Todd Ebner Email & Phone Number

California, United States

New York, New York, Us

Gaithersburg, Maryland, Us

□ Process validation owning pFMEA Risk Assessments for classification of process inputs and outputs for Process Control Strategies for Drug Substance Life Cycle Management, Stages 1-3 per PDA Tech Report TR-60 and ICH guidelines□ Responsible for contract manufacturing site Process Validation Master Plans, Process Performance Qualification (PPQ) protocols, summary reports and supporting documents such as CPV, resin lifetime, and other risk assessments necessary for validation of the DS process □ Ownership of Manufacturing 3.2.S.2 and other CTD sections for regulatory submissions (BLA, EMA, ROW)- author of S.2.1, S.2.3, S.6 and support of other sections □ Responsible for Request-For-Information, Health Authority Commitments and responses from agencies. Owned resin lifetime protocols/reports for each CMO, impurity removal studies, and in-process testing support and for regulatory commitments□ Wrote risk assessment justifying re-use of high-cost materials with cost savings of >$3 million per year□ Provide validation assessments for change controls for validation impact□ MSAT owner of Raw Material Risk assessment and classification of raw materials at multiple CMOs for commercial process

Basel, Ch

□ Technical mRNA purification SME on GMP and Quality activities on the production floor for a 24/7 mRNA single-use facility, producing one IVT mRNA batch every week in up to six production suites in clinical and commercial batches concurrently □ Evaluate and lead column chromatography purification process improvements to optimize the purification process I.E. In-house column packing, method evaluation, chromatography system error reduction□ Monitor and trend process parameters in DeltaV software. Ensure production is stable and leads troubleshooting evaluation with management and client. Ensure for timely release of batches with QA □ Mentor new hires on chromatography systems at Lonza and production operators on best practices and troubleshooting□ Initiate and complete Change Controls, Deviations, and CAPAs for continuous process improvement. Evaluate technical documents (PPL, Diagrams, FMEA) with client for production, including scaling up of existing process to increase production by 25%□ MES/eBR production support for first time in mRNA process□ Lead cross functional team as project owner for 10MM project of packing Axichrom columns□ Lead Platform Process Implementation for Chromatography Operations across 3 scales (60L, 75L, 100L IVT reaction) with gap analysis within timelines for strain variants directly to PPQ □ Team deputy for team of multiple engineers

Tustin, California, Us

□ Technical protein purification SME on GMP and Quality activities on the production floor□ Collaborate with Quality, Manufacturing, Process Development, and Client to lead tech transfer new processes into manufacturing and scale up existing processes□ Provide technical support with regard to GMP manufacturing, including troubleshooting and problem solving on the manufacturing floor (Chromatography, Filtrations, TFF, Bulk Filling Operations)□ Yield tracking and data trending for continuous process verification for commercial products and process performance qualifications- established a CPV model for a PPQ product with client to evaluate Quality Attributes and CPPs□ Write investigations, deviations, and assist in CAPAs to drive continuous improvement. Provide product quality evaluations after incidents occur. Lead a cross functional high level investigation with executive team involving multiple commercial batches to support incident closure with multiple experiments and collaborations with external vendors□ Write protocols to support manufacturing processes, perform scale down purification verification runs. Completed viral clearance study to support a phase 1 molecule□ Provide updates to senior management, project management, and clients regarding the purification process to bulk product. Provide technical quality review of the batch production records and UNICORN methods □ SME for 6 proteins, including 2 commercial products, and SME for 2 PPQ molecules□ MSAT lead for two phase 1 molecules successfully transferred into manufacturing (200L and 1000L scale) and secondary engineer on 2 other phase 1 molecules from PD to manufacturing, including BOM generation and raw material evaluation□ Process improvements implemented for AKTA Ready flow kit re-use and standard of troubleshooting pre-packed columns.□ Liaison with vendors to evaluate new technologies to improve the processes

□ Support 24/7 commercial manufacturing of plasma derived therapies- SME on Factor VIII□ Support manufacturing with continuous process improvement (yield, cycle time, validation projects)□ Provide technical support with regard to GMP manufacturing, including troubleshooting and problem solving□ Yield tracking and data trending using systems such as Discoverant, OSIpi, and other software to monitor process steps from DeltaV, EBM, and LIMS□ Evaluation and preparation of planned process changes within Change Control Systems □ Support and test new technologies in pilot lab and assist with scale down DoE studies of commercial process to evaluate process improvements using AKTA Avant and BCS XP activity assays□ EHS representative for department in Pilot Lab

