{"id":2982679,"url":"https://alion.io/job/sk-life-science-associate-director-cmc-analytical-development","title":"Associate Director, CMC Analytical Development","company":{"id":3143012,"name":"SK Life Science","domain":"sklifescienceinc.com","url":"https://alion.io/company/sklifescienceinc","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Paramus, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":190000,"currency":"USD","period":"year","gross":null,"usd_annual":190000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Mass Spectrometry","optional":false}],"status":"live","first_seen_at":"2026-10-21T07:47:33Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-26T10:33:45Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Overview\nLead analytical development for small-molecule API and based drug products from IND-enabling studies through NDA readiness in a virtual, outsourced model.\n Direct analytical methods, stability, specifications, impurity controls, and performance testing for drug substance and drug product.\n Manage CDMOs, CROs, budgets, and submissions against clinical and regulatory timelines.\nResponsibilities\nAnalytical Development\nDrive overall control strategy and Justification of specification for release and stability\nDevelop phase-appropriate analytical and control strategies for drug substance, excipients, intermediates, and drug products focused on oral dosage forms.\nOversee method development, transfer, validation, and lifecycle management for assay, impurities, chiral purity, water, and physical characterization.\nLead residual-solvent risk assessment and controls, including headspace GC, and elemental-impurity risk assessments and testing, including ICP-MS, in line with ICH requirements.\nDirect ICH stability, forced-degradation, reference-standard, specification, comparability, and shelf-life activities.\nSet extractables and leachables strategies for container-closure and product-contact materials; oversee external GC-MS, LC-MS, and ICP-MS studies.\nDefine analytical testing requirement for container closure involved\nDefine microbiological and antimicrobial related requirements\nGuide cleaning verification related method development\nSupport analytical methods required in any other formulation and process development\nInvolve in management of reference standards and API inventory required at CDMO\nDissolution and Biopharmaceutics\n Develop discriminating and, when appropriate, biorelevant dissolution methods for oral dosage forms across BCS Classes I-IV.\n Assess apparatus, media, pH, surfactant, sink conditions, precipitation risk, particle size, solid form, formulation variables, and manufacturing-process parameters.\n Support clinically relevant specifications, dissolution-profile comparisons, formulation and site bridging, in vitro-in vivo relationships, and BCS-based biowaiver strategies.\nExternal Partner and Quality Oversight\n Select and govern CDMOs, CROs, and testing laboratories; define scopes, review proposals, manage timelines and budgets, and monitor technical performance.\n Review protocols, methods, specifications, reports, certificates of analysis, validation packages, stability data, and batch documentation.\n Lead OOS, OOT, deviation, change-control, CAPA, and data-integrity investigations; support vendor audits and inspection readiness.\nRegulatory and Compendial Compliance\n Apply cGMP, applicable ICH guidance, and dosage-form requirements in USP-NF, Ph. Eur., JP, and other relevant pharmacopoeias to methods, specifications, and control strategies.\n Author and review analytical CMC content for INDs, IMPDs, NDAs, amendments, annual reports, briefing documents, and health-authority responses.\n Prepare CTD Module 3 analytical sections covering specifications, procedures, validation, batch analyses, impurities, reference standards, dissolution, container-closure systems, and stability.\n Cross Functional Leadership\n Represent Analytical Development on CMC program teams and communicate risks, recommendations, timelines, and resource needs to internal leaders and external partners.\n Collaborate with formulation, process chemistry, manufacturing, quality, regulatory, toxicology, packaging, clinical supply, project management, and finance.\nQualifications\nBachelor's degree or equivalent with a minimum of 12 years of relevant experience, or Pharm.D., master's degree, or Ph.D. with at least 8 years of relevant experience.\nAnalytical development experience with small-molecule drug substances and oral drug products from early development through late-stage or NDA readiness.\n Experience with HPLC/UPLC, GC/headspace GC, LC-MS, GC-MS, ICP-MS, dissolution, stability-indicating methods, residual solvents, elemental impurities, and extractables and leachables.\n Experience developing discriminating dissolution methods and applying BCS principles to compounds with varied solubility and permeability.\n Strong knowledge of cGMP, ICH guidance, and compendial requirements for oral dosage forms, including USP-NF, Ph. Eur., and JP.\n Direct experience authoring and reviewing analytical CTD Module 3 content for INDs, IMPDs, and NDAs.\nDemonstrated oversight of outsourced laboratories and CDMOs, including method transfer, investigations, timelines, budgets, and vendor performance.\nManage multiple priorities and adapt to changing program needs.\n Communicate clearly in writing and in cross-functional meetings.\n Exercise sound scientific judgment and close attention to detail.\nWork effectively under schedule pressure in a virtual environment.\nPeriodic travel to CDMOs, contract laboratories, manufacturing sites, and company meetings may be required.\nCompensation & Benefits\nThe anticipated salary range for this position is $150,000 to $190,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.\nIn addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.","description_format":"text","description_chars":5386,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-10-21T07:47:33Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":4,"expected_fill_days":30,"reasons":["conf:3","velocity","win:early"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":190000,"is_top_pay":false},"html_url":"https://alion.io/job/sk-life-science-associate-director-cmc-analytical-development","json_url":"https://alion.io/job/sk-life-science-associate-director-cmc-analytical-development.json","meta":{"generated_at":"2026-10-26T15:21:18Z","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":20451,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":3143012},"rest":"https://alion.io/mcp/rest/get_company?id=3143012"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsk-life-science-associate-director-cmc-analytical-development"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fsk-life-science-associate-director-cmc-analytical-development"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fsk-life-science-associate-director-cmc-analytical-development"},{"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/sk-life-science-associate-director-cmc-analytical-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsk-life-science-associate-director-cmc-analytical-development"}]}