in related field

Tools

HPLC/UPLC

GC

XRPD

DSC

TGA

ICH guidelines

Job description

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 agreed 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.

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.

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 [e-mail].

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.