Rachel Heister
Master Data Analyst at Emergent BioSolutions- Claim this Profile
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Bio
Experience
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Emergent BioSolutions
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United States
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Biotechnology Research
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700 & Above Employee
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Master Data Analyst
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Aug 2021 - Present
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WuXi Advanced Therapies
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United States
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Biotechnology Research
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200 - 300 Employee
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Process Development Scientist
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Jun 2019 - Dec 2020
Philadelphia, Pennsylvania Solving complex problems and setting scientists up for success by bringing GMP expertise and a continuous improvement mindset to a research and development laboratory.
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Process Development Scientist
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Jun 2019 - Dec 2020
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Manufacturing Associate III
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Mar 2018 - Jun 2019
Greater Philadelphia Area ● Works across boundaries with Process Development, QA, Clients, Metrology, Facilities, and various other departments to create and implement new programs for clients using disposable equipment ● Leads activities within production facilities to ensure the successful manufacture of Viral Vectors, Lenti virus processes, and final product fills, according to current Good Manufacturing Practices (GMP) in conjunction with support systems (e.g.LIMS) while overcoming daily setbacks in a fast paced… Show more ● Works across boundaries with Process Development, QA, Clients, Metrology, Facilities, and various other departments to create and implement new programs for clients using disposable equipment ● Leads activities within production facilities to ensure the successful manufacture of Viral Vectors, Lenti virus processes, and final product fills, according to current Good Manufacturing Practices (GMP) in conjunction with support systems (e.g.LIMS) while overcoming daily setbacks in a fast paced environment ● Trains, coaches and mentors others on aseptic and operational techniques such as media preparation, upstream and downstream operations, specific unit operations and overall systems. ● Revises and reviews simple and complex SOP’s; Executes, revises, authors and reviews simple and complex Batch Records for compliance, accuracy, and efficiency ● Suggests, participates, leads and implements continuous improvement ideas. PROCESS EXPERIENCE: AKTA Avant, Ready, and Pilot NucleoCounter NC-200; PendoTECH and Scilog Pressure monitors; M1 Filler; Cell and Hyperstacks Infection and Transfection Vectors, Cell Banking, TFF, Final Fills, Clarification, Column Clean and Store Lenti Platform (BR writing, execution, Change Controls, process improvements) Batch Record revisions, SOP revisions, Change Controls, Process Improvements, NCE investigations
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Biopharmaceutical Mfg Assoc
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Jul 2015 - Mar 2018
-Performs daily manufacturing tasks per standard operating procedures and batch document instructions in order to maintain GMP standards. -Monitors critical process parameters and participates in effective troubleshooting of equipment and processing problems. -Optimizes resources through lean management and working across boundaries to understand the full scope of the process’s needs. PROCESS EXPERIENCE: 1250L seed bioreactor, 5000L production bioreactors Flow Integrity… Show more -Performs daily manufacturing tasks per standard operating procedures and batch document instructions in order to maintain GMP standards. -Monitors critical process parameters and participates in effective troubleshooting of equipment and processing problems. -Optimizes resources through lean management and working across boundaries to understand the full scope of the process’s needs. PROCESS EXPERIENCE: 1250L seed bioreactor, 5000L production bioreactors Flow Integrity Tester (FIT), SOLO slope electrometer Affinity, Cation Exchange, Anion Exchange chromatography columns, QSFF and PSFF column packing Cell culture inoculation of 5000L production bioreactors Cell viability and control strategies based on DO, pH, CO2 Batch Record revisions, SOP revisions, Change Controls, Process Improvements, NCE investigations Large scale cation and anion chromatography SAP/M-ERP system, Delta-V Operating System, Microsoft Office AWARDS & PROJECTS: ● 6S of Buffer Prep and Harvest processing suites for MVS ● 6S of Buffer Prep and Cell Culture processing suites for CCVS ● ERA award for Column Packing support Show less
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Philadelphia University
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United States
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Higher Education
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400 - 500 Employee
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Office Assistant
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Aug 2012 - May 2015
Philadelphia, Pa -Cooperates with students, parents, and government officials with complaints, personal issues and investigations - Assists with office tasks such as student file organization, taking and recording phone calls, and directing questions to the correct departments - Handled student controversy on an unbiased professional level, leading to my position on the Dean’s Council
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Laboratory/Teaching Assistant
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May 2013 - Aug 2014
Greater Philadelphia Area -Prepared all materials for Chemistry I and II, Biology I and II, and General Physics labs -Organized and cleaned all laboratories in the science department, including the Gross Anatomy lab where special preparation and moving of the cadavers is only privileged to a couple workers -Handled any hazardous materials and exercised appropriate care in handling and disposing of such materials - Assisted instructors in the delivery of quality learning and teaching for students in Chemistry… Show more -Prepared all materials for Chemistry I and II, Biology I and II, and General Physics labs -Organized and cleaned all laboratories in the science department, including the Gross Anatomy lab where special preparation and moving of the cadavers is only privileged to a couple workers -Handled any hazardous materials and exercised appropriate care in handling and disposing of such materials - Assisted instructors in the delivery of quality learning and teaching for students in Chemistry II and Biology I and II laboratory courses by instructing students in the use and care of equipment and materials - Guided students individually or in small groups to master assignments and to reinforce learning concepts presented by instructors - Consulted on the reconstruction of the Biology laboratory course syllabus.
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Education
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Thomas Jefferson University
Bachelor of Science (BS), Chemistry