{"id":3002047,"url":"https://alion.io/job/arbor-biotechnologies-director-analytical-development","title":"Director, Analytical Development","company":{"id":3782935,"name":"Arbor Biotechnologies","domain":"arbor.bio","url":"https://alion.io/company/arbor-biotechnologies","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Rippling","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":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":220000,"max":240000,"currency":"USD","period":"year","gross":null,"usd_annual":240000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-28T12:55:11Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-11-09T04:11:11Z","board_verified":true,"closed_at":null,"days_open":41,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":41},"description":"Who we are.\nArbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio of first-in-class genomic medicines addressing serious diseases for which there are no existing functional cures, with a CNS pipeline initially prioritizing multiple ALS targets and a co-developed, clinical program, ABO-101, for the treatment of primary hyperoxaluria type 1. The company’s unique breadth of gene editing technologies goes beyond the limitations of early editing approaches to unlock access to new gene targets and expand the therapeutic reach of genomic medicines. For more information, please visit: arbor.bio.\nWho you are.\nYou're driven by purpose and curious by nature. You take ownership, speak up, and stay steady when things get hard. You'd rather the team win than get the credit. If that sounds like you, keep reading.\nWhy this role matters.\nArbor is seeking a Director, Analytical Development to lead phase-appropriate analytical strategy, method development, method transfer and analytical control strategy for AAV-based gene editing programs. This leader will be accountable for building and guiding analytical development capabilities that support progression from early development through clinical manufacturing, GMP readiness and regulatory submissions.\nThe Director will serve as a technical and people leader, partnering closely with Process Development, Quality, Regulatory, and external testing laboratories to ensure robust analytical methods, high-quality data, and timely program advancement.\nWhat you'll own.\nLead analytical development strategy and execution for AAV-based gene editing programs, including method development, optimization, qualification, transfer, validation support, characterization, comparability, compatibility, and stability-related testing.\nEstablish and maintain phase-appropriate analytical control strategies that support IND-enabling studies, clinical development, GMP manufacturing and release, regulatory submissions, and product lifecycle needs.\nProvide strategic and technical direction for analytical method readiness, ensuring methods are fit for purpose, scientifically justified, and prepared for transfer, qualification, and validation at appropriate development stages.\nLead development of phase-appropriate specifications, critical reagent strategies, reference standard characterization approaches, assay controls, and analytical comparability plans in partnership with Quality, Process Development, CMC and Regulatory.\nPartner with QC and external laboratories to ensure successful method transfer, GMP phase-appropriate validation, assay performance monitoring, troubleshooting, and continuous improvement.\nProvide senior technical leadership for OOS/OOT investigations, deviations, assay remediation, comparability assessments, analytical risk assessments, and method lifecycle management.\nAuthor, review, and approve analytical sections of regulatory submissions, technical reports, protocols, control strategy documents, comparability packages, and CMC source documentation.\nServe as the Analytical Development subject matter expert on cross-functional CMC and program teams, representing the function in governance forums, regulatory discussions, and external partner interactions.\nBuild, mentor, and develop a high-performing analytical development team, fostering scientific rigor, accountability, collaboration, technical excellence and compliance.\nManage priorities, resources, timelines, and external testing partners to support program goals and ensure timely delivery of high-quality analytical data.\nInfluence cross-functional decision-making by translating complex analytical data and technical risks into clear recommendations for program, manufacturing, quality, and regulatory strategy.\nWhat you've done.\nPh.D. or M.S. in biological sciences, biochemistry, analytical chemistry, pharmaceutical sciences, or a related discipline; advanced degree preferred.\n10+ years of analytical development experience in biotechnology, biologics, vaccines, gene therapy, or a related field, with significant experience supporting AAV or viral vector products.\nDemonstrated experience leading analytical development activities across multiple stages of development, including early development, IND-enabling work, clinical manufacturing support, method transfer, and GMP readiness.\nStrong technical expertise in developing, transferring, qualifying and supporting validation of methods for viral vector characterization, release, device compatibility, comparability, and stability testing.\nStrong understanding of FDA, EMA, ICH, USP, and GMP expectations related to analytical development, method validation, QC implementation, reference standards, specifications and lifecycle management.\nProven ability to lead and develop scientists, manage external testing partners, and influence stakeholders across CMC, Quality, Regulatory, Manufacturing, and Research.\nDemonstrated ability to set analytical strategy, prioritize work across programs, manage technical risk, and drive timely execution in a dynamic development environment.\nStrong scientific judgment, technical problem-solving skills, and ability to balance long-range analytical strategy with hands-on technical leadership.\nExcellent communication skills, with the ability to represent Analytical Development in governance, regulatory, technical, and external partner discussions.\nExperience supporting late-stage clinical development, analytical validation campaigns, GMP QC readiness, and regulatory submissions for AAV gene therapy products preferred.\nWhat you'll get.\nThe anticipated base salary range for this role is $220,000-$240,000. Final offers depend on experience, skills, and other job-related factors. Every employee is eligible for a bonus and new hire equity. We pay about 90% of medical, dental, and vision premiums and fund the full deductible on our HSA plan. You'll also get 12 weeks of parental leave at full pay, paid parking or transit, a 401(k) match, and discretionary time off.\nArbor is an equal opportunity employer. We're committed to a hiring process and a workplace free of bias and discrimination, and we welcome candidates of every background.","description_format":"text","description_chars":6254,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Parental leave"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Synthetic Biology","Drug Discovery"],"lifecycle":[{"event":"open","at":"2026-10-21T12:31:16Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"green card filings: 2","filings_12m":0,"filings_prev_12m":3,"green_card_filings_12m":2,"median_offered_wage_usd":87500,"route":null,"cap_exempt":false,"checked_at":"2026-11-08T10:45:15+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":22,"band":"cold","label":"Long shot","p_open":1,"p_active":0.624,"p_room":0.35,"age_days":40,"expected_fill_days":16,"reasons":["conf:2","win:tail"],"computed_at":"2026-11-08T05:47:12Z"},"pay":{"stated_usd_annual":240000,"is_top_pay":false},"html_url":"https://alion.io/job/arbor-biotechnologies-director-analytical-development","json_url":"https://alion.io/job/arbor-biotechnologies-director-analytical-development.json","meta":{"generated_at":"2026-11-09T05:47:19Z","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":1226,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"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":3782935},"rest":"https://alion.io/mcp/rest/get_company?id=3782935"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Farbor-biotechnologies-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%2Farbor-biotechnologies-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%2Farbor-biotechnologies-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/arbor-biotechnologies-director-analytical-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Farbor-biotechnologies-director-analytical-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3002047}},{"tool":"search_jobs","arguments":{"company":"arbor.bio","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3002047},"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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