• Provide Quality oversight of Contract Manufacturing Organization (CMO) in support of Drug Substance operations to ensure Quality issues, both internally and at the CMO, are thoroughly investigated with appropriate actions• Support the disposition of Coherus commercial products through review and approval of cGMP documentation, master batch records, executed production records, certificates of analyses, certificates of testing, and quality systems records• Provide person in plant oversight at CMO• Escalate product quality issues to upper management and the Product Quality Review Board (PQRB) • Manage deviations and change controls for Coherus and CMOs to support release of commercial products• Perform disposition of Drug Substance (DS) commercial batches, which includes review of executed batch records, deviations and change controls to ensure the product is acceptable for release for further processing

Assisted in hiring the Quality Assurance department, including 2 additional supervisors,and 16 QA associates • Leads Daily Management Meetings • Responsible for prioritization of daily QA activities to ensure compliant batch recordreview and product release • Train and supervise QA personnel to support batch record release activities • Providesprofessional and personal development opportunities to subordinates, through managingPP&R and 1:1 meetings • Manage conflict resolution and negotiation • Address deficiencies and ensure resolution to all batch records according to GMPstandards • Quickly and effectively resolve issues through positive interactions withstakeholders • Develop and maintain QA metrics to track batch record and documentreview capabilities and workflow. • Maintain and report out Daily Management KPI and release metrics • Identify areas of concern related to batch record and documentation compliance ororganizational compliance • Regularly report organizational activities to management. Identify areas of concernrelated to batch record and document compliance or organizational compliance •Facilitate process improvements within department that support the Quality System,while trying to implement Lean Manufacturing

Provide quality oversight of manufacturing operations (CCP1/CCP2), facilities, utilities, and Quality Control. Solve a variety of routine to moderately complex issues, following cGMP regulations and standards by applying basic theory and technical principals.• Identify and recommend solutions to potential procedures, process and system gaps• Provide assistance/oversight to internal and external customers in support of departmental functions• Collaborate with manufacturing and SMEs (Manufacturing Frontline, Automation, PPIM, etc) to triage deviations to the manufacturing process and ensure minimal impact to the process and/or product quality • Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership • Serve as a technical subject matter expert (SME) in support of department functions• Draft, review and approve SOPs, Change Records, Protocols and Technical Reports. • Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product• Provide assessment and approval for controlled document changes• Lead/assist with discrepancy investigations as well as interact with interdepartmental contacts on discrepancy assessment, resolution and Quality approval• Assist with manufacturing facility and equipment start-up/changeover/tooling activities• Perform Batch record review of paper tickets and batch exceptions in electronic batch records• Genealogy and lot trace of all batch records• Participate in audit and inspection preparation activities• Member of Batch Record Review (BRR) team. Collaborate with representatives from all shifts to ensure alignment within MQA • Assisted manufacturing in startup activities• Perform routine Gemba walks with operations to maintain process knowledge, collaborate with manufacturing to identify compliance risks and opportunities for continuous process improvement

• Day shift lead for CCM Operations• Ensure adherence to schedule and addressed processing issues• Member of dO2 maintenance team, training team, FIT/5S team, inspection readiness team, and safety team• Working knowledge of all Cell Culture operations: Seed Train, Inoculation Train, Production Train, Harvest, Small Volume/Large Scale Media Preparation• Created standardized 5S program after department merger• Project Manager for new startup Seed Lab o Point of contact, working with vendors, contractors, and finance, on designing and developing new startup Seed Lab o Responsible for ordering new equipment, creating and writing new SOPs

• Downstream Purification manufacturing operations• Executed Purification operations through strict adherence to SOPs according to cGMP regulations• Coordinated with Facilities, Quality, and Technology groups to address significant manufacturing deviations and facilitate remediation• Member of training team, safety team, pH probe rebuilding team, column packing team• Participated in startup activities for new CCP2 Manufacturing facility • Performed debug and engineering runs for startup• Completed weekly cycle counts as member of POG cycle count team in support of SAP implementation• Implemented multiple process improvements to drive cost savings and continuous improvement

• Team Lead for automotive manufacturing trim department responsible for the installation of manufactured airbags into automobile dashboards• Interact with automated manufacturing systems to ensure seamless production is maintained• Use technical background to troubleshoot problems that arise in manufacturing process to ensure minimal impact to the production schedule• Utilized communication skills to efficiently and effectively convey necessary information to oncoming shift• Studied fundamentals of the Toyota Production System • Attended Toyota Manufacturing Leadership classes• Participated in Kaizen projects that helped with ergonomics, time and cost savings• Experienced in Lean/5S and Kanban