Biotechnology focused production, engineering, and management consulting. Our team has 35+ years in globally regulated biologics manufacturing facilities with detailed insight into cell culture, fermentation, filtration, centrifugation, column chromatography, aseptic filling, production support, and process analytical laboratories. Our in depth experience allows 2M to quickly assimilate and deliver results on new products or equipment implementation, process/facility/engineering controls, validation, automation, contamination investigations, and project management. We make problems go away.

• Technical production lead. Led 5 new product introductions and reintroduction for purification operations for both mammalian and microbial products.• Provided day-to-day floor support for campaigns with short duration and quick turnaround times.• Designed the manufacturing business process for monitoring key operating parameters (KOPs) while a process is being transferred into manufacturing from development sites. It addressed “how” manufacturing must implement KOPs into documents and monitoring strategies, and the requirements around that implementation.• Technical writer. Created hundreds of new SOPs and BRs (electronic and paper) for new unit operations.• Led risk assessments, NC investigations, designed and executed CAPAs, and provided technical expertise to resolve process deviations.• Extensive regulatory experience. Have presented to the FDA, EMEA, ANVISA, Health Canada, PMDA, and Turkey. 100% favorability on all presentations.• Unit Operation Expert for UFDF, Column Packing, Viral Filtration, Depth and Membrane Filtration, Chromatography in 50 cm to 2.0 m columns. • Led 2 Global Operations Network teams to standardize column packing processes and implement SoloVPE Slope Spectroscopy for protein concentration measurements on the mfg floor.• Provided on-site support for two products transferred to the Puerto Rico facility.• Provided multi-host support for changeover of mammalian to microbial in shared production areas.• Computer application expert. SharePoint super-user. Wrote multiple databases from managing document errors to tracking resolution for on-the-floor production issues.

• Started as a lab rat, running up to 50 simultaneous BHK roller bottles and 2-20L bioreactors. • Helped launch a clinical manufacturing facility for upstream mammalian processing.• Headed the day-to-day production support for Process Engineering for 3 cell culture suites.• Wrote process descriptions and helped develop the framework for KOP definition. • Process expert for Perfusion bioreactors, cell settlers, UFDF, and filling operations.• Project Manager for an insulin reduction project resulting in an annual cost savings of $6.8M.• Developed automated process monitoring tools in VBA used every day by others in the department. It was the go-to tool for daily support.