{"id":2362855,"url":"https://alion.io/job/us-worldmeds-principal-scientist-vector-msat","title":"Principal Scientist (Vector) - MSAT","company":{"id":2540669,"name":"US WorldMeds","domain":"usworldmeds.com","url":"https://alion.io/company/usworldmeds","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Philadelphia, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":197000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":541},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-15T19:51:00Z","employer_posted_date":"2026-09-15","last_verified_at":"2026-10-27T07:02:32Z","board_verified":true,"closed_at":null,"days_open":41,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":41},"description":"SUMMARY:\nThe Principal Scientist (Vector) - Manufacturing Sciences and Technology will be responsible for designing, leading, executing and overseeing internal and external studies and teams to support product and process optimization and automation, aseptic process validation and requalification campaigns, technology transfer activities, BLA supporting process and product characterization studies, BLA authoring, investigation into deviations and root cause analysis, change management and any activities required by the MS&T organization. This position bridges deep viral-vector knowledge with external manufacturing management and internal DS/DP manufacturing ensuring outsourced vector production (LVV) meets yield, quality, and regulatory requirements.\nDUTIES AND RESPONSIBILITIES:\nThe following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign\nduties and responsibilities to this job at any time due to reasonable accommodation or other reasons.\nProvide technical leadership and support for technology transfer, process optimization, and technology evaluation to support development and commercialization of new and existing products.\nDevelop, qualify, and execute phase-appropriate studies for the characterization and development of multiple pipeline products\nLeads process lifecycle management for both commercial and approaching BLA CGT programs.\nCollaborate with Quality Assurance, Regulatory Affairs, Analytical Sciences, Supply Chain, and Facilities to align strategic priorities and project timelines.\nUtilize statistical process control tools to monitor manufacturing metrics, prepare continued process verification reports, and ensure inspection readiness.\nMentor junior scientist and foster a culture of collaboration and technical excellence. May manage a small to mid-sized team\nRepresent Manufacturing Sciences and Technology team in cross-functional technical meetings.\nAseptic process lead and oversight: coordinate across multi disciplines, including QA, QC Micro, Manufacturing, MS&T, Regulatory, Engineering, for aseptic process validation activities, ensuring timely execution and audit readiness.\nProvide aseptic process technical expertise and guidance for risk assessments, validation documentation.\nAct as SME for sterility assurance topics, supporting investigation and leading continuous improvement to improve the aseptic simulation program.\nFacilitate product transfers by aligning aseptic validation approaches.\nReview and approve change controls, ensuring validation impact assessments, and appropriate testing to maintain validated states.\nSupport the execution of improvement projects, liaising with all the relevant parties to ensure accurate execution.\nSupport with any internal or external audit.\nLifecycle management:\nLentiviral process subject matter expert (SME) for deviations, root cause investigations, root-cause analyses, and CAPAs related to LVV vector production.\nManage lentiviral vector manufacturing process lifecycle governance.\nEvaluate lentiviral manufacturing process changes, shipping validation parameters, deviations, and out-of-trend events.\nInterface with contract development and manufacturing organizations for external lentivirus production.\nAuthor, review, and defend lentiviral vector process\nQUALIFICATIONS:\nRequired:\nB.S., M.S. or Ph.D. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 4 years (PhD), 8 years (M.S.) or 10 years (B.S.) of industry experience.\nProven understanding of aseptic techniques, FDA/EU regulatory requirements and guidelines for validation.\nKnowledge and experience in developing manufacturing processes with understanding of regulatory constraints relating to cGMP, Annex 1, and ATMP guidance.\nExperience in working in cross-functional environments, and with internal/external partners to perform process transfer for cGMP production.\nProficiency in project management and resource planning • Strong understanding of adeno-associated virus (AAV), or lentivirus vector (LVV) production is required\nDesirable:\nExperience managing or providing oversight of CROs/CMOs\nExperience with regulatory submissions (IND, BLA, MAA) for advanced therapies.\nProficiency in Quality by Design (QbD) principles and statistical data analysis.\nThe physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nPHYSICAL DEMANDS:\nFrequently required to stand\nFrequently required to walk.\nFrequently required to sit.\nFrequently required to talk or hear.\nOccasionally required to lift light weights (less than 25 pounds)\nSpecific vision abilities required for this job include: close vision, color vision and ability to adjust or focus","description_format":"text","description_chars":4982,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Prescription Drugs","Pharmacies"],"lifecycle":[{"event":"open","at":"2026-10-12T16:08:03Z"}],"visa":[],"liveness":{"score":30,"band":"fade","label":"Fading","p_open":1,"p_active":0.664,"p_room":0.45,"age_days":41,"expected_fill_days":27,"reasons":["conf:7","win:tail"],"computed_at":"2026-10-27T05:46:45Z"},"pay":null,"html_url":"https://alion.io/job/us-worldmeds-principal-scientist-vector-msat","json_url":"https://alion.io/job/us-worldmeds-principal-scientist-vector-msat.json","meta":{"generated_at":"2026-10-27T10:40:42Z","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":12385,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":2540669},"rest":"https://alion.io/mcp/rest/get_company?id=2540669"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fus-worldmeds-principal-scientist-vector-msat"},{"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%2Fus-worldmeds-principal-scientist-vector-msat"},{"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%2Fus-worldmeds-principal-scientist-vector-msat"},{"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/us-worldmeds-principal-scientist-vector-msat\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fus-worldmeds-principal-scientist-vector-msat"}]}