Miranda Burnette Email & Phone Number

Birmingham, Al, Us

Research and Development Team• Serves as R&D team lead within the cross-functional team developing a complex biologic currently in Ph. III trials as an investigational new drug (IND) en route to a biologics license application (BLA)• Works cross-functionally & across sites with quality control, quality assurance, clinical, process development, & regulatory groups to achieve chemistry and manufacturing controls (CMC) and other requisite deliverables• Performs & collaborates on internal/external analytical method development, from proof-of-concept testing to transfer/validation; leads the accelerated development of a novel cell-based potency assay accepted by FDA for Ph. III• Works collaboratively to develop & implement release tests & specifications, characterization testing & forced degradation studies, & stability & reference standard programs• Co-authors & reviews CMC sections of regulatory filings (including INDs, briefing packages, etc)• Works internally & externally (CROs/CMOs) to ensure timely execution of necessary deliverables and to resolve development & production issues (deviations, OOS/OOT, etc)• Strong experience in technology transfer of assays, technologies, & processes (internally, across sites, & externally)

Birmingham, Alabama Area

Department of Microbiology, Advisor: Christopher Klug, Ph. D.UAB-HudsonAlpha Center for Genomic Medicine T32 TraineeClinical and Translational Sciences Training Program Scholar (January - July 2016)• Focused on a cutting-edge precision medicine initiative to identify new drug treatments for patients with chemoresistant leukemia by combining next-generation sequencing with high-throughput drug screening (manuscript in preparation).• Clinical trial protocol currently being written to translate research findings into patient treatments• Isolated tumor cells from blood and/or surgical/biopsy specimens; prepared cells for drug screening (FACS), DNA/RNA samples, and libraries for next-generation sequencing.• Responsible for kick-starting similar initiatives in breast and ovarian cancer—obtaining regulatory approval, coordinating sample acquisition with clinical partners (physicians, pathologists, nurses), optimizing sample processing and assay conditions.• Gave 2 invited presentations at external symposia, presented 2 posters at national conferences.• Selected as one of 2 trainees for UAB-HudsonAlpha Genomic Medicine Training Program in 2016.• Selected as one of 25 trainees in the Clinical and Translational Sciences Training Program, a certificate program providing training how scientific discovery is translated from the bench to the bedside.

University Of Notre Dame, Notre Dame, In

Department of Chemical and Biomolecular Engineering, Advisor: Jeremiah Zartman, Ph. D.Thesis: Advanced screening and integrative analysis for biotechnology and disease.• First-authored 2 publications describing the first defined culture media for Drosophila cells and characterizing the role of identified molecules in organ development• Submitted US and international patent applications (pending) to protect media through ND Technology Transfer Office• Co-authored a publication describing a novel druggable target in breast cancer metastasis• Gave invited presentations at 4 conferences, including 2 at the premier national Chemical Engineering conference• Responsible for initial set-up of the laboratory, including identifying, purchasing, and setting-up equipment (from basic pipettes to advanced robotics)

Center For Microfibrous Materials Manufacturing, Auburn University, Al

Department of Chemical Engineering, Auburn University, Advisor: Bruce Tatarchuk, Ph. D.• Fabricated and evaluated performance of novel microfibrous media for air filtration

Eastman Chemical Company, Kingsport, Tn

Polymers Technology: Extrusion Applications and Development• Characterized the compatibility of novel plasticizers with Eastman co-polyesters and published work internally

Doctor Of Philosophy, Master Of Science, Chemical And Biomolecular Engineering

Thesis: Advanced screening and integrative analysis for biotechnology and disease.

Uab-Hudsonalpha Genomic Medicine Postdoctoral Trainee

Training program providing the skills necessary for the conception, planning, and conduct of research in genomic medicine and subsequent.

Bachelor Of Chemical Engineering, Chemical Engineering

Spirit of Auburn Founders Scholarship ($32,000 over four years) Tau Beta Pi Member (Engineering Honor Society, top 1/8 of class).

Clinical And Translational Science Program Scholar

6-month certificate program providing training in clinical and translational research, specifically in the following areas: Clinical.