Ellen Lawrence Email & Phone Number

Gaithersburg, Maryland, United States

Gaithersburg, Md

Develop, qualify, validate and perform technology transfer of test methods for the characterization and release of protein components for vaccines in a GXP environment. Serve as a subject matter expert in method development and routine testing of in-process samples from process development and formulation development. Provide consultation and leadership site-wide on creating a quality infrastructure for purposes of documenting analytical testing results. Partner with purchasing and shipping & receiving departments to proactively manage all department material needs. -Validated 4 test methods (host cell DNA qPCR, host cell DNA sizing, product identity qPCR and TCID50) for MVA Ebola release in less than 3 months, a 75% reduction in the standard timeline for each of the 4 methods-Developed, qualified and implemented release test methods for ELISA and qPCR testing of rPA102 residual host cell impurities on a truncated timeline. Test methods and associated SOPs were developed, written, qualified, reviewed and approved over a period of only 3 months, a 57% reduction from the anticipated target.-Reduced hands on time for ELISA and MLA test methods by 25% by introducing high throughput techniques during sample preparation resulting in greater testing capability and quicker turnaround time from sample submission to data reporting.-Completed compatibility studies on rPA102 ELISA and MLA test methods and successfully demonstrated accurate results from the use of these assays for testing spray-dried and lyophilized product formulations. Authored compatibility study protocols and reports.-Appointed by Site Head and Human Resources to execute an organizational objective and chair a site-wide culture team to identify and address gaps in the site culture. Successfully built a cross functional team and implemented programs and events that improved employee working conditions and boosted morale.

Gaithersburg, Md

Develop, qualify and implement test methods for the detection and/or quantitation of DNA and proteins resulting from VLP transduction. Supervise assay development and serve as subject matter expert for all assays developed and transferred to QC for VLP release testing. Serve as primary analyst and trainer for all QC qPCR testing methods.-Improved qPCR assay performance, robustness and reliability by implementing probe-based qPCR assays and redeveloping a SYBR Green qPCR assay. The changes made to the test methods reduced assay failure rates from over 40% to below 10%.

East Syracuse, Ny

Perform in-process testing on protein products in a GMP environment. Act as subject matter expert for validation and technology transfer of qPCR methods. Serve as primary analyst and trainer on qPCR methods for company personnel as well as CMO personnel. Provide technology transfer technical support and method expertise to CMOs. Develop, validate and implement test methods for use in routine testing of biologics products.-Completed development and execution of SDS-PAGE, western blotting, 2-D gel electrophoresis and silver staining experiments for Orencia© post-marketing commitment and CMO extended characterization studies. Worked as part of a 4 person team over a period of only 2 & ½ months to execute all experiments and provide data analysis for reports submitted to FDA and EMEA. Successfully demonstrated consistency of a host cell protein ELISA reference standard and comparability between the product manufactured by BMS in East Syracuse and product made by our CMO.-Participated in the successful technology transfers of cGMP qPCR testing method from the BMS site in Hopewell, NJ and to CMOs in South Korea and New Hampshire. Successfully trained personnel from both CMOs on the execution of the qPCR method and completed both the training and technology transfers under budget and in less time than originally anticipated.-Successfully completed test method validation for qPCR test methods for Orencia©. Authored validation protocols, validation reports, test methods and associated SOPs. Method validation and associated documents were submitted to and approved by regulatory agencies as part of BLA and supplemental BLA applications.

Bristol-Myers Squibb, East Syracuse, Ny

Subclone and genetically characterize master cell banks used in the production of biologics products. Perform routine cell culture and assays to analyze the genetic stability of subcloned cell lines.-Successfully subcloned master cell bank and generated cell line with higher titer and sufficient glycosylation. Demonstrated genetic stability of subcloned cell lines. Provided gel electrophoresis, southern blotting and northern blotting results that indicated subcloned cell lines were a genetic match to master cell bank and that the genetic identity of the subclones did not change over time.

Breitwieser Laboratory, Syracuse, Ny

Develop assays to demonstrate the activity of the calcium-sensing G-protein coupled receptor. Worked with principal investigator, post-doctoral associates and graduate students to develop and execute experiments for the purposes of publishing scientific knowledge and furthering the understanding of protein structure and function.-Utilized point mutation, restriction enzyme digests and DNA ligation to successfully develop chimeric G-protein coupled receptors. The chimeric receptors were used to determine what domains of the calcium sensing protein were required for receptor activation. Developed, implemented and executed a luminescent assay for analysis of calcium sensing receptor activation.

Boston, Ma

Assist principal investigators, post-doctoral associates and graduate students with research projects relating to chronic myeloid leukemia. Conduct experiments and perform procedures under the supervision of various laboratory personnel.

Masters Of Science, Biotechnology

Masters Degree, Business Administration

Bachelor Of Science, Biology

Activities and Societies: Summa Cum Laude; Dean’s List; Top 5% of Class; Phi Kappa Phi Honor Society; Sigma Xi Research Society; Tri-Beta.