Jobs at Miltenyi Biotec

Provides QA oversight for cGMP manufacturing of cell and gene therapy products. Reviews batch records and testing data, dispositions materials and products, supports investigations, deviations, CAPAs, change controls, audits, validation, inspections, and product release. Performs shop-floor QA activities, writes and approves GxP documents, trains cross-functional teams, and ensures compliance with FDA, EMA, ICH, ISO, and company quality systems.

Leads analytical method transfers for cellular therapy products into Process Sciences, serving as a liaison between Process Sciences and Quality Control. Supports stability programs, R&D, GMP documentation, protocols, reports, investigations, CAPA, risk assessments, and continuous improvement projects. Mentors junior staff and troubleshoots analytical issues. Requires expertise in immunoassays, flow cytometry, ELISA, qPCR, advanced analytical methods, cGMP regulations, validation, qualification, transfer, and statistical analysis. Travel is 10–20% domestically and internationally.

Performs environmental, process, sterility, and microbiological testing in a GMP quality control laboratory. Initiates deviations and OOS investigations, conducts method validation and assay development, trends environmental and personnel monitoring data, supports equipment calibration and sample management, and coordinates testing schedules and contract laboratory activities. Contributes to laboratory improvements, regulatory compliance, documentation, audits, and continuous improvement initiatives for cellular therapy and drug products.

Lead QA for the San Jose CDMO site, overseeing Quality Operations, QMS, CMC quality, inspections, audits, batch release, supplier quality, technical transfers and regulatory submissions. Build and develop a high-performing QA team, ensure inspection readiness, drive compliance with international GxP and pharmacopeial standards, and support client commercialization programs and global quality initiatives.

Provide MSAT support for biologics/gene therapy manufacturing: lead technology transfers, author and implement GMP documentation, troubleshoot process deviations, manage CAPAs/change controls, support process validation, analyze process data, and collaborate with QA/QC/Validation and external stakeholders to ensure compliant, scalable manufacturing operations.

Provide MSAT technical support for biologics/gene therapy manufacturing including tech transfer, GMP documentation (SOPs, BPRs), troubleshooting, investigations (deviations, CAPAs), process validation/qualification, trend analysis, and cross-functional collaboration to ensure compliant, scalable production.

Manage client and internal cell and gene therapy projects across process and analytical development, tech transfer, and GMP manufacturing. Lead full project lifecycle, control scope, schedule, budget, risks, contracts, and stakeholder communications to ensure compliant, on-time delivery.