Duarte, Ca, Us

□ Purification Process Development of novel proteins at lab scale; Affinity, SEC, IEX, HIC, and IMAC using various resins and columns to purify Monoclonal Antibodies (Diabodies, Fragments, Mutations, Bispecifics etc) under direction of Principal Investigator □ HPLC, SDS-Page, IEF, Western Blot, Nanodrop, ELISA, and UV-Vis analytical techniques of protein characterization after purification □ Consult scientific literature for optimization of protein purification□ Bio-Rad NGC Chromlab software for FPLC and GE AKTA Purifier UNICORN for purification at bench scale□ Revise, initiate, execute Batch Production Records and SOPs for in-house scale up for clinical GMP runs □ Develop timelines for GMP runs and ordering of raw materials□ Concentration and Diafiltration of Proteins, and aseptic technique for vialing of product in GMP for 2 phase one molecules at in-house GMP facility□ Conjugation of proteins for antibody imaging, ADC attachment, and analytical development of the molecule □ Assisted with purification CMC section for IND submission for Phase 1 molecule□ Lab scale TFF development with cassettes and hollow fiber filters, as well as GMP□ Assist with cell culture sampling, cell counts, and harvest from Wave/ Autovax bioreactors□ GMP Stability testing for in-house manufactured molecules□ Coordinate with QA and vendors to plan out GMP batches for clinical production□ Contributed to 3 manuscripts that were accepted for publication

Tustin, California, Us

□ Commercial and clinical purification of enzymes and antibodies for 7 molecules in GMP compliance as manufacturing SME on the floor□ Revise, initiate and execute Batch Production Records, SOPs, and study protocols□ Purification of proteins via Affinity, SEC, AEX, HIC and TFF. Manual and automated processes □ Product filtration using sterile filtration, ultrafiltration, and viral filtration (Viresolve, Virosart etc) □ Aseptic technique when sampling product and Final BDS in laminar flow hood□ Pack, unpack, and clean chromatography columns at various scales (OCS, BPG, AxiChrome) □ GE Akta Ready chromatography Single-Use skid operations with Unicorn□ Pall Allegro Single-Use TFF with Wonderware programming □ Mentor and train junior staff on all purification operations and GDP documentation□ Used tech transfers to assist writing BPRs, while working closely with other departments □ Report on critical processing parameters with MSAT for Process Validation runs □ Coordinating schedules with multiple departments to improve process flow□ Writing of Incidence Reports and assistance with CAPAs□ Participated in validation and engineering runs of first production in new GMP Single-Use Facility Run purification process during regulatory and client audits (FDA, EMA etc) □ Works with vendors and supply chain to order product/ client specific equipment □ Liaison with clients and handles customer requests and changes□ Helps streamline processes to create better and more efficient process flow, including Kan Ban and 5S

Waltham, Massachusetts, Us

□ Buffer and media production, equipment calibration, titration of buffers for pilot Preclinical and clinical runs in mammalian cell cultures while executing batch records. (IgGs, IgM, Interleukins, Fusion proteins) at scales ranging from 50L to 2000L (8 different molecules in total) at a CDMO facility□Worked on Pilot runs, GMP (3 LPM, 10LPM and 30LPM process skids) and AKTA pilot purification skids during production using UNICORN system□ Responsible for setup, operation and troubleshooting of small, mid, and large-scale bioprocessing operations i.e. column operation, column packing, calibration, TFF, filtration, depth filtration, viral filtration, etc□ Experience with different types of chromatography such as Bind and Elute and flow-through columns (Affinity, SEC, AEX, HIC, CHT resins)□ Viral reduction steps using nanofiltration, viral holds, and UVC irradiation (UVivatec), CIP and SIP of equipment associated with protein production (Skids, Uniflux, TFF holders)□ Worked closely with process development groups to ensure technology transfers run seamlessly. Assisted with writing SOPs, Master Batch Records, DCR’s, deviations, validation of equipment□ Managed timelines for preparation of purification runs, procuring raw materials, process solutions/buffers and equipment available and ready to use□ Handled client requests and liaison during process□ Bulk fills inside Biological Safety Cabinets of Bulk Drug Substance

St. Louis, Mo, Us

□ Environmental monitoring, plate reading, and trending of data in a FDA/ EU regulated CDMO □ Facility steam/water testing and sampling for TOC, Endotoxin, bioburden, and conductivity □ Gram staining, sub-culturing and microbial identification using Vitek2 in a GMP laboratory □ Biological safety cabinet work while performing aseptic testing

San Antonio, Tx, Us

□ Gowning and aseptic technique for set up and during product fills ISO 6 and participated in media fills for four different lines of operation□ Product transfers and manufacturing equipment operation for multiple products□ Autoclaving, terminal sterilization, and checking/ recording batch records□ Developed and executed procedural controls for the operation and maintenance within a sterile environment in an FDA and EMA commercially regulated company with multiple different products (CMO)

Seattle, Wa, Us

Worked at 3 different locations in the Costco Food Court and front end during summer breaks and during the semesters in college.