Jobs at Miltenyi Biotec

Leads global quality assurance, audit, supplier quality, inspection readiness, and compliance programs for biologics manufacturing and outsourced GxP operations. Oversees audits, supplier qualification, quality agreements, risk management, corrective actions, regulatory inspections, SOPs, and approved supplier list maintenance. Manages and develops audit and supplier quality teams while driving cross-functional improvement initiatives and supporting regulatory submissions.

Leads regulatory CMC strategy and execution for cell and gene therapy programs across global regions. Oversees CMC content for INDs, CTAs, BLAs, and MAAs; supports health authority interactions, process changes, comparability, validation, change control, risk mitigation, and post-approval lifecycle management. Partners with development, manufacturing, regulatory operations, and external consultants to deliver submission-ready documentation and support clinical development, marketing authorization, and commercial launch activities.

Leads global CMC Regulatory Affairs strategy for a Cell and Gene Therapy portfolio across development, registration, commercialization, and lifecycle management. Oversees regulatory submissions, manufacturing change assessments, process and analytical strategies, health authority interactions, risk mitigation, and compliance with global requirements. Manages and mentors CMC Regulatory Affairs leaders while collaborating with process development, manufacturing, quality, supply chain, and clinical development teams.

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.

Prepares and reviews federal, state, local, and foreign tax returns, filings, reconciliations, and ASC 740 tax provisions. Conducts tax research, responds to notices, supports audits and tax projects, and assists with tax planning. Coordinates with tax jurisdictions and agencies, resolves tax issues, and trains staff accountants on tax processes and projects.

Leads the Quality Management System and GxP compliance operations across biotechnology and pharmaceutical functions. Manages quality systems, eQMS and LMS platforms, document control, deviations, CAPA, change control, audits, vendor quality agreements, inspections, investigations, SOPs, and regulatory compliance. Oversees Quality Assurance teams, supports inspection readiness, partners cross-functionally, and drives continuous improvement, risk management, and a strong quality culture.

Supports IT, Data, and Business teams on AI-related initiatives in an enterprise manufacturing and life sciences environment. Responsibilities include testing AI tools, documenting and organizing automation workflows, preparing and cleaning data, maintaining AI system documentation, troubleshooting and monitoring AI-driven tools, and helping integrate AI solutions into business processes. This is a full-time onsite internship in Gaithersburg, Maryland, scheduled from September 2026 through March 2027.

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.

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.

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.

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.

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.