Program Manager and subject matter expert for a late-stage monoclonal antibody bulk drug substance in-production at multiple CDMOs to support global regulatory EUA/CMA and BLA submissions.- Tech transfer to CDMO and process alignment- Issue investigation and resolution- CDMO deviation review and approval- Technical Batch Record Review

Biotechnology focused production, engineering, and management consulting. Our team has 35+ years in globally regulated biologics manufacturing facilities with detailed insight into cell culture, plant botanicals / nutraceuticals, fermentation, filtration, centrifugation, column chromatography, aseptic technique, production support, and process analytical laboratories. Our depth in experience allows 2M to quickly assimilate and deliver results on new products or equipment implementation, process/facility/engineering controls, validation, automation, microbe and virus contamination investigations, and project management. We also have experience developing virus mitigation or microbe contamination mitigation programs that involve development and implementation of engineering, procedural, and facility design controls. We also offer product formulation and commercialization services. We make problems go away.

Investigate and author major deviations associated with upstream and downstream biologics production. Issue resolution; develop and implement CAPAs.

Senior Production Specialist at the LakeCentre multi-host clinical and commercial manufacturing facility, implementing four new product introductions. Process and document owner for centrifuge, filtration, buffer preparation, chromatography, UF/DF, and on-line HPLC analytical equipment. -Cross-functional leader of the Multi-host and Changeover program. A first in industry program approved by the FDA. Successfully completed the implementation, dramatically improved organization's execution of program requirements, and went onto to improve overall efficiency. A single improvement I was responsible for yielded a savings of $240K in labor, $160K in spare parts, and 25 days schedule reduction ($9.7M plant capacity savings).-Experienced in development and implementation of continuous improvement projects, root cause and fault tree analysis, leading and authoring FMEA/risk assessments, authoring regulatory filings, CBE-30 question responses, and achieving FDA approval.- Non-conformance and CAPA owner.- Experienced owner and implementer of major changes via project management and formal change control.My most recent work included: -Implementation of a new 1.6 meter column chromatography system coupled with an on-line HPLC. Amgen's first commercial Process Analytical Technology for high purity chromatography collection. -Initiation and implementation of major changes to Purification and Buffer Preparation processes, equipment, automation, and staff practices to reduce contamination events and bioburden with proven results. Utilizing lean principles, KT analysis, and leading the implementation of a portfolio of projects reduced purification product pool contamination events from 19% to 0%.-Project Manager for LakeCentre production facility restart team. Developed a detailed business plan, project schedule, and budget for hypothetical restart dependent on successful trebananib clinical trial outcome or third party purchase of LakeCentre.

Cell Culture business process owner and technical oversight role, including project management of large manufacturing projects and corporate initiatives. -Managed industrial engineering and plant scheduling staff.-Led team to perform a manufacturing capacity analysis and produce a manufacturing process model driving improvements in manufacturing floor task performance consistency and schedule optimization.-Developed and implemented a project prioritization tool to communicate and effectively coordinate cross-functional resources.-Led a Cell Culture New Product Introduction. Led the process owner team responsible for technical oversight, engineering support, manufacturing schedule development, controlled document writing, validation, manufacturing training, hypercare support and production issue resolution. Coordinated the 100% success of all cleaning and process validation sampling.-Owner and project manager of complex non-conformance investigations and CAPA records.- Led manufacturing implementation and training of major CMMS Maximo upgrade incorporating handheld technology into work functions.- SME for development of Six Sigma Long Range Plan. Provided statistical modeling support and engineering support for prioritization and execution of a portfolio of equipment and process optimization projects.- Led internally driven continuous improvement and FDA observation corrective action projects. Utilizing lean principles and an A3 process I implemented significant improvements to manufacturing validation execution. Overhauled cleaning validation equipment release process improving success rate to 95%. Improved QC sample submission process by defining special preparations and handling requirements, reducing sample submission errors by 50%.

Supervision of commercial biologics manufacturing. Areas of responsibility included production support, cell culture, and purification. Competency in leading teams, leading complex investigations including microbial and viral contaminations, troubleshooting complex equipment, task execution and macro-schedule management, validation planning and execution, defining process and engineering requirements, non-conformance/deviations, batch record review.

Cell Culture operations including bioreactors, aseptic filling machine, ultrafiltration, media and buffer prep. My off the floor roles during this time included: Process Monitoring, System Owner of Production Equipment, ERP, Scheduling, Contractor Management, Batch Record Review, Shift Supervisor.

Technical support manager for dial-up internet service provider. Assembled computer hardware and installed computer networks for small businesses.