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Analytical Development Small Molecule Jobs (NOW HIRING)

$134K - $201K/yr

Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry * Hands on experience in method development, characterization, and analytical ...

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Analytical Development Small Molecule information

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How much do analytical development small molecule jobs pay per year?

As of Sep 9, 2026, the average yearly pay for analytical development small molecule in the United States is $53,418.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,500.00 and $60,000.00 per year, depending on experience, location, and employer.

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Infographic showing various Analytical Development Small Molecule job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 82% Full Time, 14% Part Time, and 2% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $53,418 per year, or $25.7 per hour.

Associate Director, Analytical Development (Small Molecules)

Princeton, NJ

Otsuka
Pharmaceutical and Medicine Manufacturing • 1 - 5K employees

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 8 days ago


Job description

Position Summary

The Associate Director, Analytical Development (Small Molecules)will leadthestrategy, executionand portfoliolevelof analytical development activities supportingsmallmolecule programs from early development through NDA submission, approval, and commercialization. This role is accountable for defining and defendinganalytical control strategies, ensuring regulatory success, and managing analytical risk across multiple programs.

Associate Directorowns 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

PortfolioLevel Analytical Strategy & Governance

  • Contribute and executeanalytical strategiesfor a portfolio of smallmolecule programs spanningearly development through NDA and commercialization.

  • Establish consistent,riskbasedapproaches for:

  • Methodlifecycle evolution

  • Specification setting and tightening

  • Stability strategy andshelf lifejustification

  • Providesanalyticalrecommendations and executesagreestrategies, with accountability for regulatory outcomes.

NDA Ownership & Regulatory Leadership

  • Own theanalytical narrative and positioningfor 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 andparticipateinanalytical interactions with FDA and global Health Authorities, including:

  • NDA review discussions

  • Type C andpreNDAmeetings

  • Analytical IR strategy and response alignment

  • Provideanalytical SMEsupportduringpreapprovalinspections (PAIs).

Analytical Risk Management & Lifecycle Planning

  • Supportriskbasedassessments and provide technical inputregarding:

  • Bridging vs.redevelopmentof analytical methods

  • Timing and extent of method validation

  • Specification flexibility prevspostapproval

  • Own analytical comparability andpostapprovalchange strategies.

  • Ensure analytical approaches supportlongtermcommercial robustness and global regulatory compliance.

CDMO & External Partner Strategy

  • Support withdefiningand implementinganalytical governance modelsfor CDMOs and CROs.

  • Set expectations forNDAdefensibleanalytical work and inspection readiness.

  • Lead escalation and resolution ofhighimpactanalytical issues with external partners.

  • Support vendor selection, capability assessments, andlongtermoutsourcing strategy in partnership with Quality and Procurement.

CrossFunctional& CMC Leadership

  • Act as a strategic thought partnertoRegulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain.

  • InfluenceCMC development strategy and timelinesthrough analytical risk assessment and mitigation planning.

  • Represent Analytical Development in CMC governance forums and leadership discussions.

People Leadership & Capability Building

  • MentorSenior Managers and Managers; coach leaders rather than individual contributors.

  • Build and scale analytical capabilities aligned withlatestageand 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+yearsof pharmaceutical or biotech industry experience insmallmoleculeanalytical development.

  • Demonstrated leadership of programs fromearly development through NDA filing and approval.

  • Demonstratedexperience contributingtoofNDA analytical strategy and Health Authority engagement.

  • Experience leading analytical functions inoutsourced/CDMObaseddevelopment models.

Technical & Regulatory Expertise

  • Deepexpertisein:

  • Stabilityindicatingmethods (HPLC/UPLC, GC, dissolution)

  • Impurity control (ICH Q3A/B, Q3C, genotoxic impurities)

  • Solidstate characterization and stability (XRPD, DSC, TGA)

  • Strong command ofICH Q1, Q2,Q6Aand FDA expectations for NDAs.

  • Demonstrated ability to develop analytically robust,inspectionreadycontrol strategies.

Leadership Competencies

  • Strategic thinker with strongriskbaseddecisionmaking 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.

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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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.

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