{"id":4053796,"url":"https://alion.io/job/avalotx-director-analytical-development","title":"Director, Analytical Development","company":{"id":3783009,"name":"AvaloTx","domain":"avalotx.com","url":"https://alion.io/company/world-19","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Chesterbrook, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mass Spectrometry","optional":false},{"name":"LIMS","optional":true}],"status":"live","first_seen_at":"2026-09-10T13:29:48Z","employer_posted_date":"2026-11-09","last_verified_at":"2026-11-11T03:26:54Z","board_verified":true,"closed_at":null,"days_open":61,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":61},"description":"At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process.\nWe share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.\nPosition Summary:\nThe Director, Analytical Development will provide technical and strategic leadership for analytical development, characterization, method lifecycle management, and testing strategies supporting the Company's biologics programs, with primary responsibility for supporting late-stage clinical development and advancing programs toward commercial readiness. This individual will serve as the Company's analytical development subject matter expert and primary technical representative with external laboratories, Contract Development and Manufacturing Organizations (CDMOs), and Contract Research Organizations (CROs), supporting all phases of clinical development with a focus on Phase 3 clinical supply, process characterization and validation, comparability, specifications, stability, method qualification/validation and transfer, regulatory submissions, PPQ, and preparation for commercial manufacturing.\nThe Director will partner closely with Upstream and Downstream Manufacturing, Quality, Regulatory Affairs, Supply Chain, Program Management, and external analytical and QC partners to ensure analytical methods and control strategies are scientifically sound, phase-appropriate, compliant, robust, and suitable for commercialization. The role requires strong scientific judgment, ownership, and the ability to influence and drive results in a lean, highly outsourced operating model.\nESSENTIAL DUTIES AND RESPONSIBILITIES:\nLate-Stage Analytical Development and Commercial Readiness\nProvide technical and strategic leadership for analytical development activities supporting all phases of clinical development and progression toward commercial manufacturing.\nDevelop and execute analytical strategies generating and implementing new specifications, supporting clinical supply, process characterization, PPQ/process validation, regulatory submissions, and commercial launch.\nLead development and implementation of phase-appropriate analytical control strategies for biologic drug substance and drug product.\nDrive analytical method development, optimization, qualification, validation, transfer, and lifecycle management.\nEnsure analytical methods are appropriate for their intended use and capable of supporting product release, stability, characterization, comparability, and process validation activities.\nPartner with Quality and Regulatory CMC to establish and justify appropriate specifications for drug substance, drug product, intermediates, and other relevant materials.\nProvide analytical leadership supporting PPQ and commercial readiness activities.\nAnalytical Characterization and Product Understanding\nLead analytical characterization strategies to establish and maintain comprehensive understanding of product quality attributes.\nDevelop and oversee analytical approaches for evaluating identity, purity, contamination, potency, strength, charge variants, size variants/aggregates, glycosylation, post-translational modifications, and process- and product-related impurities, as applicable.\nPartner with Process Development and Manufacturing to establish relationships between process parameters and critical quality attributes (CQAs).\nLead analytical strategies supporting comparability assessments associated with manufacturing process, scale, site, formulation, raw material, or other changes.\nEnsure appropriate use of orthogonal analytical methods to characterize product structure, function, purity, and biological activity.\nEvaluate analytical data and product quality trends to identify potential risks or changes in product performance.\nExternal Laboratory, CRO, and CDMO Leadership\nServe as the Company's analytical technical lead and subject matter expert with external testing laboratories, CROs, and CDMOs.\nLead technical evaluation, selection, qualification, governance, and ongoing performance management of analytical partners.\nOversee outsourced analytical development, method validation, method transfer, characterization, Quality control release, and stability testing activities.\nReview analytical protocols, methods, specifications, validation plans and reports, stability protocols, investigations, and technical reports.\nEstablish strong technical relationships with external analytical development, QC, manufacturing, quality, and project management teams; appropriately challenge and escalate analytical, quality, timeline, or execution risks.\nProvide technical input to scopes of work, agreements, change orders, and vendor discussions related to analytical requirements and capabilities.\nAnalytical Method Development, Validation, Transfer, and Lifecycle Management\nLead development, optimization, qualification, and validation of analytical methods supporting biologic drug substance and drug product.\nEstablish analytical method validation strategies consistent with applicable ICH, FDA, EMA, and compendial expectations.\nLead analytical method transfers between development laboratories, CROs, CDMOs, QC laboratories, and commercial testing sites.\nEnsure effective transfer of analytical knowledge, methods, acceptance criteria, reference standards, system suitability requirements, and technical procedures.\nMonitor method performance following transfer and validation and identify opportunities for appropriate method improvements.\nDevelop and maintain analytical method lifecycle strategies supporting late-stage development through commercialization.\nStability and Specification Strategy\nProvide technical leadership for stability strategies supporting clinical development, regulatory submissions, and commercialization.\nPartner with Quality and Regulatory CMC to develop scientifically justified specifications and acceptance criteria.\nReview and interpret stability data, generate trends, support excursions, and out-of-specification or out-of-trend results.\nSupport establishment and justification of shelf life, storage conditions, and relevant stability commitments.\nEnsure stability programs appropriately support regulatory filing and commercial requirements.