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Associate Director, Analytical Development (Small Molecules)

Otsuka Pharmaceutical Co., Ltd.
Posted a day ago, valid for a month
Location

Princeton, NJ, US

Salary

$169,222 - $253,000 per year

Contract type

Full Time

Disability Insurance
Tuition Reimbursement

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Sonic Summary

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  • The Associate Director, Analytical Development (Small Molecules) will oversee analytical development activities for small molecule programs from early development to NDA submission and commercialization.
  • This role requires 12-15+ years of experience in the pharmaceutical or biotech industry, specifically in small-molecule analytical development.
  • The position offers a salary range of $169,222.00 to $253,000.00, with additional incentive opportunities based on experience and skills.
  • Key responsibilities include defining analytical strategies, managing regulatory interactions, and ensuring compliance with health authorities.
  • Candidates must possess a Ph.D. in Analytical Chemistry or a related discipline, or an M.S. with extensive relevant industry experience.

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 

Ā 

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 life‑ 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 pre‑NDAĀ meetingsĀ 

  • Analytical IR strategy and response alignmentĀ 

  • ProvideĀ analytical SMEĀ supportĀ duringĀ pre‑approvalĀ inspections (PAIs).Ā 

Analytical Risk Management & Lifecycle PlanningĀ 

  • SupportĀ risk‑basedĀ assessments and provide technical inputĀ regarding:Ā Ā 

  • Bridging vs.Ā re‑developmentĀ of analytical methodsĀ 

  • Timing and extent of method validationĀ 

  • Specification flexibility pre‑ vsĀ post‑approvalĀ 

  • Own analytical comparability andĀ post‑approvalĀ change strategies.Ā 

  • Ensure analytical approaches supportĀ long‑termĀ 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 NDA‑defensibleĀ analytical work and inspection readiness.Ā 

  • Lead escalation and resolution ofĀ high‑impactĀ analytical issues with external partners.Ā 

  • Support vendor selection, capability assessments, andĀ long‑termĀ outsourcing strategy in partnership with Quality and Procurement.Ā 

Cross‑FunctionalĀ & 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 late‑stageĀ and commercial needs.Ā 

  • Own analytical resourcing strategy, succession planning, and capability development.Ā 

Ā 

QualificationsĀ 

EducationĀ 

  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline;Ā orĀ 

  • M.S. with extensive, directly relevant industry experience.Ā 

ExperienceĀ 

  • 12–15+Ā yearsĀ of pharmaceutical or biotech industry experience inĀ small‑moleculeĀ 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/CDMO‑basedĀ 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 

Ā 

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 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: 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.

Come discover more about Otsuka and our benefit offerings;Ā https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.


Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591

Disclaimer:Ā 

Ā 

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 

Ā 

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 

Ā 

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 

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives.Ā  They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, Ā or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (ā€œOtsukaā€) does not accept unsolicited assistance from search firms for employment opportunities. Ā 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. Ā 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.Ā 




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