Lisa (Dietrich) Jeffers Email & Phone Number

Gaithersburg, Maryland, US

Gaithersburg, Maryland, US

Regulatory lead for a commercial vaccine approved in four markets (US, Canada, Singapore, Australia). Responsibilities include development and timely communication of regulatory strategy, collaboration and alignment with functional SMEs to define timelines and strategy, authoring and review of eCTD content for submission to regulatory agencies, responding.

Tarrytown, New York, US

Led creation of a new function responsible for developing processes to ensure drug supply distribution compliance (beyond GMP compliance) with all aspects of global regulatory filings to support stable supply positioning. Oversaw and managed workload of up to six direct reports and defined strategic plan for group. Collaborated cross-functionally to.

Tarrytown, New York, US

Oversaw and managed workload of up to five direct reports; collaborated with other managers to define strategic plan for group. Project lead or functional manager for PQR and Yearly Biological Product Review (YBPR) reports for five commercial programs. Spearheaded efforts to define and execute strategy for generation of first PQR summarizing activity from.

Tarrytown, New York, US

Managed generation of Product Quality Review (PQR) reports for commercial products. Participated in the generation of Yearly Biological Product Reviews (YBPRs) for commercial products. Supported regulatory agency inspections. Worked with cross-functional teams to continuously improve processesFulfilled information requests from external partners, as.

Providing affordable, high-quality calligraphy services for weddings and other special events! Please email for more information!lmjeffers@calligraphydesigns.netwww.calligraphydesigns.net

Designed, implemented and maintained an FDA-compliant electronic SOP system. Designed, implemented and maintained a quality management system to manage Quality Records. Assisted in the preparation of documents for submission to the FDA, including INDs and annual reports. Managed the stability program for lead monoclonal antibodies. Maintained.

Design, execution, qualification and troubleshooting of assays in support of preclinical development of lead therapeutics. Specialized in ELISA-based assays, but also developed cell-based functional assays and performed animal studies.

Design, execution and troubleshooting of molecular biology experiments. Responsibilities included PCR amplification, isolation and cloning of heavy and light chains, selective mutagenesis to improve antibody affinity, transient transfections, ELISA assays to test antibody production and specificity, analyzing of large bodies of sequencing data, and.

Under the direction of a supervisor, execute and troubleshoot molecular biology experiments.

Under the direction of a supervisor, conduct PCR, run gels, and help molecular biology scientists with the execution of their experiments.

New York, New York, US

Acquired hands-on experience in an industrial research setting. Gained experience with tissue staining protocols and microscopy.

Rochester, NY, US

Studied the relationship between the function of Apolipoprotein E (ApoE) and brain microvascular formation using a capillary tube formation assay in mouse brain endothelial cells in ApoE transgenic mice.

Potsdam, NY, US

Developed and implemented independent research project involving the evolution of desiccation tolerance in Drosophila subobscura along a latitudinal cline.

Potsdam, NY, US

Developed and implemented independent research project involving the evolution of desiccation tolerance in Drosophila subobscura along a latitudinal cline.

Master Of Science - Ms, Engineering Management

B.S., Biology