{"id":2865107,"url":"https://alion.io/job/lifelancer-director-quality-analytical-technical-lead-small-molecule","title":"Director, Quality Analytical Technical Lead, Small Molecule","company":{"id":3853997,"name":"Lifelancer","domain":"lifelancer.com","url":"https://alion.io/company/lifelancer","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":true,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"inferred_payroll_markers","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":168000,"max":228000,"currency":"USD","period":"year","gross":null,"usd_annual":228000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-19T16:57:44Z","employer_posted_date":null,"last_verified_at":"2026-10-19T16:57:44Z","board_verified":false,"closed_at":null,"days_open":2,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":2},"description":"Job Title: Director, Quality Analytical Technical Lead, Small Molecule\nJob Location: Remote (US)\nJob Location Type: Remote\nJob Contract Type: Full-time\nJob Seniority Level: BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.\nGeneral Description: \nThe Analytical Technical Lead (ATL) is the single global point of contact and accountable owner for analytical lifecycle management of assigned commercial products across major markets (US, EU, China, Australia, Canada) and supports Rest of World (RoW) expansion and post-approval maintenance.\n\nAt Director level, this role is responsible for making risk-based, inspection-defensible decisions on methods, specifications, stability, and analytical investigations across a distributed internal/external QC network for small molecule products.\n\nThis leader ensures the analytical control strategy remains robust over the product lifecycle, drives harmonization, and enables reliable supply while meeting GMP, pharmacopeial, and regulatory expectations.\n\nThe Analytical Technical Lead (ATL) may own relevant global business processes, ensure compliance and efficiency. \n\nEssential Functions of the Job: A. Global Analytical Point of Contact (PoC) for Approved Commercial Products\n\nAct as the global PoC for all analytical-related matters for assigned products, to ensure analytical readiness.\n\nProvide governance and technical leadership for analytical topics spanning drug substance (DS), drug product (DP), and critical raw materials/reagents as applicable.\n\nTranslate global product strategy into aligned expectations and deliverables for internal QC sites, external QC labs/CMOs, AST, and MST.\n\nB. Analytical Lifecycle Management: Changes, Deviations, and Investigations\n\nLead and approve strategy for analytical investigations and performance issues (OOS/OOT/OOE, atypical results, invalidations), ensuring scientifically sound root cause analysis and effective CAPA, including method optimization.\n\nDrive analytical change control impact assessments and execution plans, including method updates, revalidation/verification, reference standard changes, and instrument/software upgrades.\n\nOwn escalation management for supply-critical analytical events; align actions with Quality, Regulatory, and Supply Chain.\n\nC. Global Business Process & Knowledge Owner: Methods, Specifications, Stability, Retest/Shelf Life\n\nServe as global business process and knowledge owner for:\n\nCommercial analytical method lifecycle (validation/verification strategy, transfers, periodic review, trending, method robustness improvements)\n\nGlobal specifications governance (release and stability), including harmonization and lifecycle updates\n\nStability program ownership (protocol strategy, commitments, pull schedules, trending, annual review narratives)\n\nRetest period/shelf-life governance (extensions, commitments, labeling impacts, country-specific constraints)\n\nTake over “submission-ready” documentation sources from development: analytical control strategy, method history, validation packages, specification rationale, and stability trend narratives.\n\nEnsure defensible alignment between analytical control strategy and product risk profile (CQAs/CPPs), including small-molecule impurity control.\n\nD. Regulatory Support: RoW Filings and Post-Approval Variations\n\nProvide analytical SME leadership for global regulatory submissions relevant to QC:\n\nRoW filings (Module 3 analytical sections, stability commitments, method/spec alignment)\n\nPost-approval changes (variations, supplements), including comparability narratives and analytical bridging\n\nPartner with Regulatory CMC on health authority interactions and responses related to analytical controls, stability trends, and specification justification.\n\nE. Partner and Network Oversight (Internal QC and External Labs/CMOs)\n\nProvide governance for external QC networks: align expectations, metrics, investigation quality, and issue escalation pathways (with ESQ as needed).\n\nContribute to audits/inspections as product analytical SME; ensure inspection readiness for assigned products and analytical systems.\n\nInfluence lab capacity planning and capability upgrades with a risk-based view.\n\nSupervisory Responsibilities: N/A\nEducation: \nBachelor’s degree and 10+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience required\n\nMaster’s degree and 7+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience preferred\n\nDoctoral Degree and 5+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience desired\n\nComputer Skills:Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).\n\nOther Qualifications:\nExperience \n\nDemonstrated leadership in GMP QC and/or analytical sciences for:\n\nSmall molecule methods (HPLC/UPLC, GC, dissolution, residual solvents, elemental impurities, genotox impurities as applicable)\n\nStrong working knowledge of method validation/verification, stability trends and statistical evaluation, specification lifecycle management, and data integrity.\n\nLeadership Competencies\nAbility to lead through influence in a matrix organization; strong stakeholder management and negotiation skills.\n\nStrong technical writing and ability to deliver inspection-defensible narratives.\n\nProgram and risk management mindset; ability to prioritize in supply-constrained environments.\n\nTravel: Up to 20%\nGlobal Competencies\nWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.\n\nFosters Teamwork\n\nProvides and Solicits Honest and Actionable Feedback\n\nSelf-Awareness\n\nActs Inclusively\n\nDemonstrates Initiative\n\nEntrepreneurial Mindset\n\nContinuous Learning\n\nEmbraces Change\n\nResults-Oriented\n\nAnalytical Thinking/Data Analysis\n\nFinancial Excellence\n\nCommunicates with Clarity\n\nSalary Range: $168,000.00 - $228,000.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.\nWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .\n\nThis job is curated by Lifelancer.Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.\nPlease apply via Lifelancer platform to get connected to the application page and to find similar roles.\nOriginally posted on Himalayas","description_format":"text","description_chars":8459,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Equity","Life insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Internet Services","Job Boards & Aggregators","Healthcare Staffing"],"lifecycle":[{"event":"open","at":"2026-10-19T17:28:30Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":1,"expected_fill_days":30,"reasons":["seen:1","velocity","win:early","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":228000,"is_top_pay":false},"html_url":"https://alion.io/job/lifelancer-director-quality-analytical-technical-lead-small-molecule","json_url":"https://alion.io/job/lifelancer-director-quality-analytical-technical-lead-small-molecule.json","meta":{"generated_at":"2026-10-21T19:43:01Z","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":27965,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"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":3853997},"rest":"https://alion.io/mcp/rest/get_company?id=3853997"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flifelancer-director-quality-analytical-technical-lead-small-molecule"},{"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%2Flifelancer-director-quality-analytical-technical-lead-small-molecule"},{"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%2Flifelancer-director-quality-analytical-technical-lead-small-molecule"},{"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/lifelancer-director-quality-analytical-technical-lead-small-molecule\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flifelancer-director-quality-analytical-technical-lead-small-molecule"}]}