Microbiology SME; IOPQ conversion from ISO to EU (planning / risk assessment / execution / post-execution assessment / routine operations) of a 183,000 sq. ft. biological multi-product development and drug substance manufacturing facility (BSL-2 / BSL-3). IOPQ of a 92,000 square feet new building facility (BSL-2). Development and post execution of environmental monitoring program, utilities (water and gas systems) and contamination control program for expansive single-use technology manufacturing space to include; production, support and final fill manufacturing areas, and technology designed to meet particulate cleanliness levels at EU grades A, B, C, or D. Manufacturing suites for multiple bulk drug substances and drug product biologics using various production methods, starting with cell bank and viral bank expansion, production culture, and purification of target products such as recombinant proteins, plasmid DNA, VLPs, monoclonal antibodies, and antibody derivatives. Development and implementation of cGMP microbiology testing a for all new products (CDMO).Contamination control and aseptic operations, endotoxin, bioburden, suitability, water sampling and testing, BSL3 operations implementation and logistics, finish product and raw material testing, MLT, antibiotic susceptibility testing, growth promotion, BIs, ID, sterility, B&F, PCR, LIMS, MODA, SOP, data review, EM, USP, cGMP, general QC, method development & qualification (viral/bacterial platforms), data reports, EM/UM/Product trending, lean manufacturing, process clean up and waste reduction, inventory control, data management. Media fills, APS, AOQ, SME on microbiological assays, microbial ecology analyses, across the board consultation and support Director/Manager level, Audits, Quality System Event/Dev/CAPA, Yellow Belt, Train the trainer, IOPQ equipment/EM/UM, risk assessments, resources allocation, logistics, planning, cross functional support, quality system management and implementation.

Conducts and interpret microbiological QC analyses to support J&J Ortho Biologics and J&J Ortho Pharmaceuticals sites operations. EM, UM, Endotoxin, packaging component, bioburden, cGMP, GDP, GLP, LIMS.

Conducts and interpret microbiological QC analyses to support Mylan LLC. operations. Microbial sampling and bioburden monitoring EM, UM, raw material, packaging component and finished product bioburden, stability, and validation protocol. Trend analysis of environmental monitoring data, cGMP and GDP application in all laboratory procedures. Media and materials inventory control, data entry, LIMS, documentation audits and reviews, contamination control trainer.

Provided academic assistance to students as individuals or groups. Assisted students in acquiring better understanding of targeted areas within a subject for an entire trimester coursework. Development of individual tutoring plans in accordance with individual needs of students and timeframes. Courses included but not limited to General, Organic and Analytical Chemistry, Biostatistics, Physics, Algebra, Pre-calculus and Elementary Level Math Reasoning.

Quality Control including analytical testing, characterization, method development & validation, and sample and data management. Inventory control and gDNA extractions, purification, and quantification. Analyses of next-generation sequencing data and microbiomics.

Analytical testing, characterization, method development & validation, sample, and data management. Isolation, identification, and maintenance of live cultures under anaerobic and aerobic controlled environment, sterilization of laboratory equipment and media, preparation of standard buffer solutions and growth media.