Maria George Email & Phone Number

Durham, North Carolina, Us

Durham, North Carolina, Us

Direct management of a team of engineers dedicated to technology transfer and validation of upstream manufacturing processes of various complexity. Leading and providing guidance on technical transfer projects for challenging clinical manufacturing programs.Leading complex investigations and troubleshooting efforts and providing recommendations to manufacturing implementation.Providing real-time technical support to manufacturing during campaigns. Supporting IND and BLA filling and providing guidance with US, EU, and ICH regulations and guidelines.

Billingham, Gb

Billingham, Gb

Collaborating with multiple departments within the company, clients, and suppliers to deliver results in fast-paced highly regulated environment.Tech transfer for Upstream and Downstream processes (Fermentation and Cell Culture).Process Validation support, including protocol execution, data reporting, and consumables suitability evaluation according to BPOG standards.Development of GMP documentation: batch records, process validation reports, engineering test plans, engineering protocols.Extensive manufacturing floor support: training of manufacturing staff, process and equipment troubleshooting, deviation investigation and impact assessment.Risk and criticality assessment, FMEA, process mapping.

Bagsvaerd, Dk

New Platforms, Products and Process Development for BioAg, Direct Fed Microbials, Biofuels, Household Care, and other divisions of Novozymes.Liquid fermentation, Solid State Fermentation, and Recovery.Standardization of processes across Novozymes sites.Technology Transfer.

Bagsvaerd, Dk

Dasgip bioreactor fermentation of variety of microbial strains isolated from soil: shake flask process transfer into bioreactors;Fermentation process optimization, troubleshooting, deviation investigation, SOP development; CAPA6 Sigma tools application for process improvement;Process mapping;Microbial strain identification via Maldi TOF and 16S;Achievements: Optimized fermentation worklfow,Reduced contamination rate in bioreactor fermentation from 30% to less than 5%,Developed a Sample Preparation Procedure for fast 16S identification,Developed a method for Bacterial Broth Seed Coating and Extraction with Enumeration

Raleigh, Nc, Us

Managing Cell Culture laboratory, performing process development runs for external clients and internal projects. Instructing NCSU courses and short courses for industry professionals in Cell Culture, Fermentation and Downstream. Writing and editing SOPs and batch records, validating new equipment.

Cambridge, Ma, Us

Operating Large Scale bioreactors (60L -15kL): performing cell growth activities, media and nutrient additions, transfers, inoculations, sampling, etc.Following SOPs and batch records, Operating support area: glasswash, COP bath, Autoclave.Assisting harvest area: TFF and microfiltration;Ordering supplies and performing maintenance work orders, reviewing log books, preparing and sending out reports

Research Triangle Park, Nc, Us

Performed cell culture expansion for the R&D group (Vero, MDCK, MRC-5, BHK);Screened and evaluated media and supplements for growth and production;Performed Serum-Free adaptation of cells;Optimized growth and production and performed culture scale-up;Performed virus titers assays to support development and production.Wrote new and revised existing SOPs and records.Performed routine bioburden testing in development and production samples.

Research Triangle Park, Nc, Us

Scaled-up cell culture bioreactor processes;Optimized media formulation and culture conditions (temperature, incubation time, etc.) for maximum growth and productivity;Assisted in downstream purification (UF/DF and HPLC);Performed in-process assays for titer, DNA, and protein residuals, including Pico Green, BCA, SDS-PAGE

Raleigh, North Carolina, Us

Teaching fundamental microbiology skills and techniques;Grew microbial cultures and preparing samples for students;Performed microbial identification, Prepared instructional materials and assisted in grading

Raleigh, North Carolina, Us

Established animal cell culture technology and processes,- Set up cell culture laboratory, created master and working cell banks,- Started-up and operated stirrer tank bioreactor and Wave Bag.- Performed ordering of supplies, creating and maintaining accounts with vendors and other administrative duties.

Mclean, Virginia, Us

Taking care of laboratory animals, assisted in vaccinations, provided care for sick animals;Performed sampling and maintaining feeding logs

Isolated and maintained pure cultures and performed identification of microorganisms;Prepared teaching supplies: media, cultures, sterile materials and glassware;Assisted in teaching Microbiology labPage 2 of 2

Master'S, Microbial Biotechnology

Master Of Science (Ms), Biology-Ecology