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Quality Control Molecular Biology

Location:
Fallbrook, CA
Posted:
March 03, 2025

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Resume:

Novelle Kimmich

**** ***** **. *********, ** ****8

*********@*****.***

562-***-****

Education

Ph.D. Biochemistry and Molecular Biology

****-**** - ********** ** ********** Irvine

Emphasis: Structural and kinetic characterization of a newly discovered bacterial homologue of human P450 with increased solubility and stability as a model for drug clearance mechanisms.

M. S. Biochemistry and Molecular Biology

2001-2003 – University of California Riverside

Research: Investigation and characterization of allosteric interactions of Tryptophan synthase. Synthesis of novel alpha site ligands designed to trap the beta site in intermediate states to elucidate kinetic and structural mechanisms of product formation.

B.S. Biochemistry

1999-2001 – University of California Davis

Research

2023 Grifols - Scientist (remote contract)

●Supported R&D activities for the UltrioPlex W project under Edgar Ong

Feasibility and optimization of the assay using Design of Experiment

Validation and Verification: Drafted and edited protocols, reports, deviations, and study summaries for regulatory submission. Quality checked analysis of data and report tables.

Drafted and consulted on risk documentation, including Design Failure Mode and Effect Analysis

Presented at Core Team meetings

2019 Grifols – Scientist III

●Lead scientist under Edgar Ong and Sunghae Joo for the Procleix Quality Control project.

oLed a team of research assistants from project design, experiment design, material selection, data generation/analysis, and protocol/report drafting for the preparation of the FDA 501k regulatory submission.

oParticipated in multi-department project meetings to coordinate project progress with Labeling, Manufacturing, Quality Control, Quality Assurance, and Regulatory.

●Customer complaint investigation for the DiaMex controls resolved by quantification of DiaMex material and determination of lower than expected concentration.

●Characterization and initial specifications set for novel viral targets (Chikungunya and Usutu) for the ArboPlex assay.

●Conducted Verification and Validation experiments including the protocol and report drafting to support the release of UltrioPlex E.

●Proficient in the use of the Panther instrument and the preparation of Procleix Assay reagents.

●Experienced user of electronic Document Management Systems

2018 Edeniq – Research Scientist PI: Scott Snyder

●Analytical method development

oHelped develop the world’s first direct cellulose method to assist ethanol refineries in production of cellulosic ethanol. Method reports on anomeric configuration of sugars through GCMS.

oUtilized affinity chromatography (IMAC) for HPLC analysis of monosaccharides, oligosaccharides and polysaccharides

oLed a team of researchers in improvement of colorimetric assays resulting in cost savings of over 80% for this class of assay.

oImproved HPTLC methods for reaction monitoring

oImproved sample cleanup via solid phase extraction (SPE) and enzymatic digestion

●Utilized quality by design paradigm for improvement of assays

●Developed Excel templates for more efficient data processing. Reviewed and updated SOPs. Kept notebooks GMP compliant.

2011 Cincinnati Children’s Hospital – Post Doctoral Fellow PI: Dr. Nicolas Nassar

●Expressed and purified a variety of mutants of Sts1 (suppressor of T-cell signaling) for characterization of kinetics via stop flow.

●Optimized purification of the N terminal domain of Sts1 and a crystallization technique which allowed diffractable crystals

2004-2010 U. C. Irvine – Doctoral research PI: Dr. Thomas Poulos

●Cloned, expressed, purified, and characterized novel electron transport proteins in P450 systems.

●Performed kinetic analysis of electron transport from Cindoxin to P450cin by monitoring Soret absorption using anaerobic stop flow.

●Screened and improved crystallization conditions of Cindoxin from needle clusters to 2-dimentional plates. Collected and analyzed x-ray diffraction data. Crystals appeared to diffract to 2.7 angstrom resolution, however crystals did not contain a single uniform lattice, and the structure was unsolvable.

●Screened protein expression systems including plasmids, cell lines, and culture conditions to express a previously unexpressed protein Cindoxin Reductase.

