Jobs at Miltenyi Biotec

Develop and optimize spatial biology, multiomics sequencing, and in situ sequencing workflows for commercial platforms. Design and analyze experiments, prepare samples and libraries, run sequencing assays, validate performance, develop reagent panels, troubleshoot technical issues, and support technology transfer and commercialization. Collaborate with scientists, engineers, and product teams; document procedures, maintain laboratory operations, present findings, and mentor junior staff while following safety and regulatory requirements.

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.

Field-facing senior specialist responsible for lead generation, qualification, demos, sales forecasting, customer training and support for flow cytometry products. Travels to build accounts, provide onsite installations/support, mentor peers, maintain CRM records, and contribute market/competitive insights to strategy.

Performs downstream process development and purification operations with limited supervision. Prepares buffers and materials, operates chromatography and filtration equipment, executes experiments and analytical assays, maintains documentation, supports process improvements, manufacturing runs, SOPs, BPRs, inventory, and laboratory infrastructure. Collaborates with upstream and analytical teams, contributes to development reports, and trains junior staff. Work involves sanitized laboratory environments, biological materials, and occasional lifting up to 50 pounds.

Manufactures lentiviral biologics under cGMP conditions in a cleanroom. Follows gowning, aseptic processing, SOP, batch record, safety, and documentation procedures. Operates production equipment, cleans work areas, reviews documentation, maintains inventory, and submits purchase order requests. Requires attention to detail, multitasking, rapid work, physical stamina, and the ability to work with laboratory equipment and cultured human cells.

Manufactures lentiviral biologics in cGMP cleanroom conditions. Follows gowning and aseptic procedures, executes batch production records, completes GMP documentation, operates and cleans production equipment, reviews SOPs and batch records, maintains inventory, restocks supplies, and submits purchase order requests. The role requires careful, rapid work in a sanitized laboratory environment with exposure to cultured human cells and lentivirus-derived vector particles.

Drives sales of flow cytometry products through lead generation, funnel management, customer presentations, workshops, product demonstrations, account development, and CRM management. Provides field support, training, troubleshooting, and applications assistance for the MACSQuant install base. Conducts market and competitive analysis, collaborates with technical sales teams, develops customer relationships, and travels domestically and internationally as required.

Supports upstream process development, characterization, qualification, and technology transfer for purified lentiviral vectors used in gene therapy. Performs adherent and suspension mammalian cell culture, transfection, viral vector production, bioreactor operations, media and buffer preparation, and analytical testing. Maintains laboratory equipment, documents data, prepares technical reports, trains team members, and collaborates cross-functionally to support manufacturing transfer and process qualification.

Target and grow territory sales of instruments, reagents, services, and consumables to new and existing life-science accounts. Perform demos, troubleshooting, trade-show representation, and customer relationship management. Track opportunities and reports in CRM, execute territory growth plans, provide market/competitive feedback, and collaborate on strategic initiatives. Role requires frequent travel, physical handling of equipment, and adherence to safety/SOPs.

Lead SAP analytical, build, test, and deployment efforts; design operational cockpits, predictive alerts, and reprocessing; gather requirements and configure SAP for process improvements; manage integrations and testing (unit/system); document changes; collaborate with IT PMs; and train users on applications and QA processes.

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.

Drive sales for flow cytometry products via lead generation, demos, and account management. Provide onsite training and post-sale support for MACSQuant, use CRM to track opportunities, participate in market analysis, attend trade shows, and travel domestically and internationally to build customer relationships.

Lead site Quality Control for biologics, managing QC team and processes including method implementation, transfer and validation, sampling, stability, comparability, specification setting, and lot release testing. Ensure GMP compliance and QMS governance, support manufacturing investigations, drive quality metrics and continuous improvement, and collaborate with global QC to harmonize processes.

Lead and develop a North America trade compliance and logistics team, build and implement trade programs, manage customs relationships and 3PLs, ensure HTS/ECCN classification accuracy, oversee import/export operations and audits, train staff, drive logistics strategy and operational KPIs, and advise leadership on regulatory and sanction changes to mitigate supply chain risk.

The Manager of Cost Accounting leads a team, oversees accounting activities, manages month-end close, supports audits, performs variance analysis, and drives cost reduction initiatives.

This role leads strategic marketing initiatives for regulated products, focusing on brand awareness, demand generation, and revenue growth across North America. Responsibilities include collaboration with sales teams, market trend analysis, budget management, and fostering a high-performance culture in product marketing.

Lead global product and portfolio marketing for life-science products in North America. Develop go-to-market strategies, pricing, launches, forecasts, and sales enablement; manage cross-functional teams and key account relationships. Drive revenue targets, perform market research, and support field activities with up to 40% domestic travel.

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.