-Align Supply Chain initiatives against commercial strategy.-Portfolio management across US and EU sites ensuring new product readiness, BoM adherence to platform for expedited delivery. -Technical procurement support, RFP, RFI, vendor relationship-Leverage technical expertise in cell and gene therapy, plasmid manufacturing, biologics, to interpret trends for supply chain inventory strategy.

Led Operations, Technical Leads and Manufacturing Compliance team. Organization included 20 scientists and engineers.

Viral Vector Services CDMOSite Leadership Team Viral vector development, characterization and manufactureLenti / AAVSuspension and Adherent platform

Viral Vector Services CDMOgene therapy manufacturing of viral vectors, M/WCB M/WBIIC, Final fill operationsProcess Development / Characterization Adherent / Suspension platformsLenti / AAV Quality / Regulatory support Smartsheet, MS project, SAP, SalesForce

Biologics CDMOCell culture monoclonal antibodiesFermentation Recovery operations Pre clinical development and commercial support

Lead multiple Upstream projects Manage laboratory operations and ScientistsWork cross functionally to ensure successful project transfers Lead Upstream FMEA for transfer projectsSupport sales department in proposal writing and timeline creation

Focus in process engineering including FMEA, Gap Assessment, Facility Fit, Scale-up, formulation record approval and raw material item specifications.Technical Lead for process development studies for Pichia pastoris process including shake flask, fermentation, and recovery unit operations. Design experiments to mitigate risks moving forward to manufacturing. Write proposal with timeline, hours, FTE needed for project. Transfer process into cGMP manufacturing by participating in training technicians, reviewing batch records, escorting onsite clients, and helping with critical process steps.Manage third party contracts for WCB/MCB testing including proposals, scheduled meetings and data review.Member of site wide Coaching Committee

Certifications:Lean Six Sigma Yellow Belt CertifiedProjects:Led process characterization of late stage recombinant biopharmaceutical protein (E. coli). Including DOE and JMP analysis. Characterization lasted one year and a team of four scientists. Further work included WCB creation, media optimization, and plating studies.Led technology transfer into manufacturing of a Phase III recombinant protein (E. coli). Transferred process to current equipment and scaled up. Included leading a team of five scientists, organizing schedules, writing protocols, and presenting data at client meetings. Additional work performed to increase protein titer successful.Technical Lead for process development transfer project of recombinant protein Phase III (E. coli). Led a team of seven scientists. Work with client to scale up and transfer process. Analyze and present data. Communicate between departments for smooth transition of process steps. General:Created Calendar, Cleaning Program and Scheduling Board to help organize departmentReport findings through presentations and process development reports Plan lab executions, write protocols, and coordinate team schedulesProficient with fermentation and primary recovery unit operations including shake flasks, bioreactor, homogenizer, disk stack centrifugation, depth filtration, UF/DF and tangential flow filtration.Troubleshoot lab equipmentMember of Safety Taskforce

Upstream Process DevelopmentFocus in microbial fermentation and primary recovery Process characterizationDesign of Experiment (DOE)Statistical analysisClient relationsProtocol creation

Maintained and updated membership directory for non-profit national science organization

Interdisciplinary society of scientists that: Encourage achievement and success in science Provide professional developmentPlan Educational seminars and toursProvide networking and volunteering opportunities

cGMP production by cell growth and expression in bioreactorsRecovery and purification using UF/DF, homogenization, centrifugation, chromatographyStudied operations, project management and regulatory compliance (EMEA, FDA, ICH) Quality by Design (QbD) principles and design spaceLaboratory use of WAVE bioreactors, single-use mixers (HyClone) Aseptic fill/finish in biosafety cabinetsStudied GMP 21 CFR parts 210 and 211, as well as ICH Q7aFailure investigation, including root cause analysis Thesis Research:Implementing dissolved methanol gas analysis on 30L bioreactor, probe manufacture, LabView installation and data acquisition, growing Pichia pastoris and scaling up to 30L bioreactor in defined media

Implemented a process analytical technology (PAT) within Granulation Developed a control logic for the technologyWrote a functional descriptionWon a group competition for best Zymeshare website ideasOrganized job shadowing events for interns

Performed manual and automated enzymatic assays on samplesLed Safety Committee with zero time lost to accidentsLed Recognition Committee and helped increase the climate survey resultsMember of project that increased yield of enzyme productCalibrated equipment to ISO 9001 standards monthlyPerformed mechanical maintenance and validated assays Responsible for quality of raw materials, trial materials, and kosher specifications

Interpreted laboratory dataCreated state regulated forms Managed state and public records

Created lab scenarios for hazardous waste prevention and clean up Worked with PPE and enclosed breathing apparatusInspected oxygen tanks