●Optimized gene sequence of Cindoxin Reductase for expression in E. coli. and reconstructed gene using PCR.

●Expressed and purified isotopically labeled Cindoxin for NMR studies. Using the programs Sparky and NMR Analysis, a partial assignment of the spectra was made in preparation for measuring distances from the heme iron of P450cin to Cindoxin to identify the specific binding surface using pseudocontact shifts.

2003-2004 U. C. Irvine – Doctoral rotation PI: Dr. Sheryl Tsai

●Developed new kinetic assays to detect the formation of acetyl

CoA from acetyl-CoA synthetase isolated from M. tuberculosis.

●Crystallized acetyl-CoA synthetase and collected X-ray diffraction data from the Stanford Synchrotron Radiation Laboratory (SSRL) from which the crystal structure was solved.

2001-2003 U. C. Riverside –Masters student PI : Dr. Michael Dunn

●Performed chemical synthesis of alpha site ligands for tryptophan synthase. Characterized ligand affinity and allosteric effect using stop-flow, fluorescence spectroscopy, and fluorine NMR.

2000-2001 U. C. Davis – Intern: PI: Dr. John Crowe

●Improved upon method of monitoring lipid raft formation within micelles upon changing temperatures using circular dichroism. Temperature of raft formation was correlated to the concentration of cholesterol.

1998-1999 NASA Ames –Intern: PI: Dr. George Cooper

●Isolated compounds from the Murchison meteorite using ion chromatography. Identified the first extraterrestrial sugar derivatives discovered using gas chromatography-mass spectrometry. Confirmed non-terrestrial origin by isotopic analysis.

Publications

Kimmich Novelle, Das Aditi, Sevrioukova Irina, Meharenna Yergalem, Sligar Stephen G, Poulos Thomas L Electron transfer between cytochrome P450cin and its FMN-containing redox partner, cindoxin.

The Journal of Biological Chemistry 2007;282(37):27006-11.

Ngo Huu, Kimmich Novelle, Harris Rodney, Niks Dimitri, Blumenstein Lars, Kulik Victor, Barends Thomas Reinier, Schlichting Ilme, Dunn Michael F Allosteric regulation of substrate channeling in tryptophan synthase: modulation of the L-serine reaction in stage I of the beta-reaction by alpha-site ligands. Biochemistry 2007;46(26):7740-53.

Ngo Huu, Harris Rodney, Kimmich Novelle, Casino Patricia, Niks Dimitri, Blumenstein Lars, Barends Thomas Reinier, Kulik Victor, Weyand Michael, Schlichting Ilme, Dunn Michael F Synthesis and characterization of allosteric probes of substrate channeling in the tryptophan synthase bienzyme complex. Biochemistry 2007;46(26):7713-27.

Cooper G, Kimmich N, Belisle W, Sarinana J, Brabham K, Garrel L

Carbonaceous meteorites as a source of sugar-related organic compounds for the early Earth. Nature 2001;414(6866):879-83.

Technical Skills

●Cloning

●Mutation

●PCR

●Protein Expression

●Protein Purification

●Kinetics

●Stop Flow

●Crystal Screening

●Collection of X-ray Crystallography Spectra

●NMR

●GCMS

●HPLC – Shimadzu, Agilent and Waters systems – Empower and Chemstation

●SPE

●HPTLC

●Colorimetric assays

●Troubleshooting, maintenance, and repair of instruments (GCMS, HPLC)

In Silico: Microsoft office (Word, Excel, Powerpoint) JMP, Sigma Plot, MSAE, DCM, Design of Experiment (DOE), Swiss PdbViewer, PyMol, Sparky, NMR Analysis.

Conferences participated in

●West Coast Protein Crystallography Workshop 2007, Asilomar CA

●Experimental Biology 2006, San Francisco CA

●14th International conference on Cytochromes P450 2005, Dallas TX

●West Coast Protein Crystallography Workshop 2005, Asilomar CA

●International Society for the Study of the Origin of Life 1999, San Diego CA

Awards and affiliations

●NAPW National Association of Professional Women

●Phi Theta Kappa International Honor Society



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