{"id":3953652,"url":"https://alion.io/job/direct-biologics-scientist-process-sciences-analytical-development","title":"Scientist, Process Sciences - Analytical Development","company":{"id":4474737,"name":"Direct Biologics","domain":"directbiologics.com","url":"https://alion.io/company/direct-biologics","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Poway, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"GMP","optional":false},{"name":"CAPA","optional":true},{"name":"Chromatography","optional":true},{"name":"ELISA","optional":true},{"name":"HPLC","optional":true},{"name":"Next-Generation Sequencing","optional":true},{"name":"PCR","optional":true},{"name":"qPCR","optional":true}],"status":"live","first_seen_at":"2026-09-15T00:00:00Z","employer_posted_date":"2026-09-15","last_verified_at":"2026-11-09T06:18:14Z","board_verified":true,"closed_at":null,"days_open":55,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":55},"description":"Direct Biologics is a science-based market leading innovator and certified cGMP manufacturer of regenerative biologic products driven by science and innovation. Our company is dedicated to delivering cutting-edge clinical and scientific solutions through meticulous research efforts. Direct Biologics prioritizes patient safety above all else. All regulated processes adhere to cGxP standards, guaranteeing the utmost safety and quality at every phase of product development. Direct Biologics delivers high-quality products for healthcare providers and patients alike. Our commitment to excellence is upheld through our quality systems, ensuring the consistent provision of safe products. Direct Biologics was established with the goal of advancing the frontier of cutting-edge human cell and tissue technologies. Our company has amassed substantial intellectual property focused on stem cell secretomes and their applications.\nRequirements\nSome required skills for the Scientist position:\nExperience with one or more of the following is desirable:\nPCR/qPCR/ddPCR \nELISA and other ligand-binding assays\nAssays for biomolecular activity and function\nBiophysical particle characterization\nCell-based and functional assays\nSpectrophotometric and fluorescence-based methods\nHPLC/UPLC and other chromatographic techniques\nNext Generation Sequence (NGS)\nCompendial testing, including pH, osmolality, appearance, endotoxin, bioburden, and sterility\nStatistical analysis and analytical software\nPrimary Roles and Responsibilities:\nPosition Summary:\nThe Analytical Scientist develops, validates, transfers, and supports analytical methods for the characterization, release, stability, and process development of biopharmaceutical products. The primary technical focus is on molecular biology, biochemistry and cell biology, including, but not limited to PCR, ELISA, next-generation sequencing (NGS), EV and particle characterization, and assays for biomolecular activity and function. The role provides scientific and technical expertise throughout the product lifecycle and collaborates closely with R&D, Process Sciences, Quality Control, Quality Assurance, Manufacturing, Regulatory/CMC, and external laboratories.\nKey Responsibilities:\nAnalytical Development and Characterization\nDevelop, optimize, qualify/validate, transfer, and troubleshoot analytical methods for biologics, with a focus on molecular biology and biochemistry, including PCR, ELISA, next-generation sequencing (NGS), and assays of biomolecular activity and function. \nDesign, optimize and execute analytical method development, validation, bridging, comparability, and transfer studies using appropriate molecular biology and biochemical technologies.\nEstablish method parameters, system suitability criteria, acceptance criteria, and assay controls.\nEvaluate method performance and investigate sources of analytical variability.\nDesign and execute forced degradation studies to understand degradation pathways and support stability-indicating methods.\nSupport characterization of biological drug substances, drug products, intermediates, and process-related samples.\nEvaluate analytical data to support product/process understanding, CQAs, and release and stability specifications.\nGMP and Manufacturing Support\nSupport analytical readiness, release, and stability testing for GMP manufacturing.\nLead or participate in GMP investigations, including OOS/OOT and unexpected analytical results, root-cause analysis, and product-impact assessments.\nProvide technical support for deviations, change controls, CAPAs, and other quality-system activities.\nEnsure analytical activities comply with applicable GMP and data-integrity requirements.\nMethod Transfer and External Laboratories\nLead or support method transfers to QC and external laboratories.\nProvide technical oversight of CROs, CMOs/CDMOs, and contract testing laboratories.\nReview protocols, methods, data, validation reports, technical reports and troubleshoot method-performance issues.\nDocumentation, Regulatory, and Collaboration\nAuthor and review analytical methods, protocols, reports, specifications, SOPs, and technical assessments.\nSupport CMC/regulatory submissions and health authority responses by providing accurate and scientifically justified analytical content consistent with applicable FDA, ICH, USP, and other relevant requirements.\nServe as a key analytical partner to R&D, Process Sciences, and QC, facilitating transfer of product knowledge and analytical methods from research through development and into GMP testing.\nPartner with R&D on assay development, characterization, and forced degradation studies and with QC on method transfer, validation, troubleshooting, investigations, and GMP readiness.\nProvide analytical subject-matter expertise and technical content to support CMC regulatory submissions, including analytical procedures, method validation, specifications, batch analysis, stability, and justification of specifications, as applicable. \nProvide analytical assessments and supporting documentation for regulatory responses, information requests, and health authority interactions, as needed. \nAssess analytical method, specification, and testing changes for potential impact to established regulatory commitments and provide technical input to Regulatory/CMC and Quality through the change-control process.\nQualifications:\nPh.D. in a relevant scientific discipline with 2-5 years of industry experience; or M.S./B.S. with 5-8 years of relevant biotechnology or pharmaceutical industry experience.\nExperience in analytical development, validation, transfer, and characterization of biologics.\nExperience translating research-stage assays into methods suitable for product development and GMP use.\nKnowledge of forced degradation and stability-indicating method principles.\nWorking knowledge of GMP analytical testing, pharmaceutical quality systems, and applicable ICH, FDA, and USP requirements.\nExperience with GMP investigations, OOS/OOT, deviations, change controls, and CAPAs is desirable.\nExperience working with external laboratories, CROs, or CMOs/CDMOs is preferred.\nStrong scientific problem-solving, data interpretation, technical writing, project management, and cross-functional collaboration skills.\nStrong sense of ownership, accountability, and urgency in driving tasks and projects to completion.\nBenefits\n Health Care Plan (Medical, Dental & Vision)\n Company 401k match up to 4%\n Paid Time Off (Vacation & Sick) \n Holidays\n Stock Option","description_format":"text","description_chars":6514,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-11-09T06:18:14Z"}],"visa":[],"liveness":{"score":20,"band":"cold","label":"Long shot","p_open":1,"p_active":0.362,"p_room":0.55,"age_days":55,"expected_fill_days":39,"reasons":["conf:1","win:tail"],"computed_at":"2026-11-09T07:57:19Z"},"pay":null,"html_url":"https://alion.io/job/direct-biologics-scientist-process-sciences-analytical-development","json_url":"https://alion.io/job/direct-biologics-scientist-process-sciences-analytical-development.json","meta":{"generated_at":"2026-11-09T07:57:19Z","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":5743,"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":4474737},"rest":"https://alion.io/mcp/rest/get_company?id=4474737"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fdirect-biologics-scientist-process-sciences-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%2Fdirect-biologics-scientist-process-sciences-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%2Fdirect-biologics-scientist-process-sciences-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/direct-biologics-scientist-process-sciences-analytical-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fdirect-biologics-scientist-process-sciences-analytical-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3953652}},{"tool":"search_jobs","arguments":{"company":"directbiologics.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3953652},"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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