{"id":2990648,"url":"https://alion.io/job/proclinical-analytical-development-and-validation-expert","title":"Analytical Development and Validation Expert","company":{"id":2116512,"name":"Proclinical","domain":"proclinical.com","url":"https://alion.io/company/proclinical","size_band":"201-500","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Newark, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":160000,"currency":"USD","period":"year","gross":null,"usd_annual":160000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Chromatography","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mass Spectrometry","optional":false}],"status":"live","first_seen_at":"2026-10-01T10:20:34Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-29T19:27:58Z","board_verified":true,"closed_at":null,"days_open":28,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":28},"description":"Analytical Development and Validation Expert\nBay Area - On-site\nReady to play a pivotal role in bringing innovative therapies to patients while shaping analytical strategy across a growing late-stage biotech pipeline?\nProclinical is working alongside a clinical-stage biotechnology company developing innovative medicines for serious diseases with significant unmet medical need. With multiple assets advancing through late-stage clinical development and strategic partnerships with major global pharmaceutical companies, the organisation is entering an exciting period of growth and portfolio expansion.\nAs part of a highly collaborative CMC organisation, the company is seeking an Analytical Development & Validation Expert to provide analytical leadership across drug substance and drug product development programmes.\nPrimary Responsibilities:\nThis is an excellent opportunity for an experienced analytical scientist who enjoys combining hands-on scientific expertise with strategic programme leadership.\nYou will act as a key analytical subject matter expert, working across development stages to design analytical strategies, oversee external laboratories and ensure robust analytical control throughout the product lifecycle.\nThe role offers significant visibility across CMC, Regulatory Affairs, Quality, Manufacturing and Technical Operations teams, making it ideal for someone looking to broaden their impact within a fast-moving biotechnology environment.\nSkills &Requirements:\nPhD or MSc in Analytical Chemistry or a related scientific discipline\nStrong pharmaceutical or biotechnology industry experience within Analytical Development\nExpertise in UHPLC/HPLC method development and validation\nExperience with LC-MS and advanced analytical characterisation techniques\nBackground supporting peptides, complex biologics, ADCs, proteins or related therapeutic modalities\nDemonstrated experience managing external CDMOs or analytical service providers\nExperience supporting CMC development programmes through multiple clinical stages\nUnderstanding of GMP requirements, quality systems and regulatory expectations\nRegulatory submission experience would be highly advantageous\nThe Analytical Development and Validation Expert's responsibilities will be:\nLead analytical development activities for drug substance and drug product programmes\nDevelop, optimise and validate analytical methods using modern chromatographic and spectroscopic techniques\nDesign analytical control strategies, specifications and characterisation plans\nSupport stability studies, comparability assessments and impurity characterisation activities\nManage analytical testing and development activities at external CDMOs and CROs\nReview analytical data and provide scientific guidance on investigations, deviations and troubleshooting activities\nSupport regulatory submissions including INDs, IMPDs and marketing applications\nCollaborate closely with cross-functional teams across CMC, Quality and Regulatory functions\nContribute to continuous improvement initiatives and scientific best practice across the organisation\nCompensation:\n$150,000 to $160,000 per annum.\nWhy Join?\nOpportunity to work on innovative peptide therapeutics approaching key clinical and commercial milestones\nBroad ownership and visibility across multiple development programmes\nExposure to both scientific and strategic CMC activities\nCollaborative biotech culture with direct access to senior leadership\nStrong compensation package including bonus and equity potential\nOpportunity to contribute to medicines with the potential to transform patient outcomes\nIf you are having difficulty in applying or if you have any questions, please contact Neil Walton \nIf you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.\nProclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.\nBy submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy","description_format":"text","description_chars":4337,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-21T09:47:17Z"}],"visa":[],"liveness":{"score":47,"band":"ok","label":"Likely open","p_open":1,"p_active":0.519,"p_room":0.9,"age_days":27,"expected_fill_days":45,"reasons":["conf:2","agency","velocity","win:mid","comp:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":160000,"is_top_pay":false},"html_url":"https://alion.io/job/proclinical-analytical-development-and-validation-expert","json_url":"https://alion.io/job/proclinical-analytical-development-and-validation-expert.json","meta":{"generated_at":"2026-10-29T23:01:57Z","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":34011,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":2116512},"rest":"https://alion.io/mcp/rest/get_company?id=2116512"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fproclinical-analytical-development-and-validation-expert"},{"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%2Fproclinical-analytical-development-and-validation-expert"},{"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%2Fproclinical-analytical-development-and-validation-expert"},{"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/proclinical-analytical-development-and-validation-expert\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fproclinical-analytical-development-and-validation-expert"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2990648}},{"tool":"search_jobs","arguments":{"company":"proclinical.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2990648},"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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