{"id":4256646,"url":"https://alion.io/job/otsuka-us-associate-director-analytical-development-small-molecules","title":"Associate Director, Analytical Development (Small Molecules)","company":{"id":1794798,"name":"Otsuka US","domain":"otsuka-us.com","url":"https://alion.io/company/otsuka-us","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Princeton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":169222,"max":253000,"currency":"USD","period":"year","gross":null,"usd_annual":253000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Gmail","optional":false},{"name":"HPLC","optional":false},{"name":"ICH Guidelines","optional":false}],"status":"live","first_seen_at":"2026-09-01T00:00:00Z","employer_posted_date":"2026-09-01","last_verified_at":"2026-11-13T14:14:21Z","board_verified":true,"closed_at":null,"days_open":73,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":73},"description":"Position Summary\nThe 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.\nAssociate 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.\nKey Responsibilities\nPortfolioLevel Analytical Strategy & Governance\nContribute and executeanalytical strategies for a portfolio of smallmolecule programs spanningearly development through NDA and commercialization.\n\nEstablish consistent,riskbasedapproaches for:\n\nMethodlifecycle evolution\n\nSpecification setting and tightening\n\nStability strategy andshelf life-justification\n\nProvidesanalyticalrecommendations and executesagreestrategies, with accountability for regulatory outcomes.\n\nNDA Ownership & Regulatory Leadership\nOwn the analytical narrative and positioning for NDAs, ensuring coherence across:\n\nDrug substance (3.2.S)\n\nDrug product (3.2.P)\n\nImpurities, stability, and control strategies\n\nReview, approve, and integrate analytical content authored by Senior Managers and external partners.\n\nSupport andparticipateinanalytical interactions with FDA and global Health Authorities, including:\n\nNDA review discussions\n\nType C andpre-NDAmeetings\n\nAnalytical IR strategy and response alignment\n\nProvideanalytical SMEsupportduringpre - approvalinspections (PAIs).\n\nAnalytical Risk Management & Lifecycle Planning\nSupportrisk-basedassessments and provide technical inputregarding:\n\nBridging vs.re-developmentof analytical methods\n\nTiming and extent of method validation\n\nSpecification flexibility pre-vspost-approval\n\nOwn analytical comparability andpost-approvalchange strategies.\n\nEnsure analytical approaches supportlong-termcommercial robustness and global regulatory compliance.\n\nCDMO & External Partner Strategy\nSupport withdefiningand implementinganalytical governance models for CDMOs and CROs.\n\nSet expectations forNDA-defensibleanalytical work and inspection readiness.\n\nLead escalation and resolution ofhigh-impactanalytical issues with external partners.\n\nSupport vendor selection, capability assessments, andlong-termoutsourcing strategy in partnership with Quality and Procurement.\n\nCross -Functional& CMC Leadership\nAct as a strategic thought partnertoRegulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain.\n\nInfluenceCMC development strategy and timelines through analytical risk assessment and mitigation planning.\n\nRepresent Analytical Development in CMC governance forums and leadership discussions.\n\nPeople Leadership & Capability Building\nMentorSenior Managers and Managers; coach leaders rather than individual contributors.\n\nBuild and scale analytical capabilities aligned withlate-stageand commercial needs.\n\nOwn analytical resourcing strategy, succession planning, and capability development.\n\nQualifications\nEducation\nPh.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline;or\n\nM.S. with extensive, directly relevant industry experience.\n\nExperience\n12-15+years of pharmaceutical or biotech industry experience insmall -moleculeanalytical development.\n\nDemonstrated leadership of programs fromearly development through NDA filing and approval.\n\nDemonstratedexperience contributingtoofNDA analytical strategy and Health Authority engagement.\n\nExperience leading analytical functions inoutsourced/CDMO -baseddevelopment models.\n\nTechnical & Regulatory Expertise\nDeepexpertisein:\n\nStabilityindicatingmethods (HPLC/UPLC, GC, dissolution)\n\nImpurity control (ICH Q3A/B, Q3C, genotoxic impurities)\n\nSolidstate characterization and stability (XRPD, DSC, TGA)\n\nStrong command ofICH Q1, Q2,Q6A and FDA expectations for NDAs.\n\nDemonstrated ability to develop analytically robust,inspectionreadycontrol strategies.\n\nLeadership Competencies\nStrategic thinker with strongriskbaseddecisionmaking capability.\n\nInfluential leader in matrixed organizations.\n\nClear, authoritative communicator with strong regulatory writing and presentation skills.\n\nProven ability to balance speed, risk, cost, and compliance.\n\nCompetencies\nAccountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.\nStrategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.\nPatient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.\nImpactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.\nRespectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.\nEmpowered Development - Play an active role in professional development as a business imperative.\nMinimum $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.\nCompany 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.\nCome discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.\nJoin 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\nDisclaimer:\nThis 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.\nOtsuka 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.\nIf 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 .\nStatement Regarding Job Recruiting Fraud Scams\nAt 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. 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.\nPlease 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.\nOtsuka 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.\nTo 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.\nOtsuka 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, or your local authorities.\nOtsuka 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.","description_format":"text","description_chars":10594,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible time off","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care"],"lifecycle":[{"event":"open","at":"2026-11-13T14:14:21Z"}],"visa":[],"liveness":{"score":20,"band":"cold","label":"Long shot","p_open":1,"p_active":0.718,"p_room":0.28,"age_days":73,"expected_fill_days":26,"reasons":["conf:1","win:tail","crowd:brand"],"computed_at":"2026-11-13T15:50:46Z"},"pay":{"stated_usd_annual":253000,"is_top_pay":false},"html_url":"https://alion.io/job/otsuka-us-associate-director-analytical-development-small-molecules","json_url":"https://alion.io/job/otsuka-us-associate-director-analytical-development-small-molecules.json","meta":{"generated_at":"2026-11-13T15:50:46Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":31761,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1794798},"rest":"https://alion.io/mcp/rest/get_company?id=1794798"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fotsuka-us-associate-director-analytical-development-small-molecules"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fotsuka-us-associate-director-analytical-development-small-molecules"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fotsuka-us-associate-director-analytical-development-small-molecules"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/otsuka-us-associate-director-analytical-development-small-molecules\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fotsuka-us-associate-director-analytical-development-small-molecules"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4256646}},{"tool":"search_jobs","arguments":{"company":"otsuka-us.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4256646},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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