Charles Rieger Email & Phone Number

West Sacramento, CA, US

Sacramento, California, United States

Redwood City, California, United States

• 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.
• 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.
• 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

Lodi, California, United States

• 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

Vacaville, California, United States

• 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.
• 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

Vacaville, California, United States

• 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.

Vacaville, California, United States

• 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

Fremont, California, United States

• 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