Senior Biologics Manufacturing Technical Expert
$146.54k - $189.64kScorpion Therapeutics
Job Description Lead design, startup, and operation of a new Single-Use DS biologics drug substance (cGMP) manufacturing facility in Foster City, CA (hybrid technical/execution role with on-floor presence). Execute and document unit operations; perform dry/engineering runs and end-to-end walkthroughs to ensure first-time execution readiness. Act as technical first responder during campaigns; plan/execute full‑scale process and equipment validation. Provide manufacturing end‑user input to facility/equipment/automation; support digital manufacturing/data workflow startup. Participate in risk assessments; translate new process requirements into equipment/automation/documentation updates. Improve processes to increase yield, capacity, efficiency, compliance, and safety; compliantly apply AI/digital tools to boost productivity. Author/review SOPs, work instructions, batch records, validation protocols/reports; initiate/support CAPAs for deviations; support QRM and health authority interactions as SME. Basic Qualifications Recognized expert in Biologics Drug Substance Single-Use Manufacturing. BS in Science or Engineering + 6+ years technical experience in Biologics DS Manufacturing. Additional Technical Experience (3+ areas) On‑the‑floor SU technologies experience; SUT engineering/trending. cGMP facility/utility/equipment commissioning, qualification, validation, operational startup. Risk‑based cGMP controls (incl. Contamination Control Strategy). CHO DS process development/validation/tech transfer. Process automation/MES/ERP recipe design and use (examples preferred: Emerson DeltaV, PI, Ignition, Korber PAS‑X, SAP). Digital manufacturing lifecycle/parameterization/tech transfer; practical AI/digital solutions. cGMP QA, QRM, plant floor oversight/auditor experience; manufacturing optimization/continuous improvement. Health authority/inspection knowledge (FDA/EMA/ICH); people leadership/management. Compensation & Benefits Salary range: $146,540.00–$189,640.00. May include discretionary bonus, long‑term incentives, paid time off, and company‑sponsored medical/dental/vision/life. Application Instructions For current employees/contractors: apply via the Internal Career Opportunities portal in Workday. #J-18808-Ljbffr Scorpion Therapeutics
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