Jobs at Lonza

Provides scientific and technical leadership for purification processes in pharmaceutical drug substance manufacturing. Responsibilities include process optimization, troubleshooting, technology transfer, validation, regulatory submissions, inspections, quality investigations, cGMP compliance, process monitoring, and continuous improvement. The role leads complex projects, makes cross-functional technical decisions, supports commercial products, and mentors junior team members.

Performs basic to moderately complex analytical testing for pharmaceutical materials, drug substances, drug products, raw materials, and stability lots. Supports cGMP laboratory operations, troubleshooting, method transfers, deviations, change records, reagent preparation, inventory management, data integrity, and continuous improvement initiatives.

Partners with the Site Head to guide daily operations and strategic direction. Leads tactical and strategic projects affecting site productivity and profitability, manages PMO activities, monitors operational and financial KPIs, supports organizational transformation, and develops communication strategies to drive engagement. Requires strong leadership, change management, project management, analytical, organizational, and interpersonal skills, along with proficiency in Microsoft Office and data analysis tools.

Provides global leadership for sterility assurance and contamination control across sterile pharmaceutical and biologics manufacturing sites. Develops contamination control strategies, leads risk assessments and investigations, oversees CAPAs, standardizes network procedures, supports product introductions and facility start-ups, trains employees, and contributes to regulatory inspections, audits, and inspection readiness.

Coordinates global operational QA/QC governance, harmonizes quality standards and processes, oversees CAPA and quality-risk escalation, and drives inspection readiness across sites. Leads global quality plans, training frameworks, change management, quality culture initiatives, and continuous improvement. Requires extensive GMP-regulated experience, expertise in QMS, LIMS, validation, product release, data integrity, and regulatory expectations, plus strong stakeholder-management and analytical capabilities. Travel is required up to 10%.

Administer global learning activities in Cornerstone, including training assignments, curricula, learning items, user records, reporting, compliance monitoring, and audit readiness. Provide first-line LMS support, troubleshoot issues, test system releases, and coordinate with global and local training owners. Upload and validate eLearning content, maintain data quality, support GMP and ERES compliance, and drive consistency across global learning systems.

Conduct analytical testing and protein characterization studies using mass spectrometry, chromatography, electrophoresis, and related methods. Analyze and interpret data, support reference standard qualification, forced degradation, product characterization, and biocompatibility studies under ICH and cGMP guidelines. Review GMP documentation, maintain laboratory equipment and inventory, troubleshoot issues, support safety and training programs, and contribute to automation and operational improvements.

Support process transfer and manufacturing by developing process understanding, performing gap analysis/FMEA, authoring/reviewing process documentation and change controls, executing complex data analyses, assessing deviations, conducting root cause analysis, supporting regulatory documentation and audits, and mentoring junior staff within cGMP commercial manufacturing.

Manages analytical instrumentation supporting QC, MSAT, and manufacturing. Coordinates preventive maintenance, calibration, repairs, vendor services, procurement, CMMS records, equipment lifecycle activities, and maintenance KPIs. Ensures GMP compliance, data integrity, qualification assessments, change controls, deviations, CAPAs, audit readiness, and regulatory inspection support while improving equipment reliability and minimizing downtime.

Supports GMP mammalian manufacturing operations through cleaning validation for large-scale stainless-steel bioreactors, media, buffer, and product pool tanks. Prepares, reviews, optimizes, and controls assigned tasks using a Right First-Time mindset. Provides field and administrative support to manufacturing staff and helps collect information for deviations, change requests, CAPAs, and investigations related to cleaning activities.

Provide process expertise for bioconjugate API manufacturing: support technology transfer, troubleshoot production, drive process optimization, prepare CPV/APQR, implement continuous improvements, and act as technical SME across cross-functional teams.

Lead customer complaint investigations, root cause analyses, corrective actions, quality audits, and GMP compliance initiatives. Analyze quality metrics, customer feedback, process capability, and VOC trends to drive continuous improvement. Establish quality controls, support manufacturing issue resolution, assess quality-system risks, and communicate recommendations to customers and cross-functional teams. The role requires strong quality engineering expertise, statistical improvement methods, customer engagement, and regulatory compliance experience in a manufacturing environment.

Leads Quality Control activities for customer programs in a GMP-regulated biologics environment. Coordinates analytical deliverables, manufacturing schedules, project milestones, risks, deviations, investigations, CAPAs, and change controls. Serves as the primary QC customer interface and collaborates with laboratories, QA, Production, MSAT, and project teams. Represents QC in customer meetings, audits, and inspections while balancing compliance, quality, costs, timelines, and customer expectations. Drives issue resolution, communication, and continuous improvement.

The role involves financial controlling and business partnering, focusing on cost analysis, budgeting, variance investigation, and process improvements.

Lead technical sales strategy for bioprocessing and gene therapy solutions. Support complex sales opportunities through technical consultations, workshops, demonstrations, troubleshooting, and proof-of-concept projects. Build strategic customer relationships, train and coach commercial teams, and collaborate with Product Management, R&D, Marketing, Quality, Service, and Regulatory Affairs. Translate customer, market, and competitive insights into recommendations for portfolio innovation and growth while ensuring compliant, scalable solutions in GMP-regulated environments.

Configure and support LabVantage LIMS including interfaces, instrument integrations, and reporting. Guide validation for GxP and CSV, maintain SOPs and documentation, troubleshoot enhancements, and apply ITIL practices to manage incidents and service availability.

Support delivery of strategic capital projects across the ADS platform: develop project charters, scopes, schedules, and business cases; lead technical evaluations and process engineering activities; coordinate cross-functional teams to ensure GMP-compliant design, start-up, and operational readiness while managing risk, change, cost, schedule, and stakeholders.

Support GMP manufacturing by reviewing batch records, quality events (deviations, CAPAs, change controls), and quality documentation. Provide QA oversight on the floor, contribute to KPI reporting, and collaborate with manufacturing and cross-functional teams to ensure compliance and continuous improvement.

Lead cost controlling and SAR activities, ensuring governance and insightful analysis to support strategic decisions. Develop a team of cost controllers and drive automation initiatives.

Lead the Bend site's Quality Assurance Management System and quality programs, ensuring regulatory and corporate compliance. Oversee investigations, change controls, CAPAs, audits, inspection readiness, risk-based strategies, and continuous improvement. Serve as the primary site quality contact while partnering with clients and cross-functional stakeholders. Lead, coach, and develop the Quality Assurance team and support compliant pharmaceutical manufacturing operations.