{"id":3853872,"url":"https://alion.io/job/planet-pharma-downstream-manufacturing-associate-iii","title":"Downstream Manufacturing Associate III","company":{"id":4467183,"name":"Planet Pharma","domain":"planet-pharma.com","url":"https://alion.io/company/planet-pharma","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"B","score":80,"open_postings":11,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-11-08T05:47:12Z"}},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Pennington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-05T00:00:00Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-08T21:55:28Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Pay range: 30-40/hr\n*depending on experience\nPosition Overview:\nThe Downstream Manufacturing Associate III (Lead) provides technical leadership and operational coordination for downstream manufacturing activities within a cGMP environment. This role is responsible for leading purification operations, supporting manufacturing readiness, troubleshooting complex process issues, coordinating cross-functional activities, and driving operational excellence initiatives while ensuring successful batch execution.\nKey Responsibilities:\nManufacturing Leadership\n* Lead daily downstream manufacturing operations and provide shop-floor technical support.\n* Coordinate execution of manufacturing campaigns and purification schedules.\n* Ensure manufacturing readiness, equipment availability, and material preparedness for batch execution.\n* Serve as the primary technical resource during downstream manufacturing operations.\n* Provide real-time decision support during process execution and batch recovery activities.\nDownstream Processing\n* Lead all purification operations including Protein A capture, viral inactivation, ion exchange chromatography, UF/DF, viral filtration, and final bulk drug substance processing.\n* Oversee operation and performance of chromatography skids, AKTA systems, BioSC, TFF systems, and filtration equipment.\n* Monitor critical process parameters and ensure adherence to process specifications.\n* Troubleshoot process and equipment issues to maintain operational continuity.\n* Support implementation of process improvements and manufacturing optimization efforts.\nDocumentation & Compliance\n* Lead preparation and revision of: \no Standard Operating Procedures (SOPs)\no Master Batch Records (MBRs)\no Manufacturing Forms and Logbooks\no Equipment and Process Documentation\n* Support deviation investigations, CAPAs, change controls, and risk assessments.\n* Ensure continuous inspection readiness and GMP compliance.\n* Participate directly in regulatory inspections and client audits.\n* Support review and approval of manufacturing documentation for batch release readiness.\nCross-Functional Coordination\n* Coordinate activities between Manufacturing, QA, QC, MSAT, Validation, Engineering, Facilities, Warehouse, and Supply Chain teams.\n* Support technology transfer projects from process development through GMP manufacturing.\n* Participate in process validation, PPQ campaigns, and commercial manufacturing programs.\n* Lead manufacturing readiness reviews and campaign planning meetings.\n* Drive continuous improvement and operational excellence initiatives.\nCoaching & Development\n* Train, mentor, and develop Associate I and Associate II personnel.\n* Provide technical coaching and floor-based leadership.\n* Support qualification programs and onboarding activities.\n* Assist supervisors with scheduling, work assignments, and personnel development plans.\nQualifications:\nEducation & Experience\n* Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 5+ years of relevant biopharmaceutical manufacturing experience.\n* Previous lead operator, project coordination, or team leadership experience preferred.\n* Experience supporting late-stage clinical or commercial biologics manufacturing preferred.\nRequired Skills\n* Advanced expertise in downstream purification operations and biologics manufacturing.\n* Extensive experience with Protein A and polishing chromatography processes.\n* Strong hands-on experience operating AKTA chromatography systems and TFF platforms.\n* Advanced knowledge of viral filtration, UF/DF, and sterile filtration processes.\n* Strong understanding of GMP regulations, manufacturing systems, and documentation requirements.\n* Proven leadership, decision-making, and organizational skills.\n* Excellent troubleshooting and problem-solving capabilities.\n* Ability to effectively coordinate cross-functional manufacturing activities.\nPreferred Skills\nExperience supporting:\n* Technology Transfers\n* Process Validation and PPQ Campaigns\n* Commercial Manufacturing Operations\n* Regulatory Inspections and Client Audits\n* CAPA and Deviation Management\n* Continuous Improvement and Lean Manufacturing Initiatives\nPhysical Requirements\n* Ability to stand for extended periods.\n* Ability to bend, reach, and lift up to 50 pounds.\n* Ability to work in cleanroom environments while wearing required PPE.","description_format":"text","description_chars":4400,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-11-06T05:02:06Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":3,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 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