Position SummaryĀ
The Associate Director, Analytical Development (Small Molecules)Ā will leadĀ theĀ strategy, executionĀ and portfolioĀ levelĀ of analytical development activities supportingĀ smallĀ molecule programs from early development through NDA submission, approval, and commercialization. This role is accountable for defining and defendingĀ analytical control strategies, ensuring regulatory success, and managing analytical risk across multiple programs.Ā
Associate DirectorĀ 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.Ā
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Key ResponsibilitiesĀ
PortfolioĀ Level Analytical Strategy & GovernanceĀ
Contribute and executeĀ analytical strategiesĀ for a portfolio of smallĀ molecule programs spanningĀ early development through NDA and commercialization.Ā
Establish consistent,Ā riskĀ basedĀ approaches for:Ā Ā
MethodĀ lifecycle evolutionĀ
Specification setting and tighteningĀ
Stability strategy andĀ shelf lifeāĀ justificationĀ
ProvidesĀ analyticalĀ recommendations and executesĀ agreeĀ strategies, with accountability for regulatory outcomes.Ā
NDA Ownership & Regulatory LeadershipĀ
Own theĀ analytical narrative and positioningĀ for NDAs, ensuring coherence across:Ā Ā
Drug substance (3.2.S)Ā
Drug product (3.2.P)Ā
Impurities, stability, and control strategiesĀ
Review, approve, and integrate analytical content authored by Senior Managers and external partners.Ā
Support andĀ participateĀ inĀ analytical interactions with FDA and global Health Authorities, including:Ā Ā
NDA review discussionsĀ
Type C andĀ preāNDAĀ meetingsĀ
Analytical IR strategy and response alignmentĀ
ProvideĀ analytical SMEĀ supportĀ duringĀ preāapprovalĀ inspections (PAIs).Ā
Analytical Risk Management & Lifecycle PlanningĀ
SupportĀ riskābasedĀ assessments and provide technical inputĀ regarding:Ā Ā
Bridging vs.Ā reādevelopmentĀ of analytical methodsĀ
Timing and extent of method validationĀ
Specification flexibility preāĀ vsĀ postāapprovalĀ
Own analytical comparability andĀ postāapprovalĀ change strategies.Ā
Ensure analytical approaches supportĀ longātermĀ commercial robustness and global regulatory compliance.Ā
CDMO & External Partner StrategyĀ
Support withĀ definingĀ and implementingĀ analytical governance modelsĀ for CDMOs and CROs.Ā
Set expectations forĀ NDAādefensibleĀ analytical work and inspection readiness.Ā
Lead escalation and resolution ofĀ highāimpactĀ analytical issues with external partners.Ā
Support vendor selection, capability assessments, andĀ longātermĀ outsourcing strategy in partnership with Quality and Procurement.Ā
CrossāFunctionalĀ & CMC LeadershipĀ
Act as a strategic thought partnerĀ toĀ Regulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain.Ā
InfluenceĀ CMC development strategy and timelinesĀ through analytical risk assessment and mitigation planning.Ā
Represent Analytical Development in CMC governance forums and leadership discussions.Ā
People Leadership & Capability BuildingĀ
MentorĀ Senior Managers and Managers; coach leaders rather than individual contributors.Ā
Build and scale analytical capabilities aligned withĀ lateāstageĀ and commercial needs.Ā
Own analytical resourcing strategy, succession planning, and capability development.Ā
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QualificationsĀ
EducationĀ
Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline;Ā orĀ
M.S. with extensive, directly relevant industry experience.Ā
ExperienceĀ
12ā15+Ā yearsĀ of pharmaceutical or biotech industry experience inĀ smallāmoleculeĀ analytical development.Ā
Demonstrated leadership of programs fromĀ early development through NDA filing and approval.Ā
DemonstratedĀ experience contributingĀ toĀ ofĀ NDA analytical strategy and Health Authority engagement.Ā
Experience leading analytical functions inĀ outsourced/CDMOābasedĀ development models.Ā
Technical & Regulatory ExpertiseĀ
DeepĀ expertiseĀ in:Ā Ā
StabilityĀ indicatingĀ methods (HPLC/UPLC, GC, dissolution)Ā
Impurity control (ICH Q3A/B, Q3C, genotoxic impurities)Ā
SolidĀ state characterization and stability (XRPD, DSC, TGA)Ā
Strong command ofĀ ICH Q1, Q2,Ā Q6AĀ and FDA expectations for NDAs.Ā
Demonstrated ability to develop analytically robust,Ā inspectionĀ readyĀ control strategies.Ā
Leadership CompetenciesĀ
Strategic thinker with strongĀ riskĀ basedĀ decisionĀ making capability.Ā
Influential leader in matrixed organizations.Ā
Clear, authoritative communicator with strong regulatory writing and presentation skills.Ā
Proven ability to balance speed, risk, cost, and compliance.Ā
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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 -Ā Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value othersā 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: Ā 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:Ā
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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.Ā
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Otsuka is an equal opportunity employer.Ā 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. Ā Ā
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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.Ā You can request reasonable accommodations by contacting EEAccommodations@otsuka-us.com.Ā
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