CMC lead for commercialization of products from early to late stage with global experience

Lead the chain of identity & chain of custody team in CGT supply chain and also have a lead role in defining the commercialization strategy for supply chain and the supporting IT ecosystem.

Responsible for all technical aspects of a commercial global biopharmaceutical product in the manufacturing organization. * Develop and maintain product and microbial control strategy* Perform continued verification of process performance* Resolve product complaints as they relate to quality or technical issues* Proactively identify product technical risks and define action plans* Review progress and impact of significant investigations* Manage process knowledge for the life of the product* Ensure process safety* Make process improvements* Work with R&D team to commercialize product lifecycle changes * Review and act on trends* Review technical changes across the value stream

Lead commercial CMC team. Partner with operational functional managers (Manufacturing, Development, QA/QC, Supply Chain, Regulatory, Finance, Accounting, Global Project Management, and Commercial Operations) to develop, execute, and monitor plans for ongoing manufacturing, continuity of supply, and life-cycle changes. Indirect management of over 15 individuals. Lead joint manufacturing committee with partner GlaxoSmithKline (GSK) to achieve alignment on all operational activities and budget. Responsible for updating and adhering to partnership contracts.Manage product supply and participate in the S&OP process with sales, forecasting, finance, marketing, and accounting. Responsible for short-term and long-term supply planning to ensure inventory levels are maintained within desired ranges, life-cycle changes are strategically integrated, capacity is available to meet demand, and supply continuity is maintained by pursuing secondary sites or other contingencies where appropriate.Lead the supply chain risk evaluation and management team for Benlysta®. License to launch project manager for Benlysta®. Planned and integrated all activities within HGS and with outside contractors. Executed plan in 8 days and 19 hours.

BDS CMC leader for Benlysta® indirectly managing over 7 individuals:Lead multifunctional team which provides technical oversight to all CMC activities supporting US and x-US regulatory applications and licensure. Ensure project activities and goals are executed and clearly communicated across the organization. Represent the CMC team at core team within HGS. Also represent CMC team with strategic partner, GSK.Author and reviewer of regulatory submissions including Benlysta® BLA. Represented HGS during US and EU pre-approval inspections of BDS manufacturing facility. Involved in resource planning and budget process.Team lead for Benlysta® cell culture process supervising up to five individuals:Responsible for process validation, production support, technical transfers, development of second generation process, pasteurization implementation, assay qualifications, and identification and qualification of secondary raw material suppliers.Lead technical transfer of the upstream commercial BDS process to Lonza, Portsmouth.Development lead for implementing pasteurization into the commercial manufacturing process.Highlights Include:Responsible for initiating and overseeing new impeller design for 20,000-L production bioreactors using computational fluid dynamics. Increased the production of a monoclonal antibody in the facility by over 35%.Oversaw development of second generation process capable of achieving a 91% increase in productivity over first generation process by implementing media and process changes. Team lead for technical transfer of late stage CMO yeast process to HGS’s 750-L microbial facility. Wrote Corporate NSO Upstream Platform Process Technical Report

Team lead for Benlysta® cell culture process directly supervising up to four individuals:Led successful upstream technical transfer into new 20,000-L bioreactor manufacturing facility. Responsible for media, cell culture, and recovery engineering studies in preparation for process transfer. Noticed scaling issue after first engineering run and implemented process changes within characterized design space to fix issue for first GMP Run. Developed technique for scaling PID values of pH and DO loops. No tuning of PID loops needed for engineering or GMP runs in all reactors in the brand new 20,000-L facility.Led validation and characterization studies. Editor and reviewer for U.S. and EU regulatory submissions. Team member for insourcing opportunities.