Melissa George

Directs raw material technical transfers to maintain consistency in CMC deliverables.

Founded and led a Regulatory Health Authority Compliance Community of Practice.

Prepares technical documentation and information to support regulatory filings, BLA, MAA, and IND, related to the controls of raw materials.

Supervised lifecycle support for raw materials in clinical and commercial production environments.

Refined material qualification processes through collaborative efforts with stakeholders per ICH and IPEC guidelines.

Formulated raw material specifications adhering to GMP, safety, quality, and scientific regulations.

Determined analytical requirements and orchestrated testing with internal and external labs.

Advised development teams on material selection focusing on scientific integrity and compliance.

Supported upstream potency testing group utilizing cell-based TCID50 assay for vaccines.

Coordinated completion of strategic projects across multiple cross-functional teams.

Delivered timely presentations to leadership regarding project status, phases, and expected results.

Managed projects aimed at developing new methods for Clinical Phase IV residual assays.

Completed and reviewed capital and expense funding requests for various projects.

Investigated deviations, closing and submitting reports while initiating CAPAs in Trackwise.

Authored Standard Operating Procedures for new cGMP processes to enhance compliance.

Implemented LEAN Six Sigma tools, reducing lead time from 80 days to 40 days, doubling weekly output to 1200 replicates.

Supported technical transfers of manufacturing processes for Phase III clinical supplies and large-scale protein production.

Independently executed a variety of experiments according to scientific protocols and guidelines.

Developed experimental designs for chemically defined media and supplements, establishing essential platform media.

Summarized project results through clear oral and written communications with interpretation of findings.

Utilized lean sigma principles to revise procedures and optimize cell culture processes.

Applied 5S methodologies to organize cell culture storage for improved efficiency.

Conducted root cause analysis to identify and solve cell culture challenges.

• Analyzed data to guide key process decisions and improve product yield.

Performed daily metabolic assays, media preparation, sub-culturing, mammalian cell culture, and cell counting. Manufactured media and buffer for use in the manufacturing of biopharmaceutical bulk production using sterile processing techniques.

Participated in harvest tank operations to produce biopharmaceutical bulk GMP production.

Collected, transferred, and inspected all samples obtained while strictly following cGMP/GLP guidelines established by the FDA.

Other activities included revising and creating standard operating procedures (SOPs) and client batch records, as well as material specifications.