\nAnalytical Troubleshooting and Investigations\nProvide technical leadership for analytical investigations, including OOS, OOT, atypical results, method performance issues, and laboratory deviations.\nLead or support root-cause investigations and development of scientifically sound corrective and preventive actions.\nEvaluate analytical trends and method performance to proactively identify potential risks.\nPartner with Quality, Manufacturing, and external laboratories to ensure timely investigation and resolution of analytical issues that could impact clinical supply or program timelines.\nAssess analytical changes for potential comparability, validation, product quality, and regulatory impact.\nQuality and Regulatory Leadership\nEnsure analytical development activities comply with applicable cGMP, ICH, FDA, EMA, pharmacopeial, and internal quality requirements.\nProvide technical review and approval, as appropriate, of analytical methods, validation protocols and reports, specifications, stability protocols, investigations, change controls, CAPAs, risk assessments, and technical reports.\nServe as the analytical development SME for regulatory submissions and health authority interactions.\nLead or contribute to preparation and review of relevant IND/IMPD/BLA/MAA CMC analytical sections, including analytical procedures, method validation, specifications, characterization, stability, and comparability content.\nSupport responses to health authority questions related to analytical methods, specifications, stability, product characterization, and control strategy.\nSupport regulatory inspections, partner audits, and pre-approval inspection readiness for analytical activities.\nCross-Functional CMC Leadership and Risk Management\nPartner closely with Upstream and Downstream Manufacturing to ensure analytical strategies appropriately support process development, process characterization, technology transfer, manufacturing investigations, and PPQ.\nCollaborate with Quality Assurance, Quality Control, Regulatory Affairs, Process Development, Supply Chain, and CMC leadership to advance program objectives.\nProactively identify analytical, testing capacity, method, reference standard, stability, vendor, and regulatory risks that could impact Phase 3 clinical supply or commercial readiness; develop and drive mitigation and contingency strategies.\nProvide clear scientific assessments, risk evaluations, recommendations, and decision options to CMC and senior management.\nTrack key analytical deliverables, timelines, risks, and external partner performance and ensure timely escalation and resolution of issues.\nREQUIRED EDUCATION AND EXPERIENCE:\nPh.D., M.S., or B.S. in Analytical Chemistry, Biochemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, Biology, or a related scientific discipline.\n10+ years of progressive biopharmaceutical industry experience in analytical development, characterization, Quality Control, and/or CMC development; equivalent combinations of education and experience will be considered.\nDemonstrated experience supporting late-stage biologics development, including Phase 3 programs and progression toward regulatory filing and commercial readiness.\nSignificant experience developing and implementing analytical strategies for biologic drug substance and/or drug product.\nExperience with monoclonal antibodies, recombinant proteins, or other biologic products.\nDemonstrated experience with analytical method development, qualification, validation, transfer, and lifecycle management.\nExperience supporting product characterization, specifications, stability, comparability, and process validation/PPQ.\nDemonstrated experience managing analytical activities at external CROs, CDMOs, and/or testing laboratories.\nExperience supporting analytical investigations, troubleshooting, OOS/OOT assessments, and change management in a regulated environment.\nWorking knowledge of ICH, FDA, EMA, cGMP, and biologics analytical regulatory requirements.\nTechnical Expertise\nAnalytical method development, qualification, validation, transfer, and lifecycle management.\nBiologic drug substance and drug product characterization.\nChromatographic methods including HPLC/UPLC, SEC, ion-exchange chromatography, and reversed-phase chromatography.\nElectrophoretic methods including CE-SDS, capillary isoelectric focusing/imaged CIEF, and related technologies.\nMass spectrometry and other structural characterization methodologies.\nProtein concentration, identity, purity, and impurity testing.\nAggregate and size-variant analysis; charge-variant analysis; glycan and post-translational modification characterization.\nPotency and biological activity assays, including appropriate cell-based and/or binding assays.\nProcess- and product-related impurity testing, including host cell protein and residual DNA, as applicable.\nStability-indicating methods and stability data interpretation.\nAnalytical comparability strategies; reference standard qualification and lifecycle management; specification development and justification.\nADDITIONAL SKILLS, KNOWLEDGE, AND/OR ABILITIES:\nStrong scientific and technical leadership with sound analytical judgment.\nAbility to integrate complex analytical data into clear conclusions and development recommendations.\nStrategic thinking with the ability to antici...","description_format":"text","description_chars":15218,"description_truncated":true,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Hybrid work"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Financial Services","Health Care","Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-11-11T03:26:54Z"}],"visa":[],"liveness":{"score":17,"band":"cold","label":"Long shot","p_open":1,"p_active":0.604,"p_room":0.28,"age_days":61,"expected_fill_days":29,"reasons":["conf:1","win:tail","crowd:"],"computed_at":"2026-11-11T04:43:07Z"},"pay":null,"html_url":"https://alion.io/job/avalotx-director-analytical-development","json_url":"https://alion.io/job/avalotx-director-analytical-development.json","meta":{"generated_at":"2026-11-11T04:43:07Z","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":5504,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"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":3783009},"rest":"https://alion.io/mcp/rest/get_company?id=3783009"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Favalotx-director-analytical-development"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Favalotx-director-analytical-development"},{"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%2Favalotx-director-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/avalotx-director-analytical-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Favalotx-director-analytical-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4053796}},{"tool":"search_jobs","arguments":{"company":"avalotx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4053796},"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); 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