Kimberly Mendes Email & Phone Number

Boston, Massachusetts, Us

Cambridge, Massachusetts, Us

Responsible for defining strategic approaches to develop novel formulations and analytical characterization for two new classes of naturally-derived medicines.Specifically-Define and develop formulation and characterization strategies for potential consumer and pharmaceutical pipelines-Build a high performing formulation and analytical development team to achieve aggressive goals and timelines-Manage employees and hands-on operations of the company's formulation and analytical function, both internal and outsourced-Play an active role in negotiations and oversight of development and manufacturing partners and critical raw material suppliers-Ensure that, as the company grows, capabilities meet or exceed all industry and customer requirements for cost, quality and responsiveness-Develop and manage budget and budget execution-Direct all formulation development and associated analytical characterization-Work closely with R&D group to develop and deliver novel controlled release oral formulations, assays, and analytics-Develop a deep understanding of relationships between the structure and function of the novel modalities and associated formulations-Serve as primary author for relevant CMC sections of regulatory submissions-Cross-functionally identify, correct, investigate and resolve all quality issues in a timely and efficient manner-Develop production and resource plans that meet production goals in terms of safety, quality, output and cost

Fort Lauderdale, Florida, Us

Founded an analytical development team responsible for the technology transfer, assay verification, development, optimization, routine, and stability testing of biologics using a variety of analytical techniques. Directed a team of process development scientists responsible for the technology transfer, verification, optimization, and scale-up of the bio-conjugation of recombinant proteins and antibodies. Specifically-Managed the daily activities of the Protein Characterization and the Bio-conjugation divisions composed of Bachelor-, Master-, and Ph.D.-level scientists.-Developed bio-conjugation and protein modification processes, purification strategies, and analytical characterization for projects including proof of concept, process development, technology transfer, formulation, and stability. -Worked collaboratively with the manufacturing team to successfully transfer and scale-up the developed methods for GMP manufacturing. -Oversaw and provided cross-functional support to the Quality Control division by writing SOP’s, Validation and Qualification Protocols and Reports, interpreting results, solving complex technical problems, and reviewing all stability data and reports. -Communicated directly with clients and vendors to manage multiple projects simultaneously. -Responsible for the technical review of all scientific reports from the Process Development and Quality Control Laboratories. -Provided protein characterization to upstream processing, downstream processing and bio-conjugation divisions in developing bioreactor, protein purification and protein bio-conjugation strategies. -Optimized or developed new characterization methods as needed and establishes protein characterization expertise within the CMO environment. -Trained and mentored junior and senior level scientists.

Fort Lauderdale, Florida, Us

Miami, Fl, Us

Managed a team composed of bachelor- and master-level research scientists that screen diverse chemical libraries to identify novel disease biomarkers for the development of a blood-based diagnostic test for diseases including Mycobacterium Tuberculosis, Rheumatoid Arthritis, Multiple Sclerosis, Neuromyelitis optica, Alzheimer's Disease, colon and lung cancer, and Type I Diabetes..Managed the team’s work load, developed project goals, designed experimental plans, oversaw the development and optimization of methods, critically analyzed results and prepared written and oral reports on research findings.Developed and validated methodology for a fast and effective isolation of high-affinity bead-displayed hits by utilization of magnetic particles.Developed a two-color bead screen utilizing flow cytometry single bead fluorescent sorting technology.Identified IgG ligands that distinguish active and latent Mycobacterium tuberculosis infections through the use of a high-throughput flow cytometry-based screening strategy to sort bead-displayed ligands encoded with DNA.Implemented a multiplexed flow cytometry assay for validation of screening hits.Regularly presented results to OPKO colleagues and executives, or professional collaborators from the pharmaceutical industry.

Us

Optimized printing peptoid ligands onto a glass microarray platform for analysis of human plasma samples to develop a high throughput Alzheimer’s diagnostic test.

Us

Synthesized diverse peptoid libraries on TentaGel beads to directly screen for binding to the protein targets p53, MeCP2, and BRD4. Hit compounds were characterized for the ability to reactivate the mutant forms of p53 and MeCP2 to act as molecular chaperones for cancer and Rhett Syndrome therapeutics respectively.

Chestnut Hill, Ma, Us

Genetically incorporated the unnatural amino acid L-(7-hydroxycoumarin-4-yl) ethylglycine into E. coli aspartate transcarbamoylase (ATCase) to dissect the allosteric interactions of nucleotide effector molecules by fluorescence, kinetics, and stopped-flow spectroscopy.Performed kinetic characterization and X-ray crystal structure determination of a cooperative ATCase species formed by disulfide-linked catalytic subunits and chemical dissociation of regulatory subunits.Employed X-ray crystallography to elucidate important conformational changes associated with substrate binding, catalysis and product release mechanisms within the catalytic cycle of ATCase.Served four semesters as a recitation instructor for Biochemistry I & II. Held weekly hour-long interactive reviews on topics ranging from protein structure and function to recombinant DNA technology.

Performed comparative analysis of the retrogradation process effects of Modified Atmosphere Packaging versus Oxygen Scavenger Packets for Meal Ready to Eat (MRE) Bread.Utilized chemiluminescent antibodies to detect bacterial contamination of food samples and optimized the use of a new military field instrument, the Microbial Vacuum, to efficiently remove contamination.

Ph.D, Biochemistry

B.S., Chemistry, Economics