Amy Eckert Email & Phone Number

United States

West Point, Pa

Within the Biologics and Vaccines Analytics (BVA) group in the Merck Manufacturing Division (MMD) at Merck, I support Vaccine Assay Life Cycle activities across various vaccine franchises and analytical platforms. Provide Analytical Program Development support for the commercialization of Biologics and Vaccines from Phase III through launch, transfer to supply, and in-line support enabling world-wide robust vaccine availability. Write and review protocols and reports for new Biologics and Vaccine BLA and IND filings. Transfer analytical technology to external groups, sites, or contract organizations.

Spring House, Pennsylvania

Contractor at Janssen working in Biologics Research, Cell Line Development And Genetic Characterization.

Philadelphia, Pa

Provide technical knowledge and scientific expertise for assays within the Virology department, specializing in custom, non-routine assays. Transfer and coordinate custom protocols from development to routine operations. Conduct and direct assays and lab procedures according to and in compliance with GLP, cGMP, CFR and other pertinent guidelines. Act as study director as needed. Optimizs and troubleshoot current protocols. Provide operation's testing support to cell therapy manufacturing projects.

• Efficiently implement all facets of new client projects including establishing pricing and initial statement of work, designing and performing research and development experiments, liaising with client, writing protocols, performing assay and submitting final report. Successfully created induction protocol and client specific plaque assay.• Ensure optimal performance and on-time delivery of all projects while partnering with other departments, including sales, molecular biology, cell culture and manufacturing, validation, and quality assurance.• Support virology operations by providing technical guidance to staff including investigating problems with current protocols, designing and performing qualification experiments to meet new regulatory guidelines, corresponding with clients, and performing non-routine virology testing as needed, including assays with primary cells.• Supervise analysts for specific projects including training, scheduling, development, and regular feedback on performance. Provide scientific leadership through mentoring and coaching. Participated in staff evaluations, writing promotion justifications, and recognizing individual and team successes for company awards.• Perform various cell-based assays under GMP to detect the presence of viral contaminants in client samples, monitoring cell growth, observing cytopathic effect (CPE), counting plaque or foci formation and performing hemadsorption (HAD) and hemagglutination (HA) assays.

• Assisted in developing, optimizing and validating an HAI assay to determine influenza virus titers.• Expanded virus lots in SPFF chicken eggs.• Led project in absence of group leader, leading team meetings, organizing experiments, ordering supplies, and liaised with Quality Assurance, Statistics, and Data Management teams.

Systems Biology, Biological TechnologiesProvided cell culture support of parental, transformed, and lentivirus infected cells for team members working on RNA interference (RNAi) and High Content Screening projects (HCS). • Transferred and optimized assays for testing small local compound libraries. • Performed primary cell isolation and culturing to develop on-site assay for hippocampal neuronal cell assay. Automated Cell Culture Group (ACCG), Chemical Screening Sciences•Executed all facets of cell culture to provide large quantities of plated cells (200plates/day/screen, 2 screens) in 384 well format for the High-Throughput Screening group. Projects adapted to the ACCG for scale-up and plating provisions using manual MultidropCombi dispensers or automated robotics, TAP SelecT. • Scheduled daily work responsibilities for 3 temporary employees, following all projects in the ACCG. Provided evening and weekend assistance to third shift employees. • Developed assays for quality control parameters including Cell Titer Glo. • High demands and concurrently running projects required excellent teamwork and communication skills, including daily project updates with multiple team members.Women's Health• Produced stable transfectants containing a sperm Na+/H+ exchanger or rat KCNQ channels for FLIPR–based targets. • TaqMan used to determine upregulation of Cancer Testis Antigens (CTA) in total RNA from normal versus tumor tissue samples.• Investigated and characterized native CHO KCNQ5 channel through siRNA knock down experiments and Western blots. • Proteins expressed in E. coli, baculovirus, and mammalian cell systems. Compared and optimized different expression systems for each protein. • Developed new purification schemes for proteins using Pharmacia AKTA Explorer with ion exchange and affinity chromatography.• Worked independently, presented at team and group meetings, and mentored summer interns.

Bs, Biology, Anatomy

Aas, Biology