Alyssa Burke Email and Phone Number
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Experienced professional in the pharmaceutical and biotechnology sector with a passion for technology transfer, process validation, project management, and site/project start-up. With 5 years of hands-on experience, I've successfully navigated the complexities of sterile injectables, gene therapies, and API manufacturing. My expertise lies in bridging the gap between R&D and production, ensuring robust processes, and driving project success. Collaborative and detail-oriented, I thrive in dynamic environments, leading cross-functional teams towards efficient and compliant solutions.
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Senior Validation EngineerBarry-Wehmiller Design Group Mar 2022 - PresentSt Louis, Missouri, UsProjects:March 2023 to Present -- Process Validation Lead• Develop and support process validation approach for novel API manufacturing process, including authoring of PPQ protocols and summary reports, and batch execution. • Constructed extractables and leachables risk assessment report for process from drug addition through packaging.May 2022 to March 2023 -- Technology Transfer Subject Matter Expert• Managed stability batch execution for tech transfer program including closeout of critical items for regulatory submission and readiness for batch execution. Led weekly meetings to track progress.• Drug product owner responsible for managing the technology transfer of five products across four filling lines (twelve total products) as part of a site modernization project.• Generate Development and Stability Batch Protocols and Summary Reports, Risk Assessment Reports, Gap Assessments.• Provide on-the-floor support for stability batches of multiple drug products across formulation and filling. • Contribute to a cross-functional team identifying points of process improvement across the entire tech transfer project.August 2022 to January 2023 -- Focus Team Lead• Manage a cross-functional team consisting of process engineering, maintenance, operations, global engineering, and manufacturing excellence to improve performance of a syringe filling line. • Lead weekly meetings to discuss roadblocks, areas of improvement, assign actions and drive them to completion. -
Validation EngineerBarry-Wehmiller Design Group Sep 2020 - PresentSt Louis, Missouri, UsProjects:April 2021 to May 2022 -- Production Engineer • Reviewed Stability Batch Protocols and Summary Reports, Development Batch Protocols and Summary Reports, Risk Assessments, FMEAS, and Gap Assessments for the tech transfer of over 50 aseptic and terminally sterilized drug products into a new facility. • Authored and published Standard Operating Procedures (SOPs), Job Aids, and Batch records for the Formulation/Solution Prep area of sterile injectables plant. • Developed an On-the-Job training for formulation operations and led batch record trainings for formulation operators. • Provided operational support and troubleshooting of formulation process and equipment as needed.November 2020 to April 2021 -- CSV Engineer • Generated and executed IOQ documents for QC osmometers• Managed protocol execution, data collection, and deviation resolution for user authentication protocols aimed at data integrity remediation.September 2020 to November 2020 -- Validation Engineer• Reviewed technical development history, Stage 1 through Stage 3 Process Validation documentation, product control strategy, design history, and batch records for metered dose inhaler in order to develop a trace matrix of process changes from clinical batches to current commercial production.• Revised the product control strategy to include the packaging line.• Identified and proposed process changes to minimize risk and improve process efficiency. -
Bioprocess EngineerNovartis Gene Therapies Jul 2019 - Sep 2020Basel, Baselstadt, Ch• Author Validation Summary Reports for a variety of manufacturing equipment.• Assist CQV team in the execution of Commissioning and Qualification protocols. • Train operators in process activities, equipment, and GDP relating to operations. • Author revisions of SOPs, including identifying areas of document and process improvement.• Collaborated with a cross-site platform team to harmonize operations at three sites.• Subject matter expert for cell expansion operations. -
Research AssistantMucociliary Clearance And Aerosol Research Laboratory Jun 2017 - Jul 2019- Completed experiments utilizing radio labeling of nasal drugs and 3D printed nasal models to determine where aerosol drugs deposit in the nasal cavity.- Created and executed a protocol to analyze the efficacy of a nasal nebulizer in comparison to nasal sprays.- Conducted cascade impactor experiments in order to determine the properties of electronic cigarette aerosols - Assisted in radiation experiments aimed at radio labeling the aerosol from electronic cigarettes- Worked to design an experiment in order to quantify the amount of nicotine that is deposited on filters in electronic cigarette experiments using UV-vis spectroscopy- Presented research at IAC 2018 and ISAM 2019- Aided in clinical trials of ozone induced inflammation of the airways using a gamma camera for transmission scans.
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Teaching AssistantUnc Department Of Biomedical Engineering Jan 2019 - May 20191 semester as a TA for the Biomedical Engineering Sophomore Design and Manufacturing Course at UNC (BMME 210). Assisted students with projects and assignments involving CAD and basic electronics/circuitry.
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Bme AmbassadorUniversity Of North Carolina At Chapel Hill May 2018 - May 2019Chapel Hill, Nc, UsThrough this position I was able to aid incoming and prospective students interested in Biomedical Engineering at UNC by leading tours and providing a point of contact for any questions and concerns. -
Teleflex Mentorship ProgramTeleflex Incorporated Jun 2018 - Jun 2018Wayne, Pa, UsWorked alongside a mentor to identify a product in the respiratory branch that could be improved and formulated a solution to increase this product's quality, while also participating in professional development workshops. -
Head LifeguardUniversity Of North Carolina At Chapel Hill May 2017 - Aug 2017Chapel Hill, Nc, Us -
Lifeguard/Swim InstructorUniversity Of North Carolina At Chapel Hill May 2016 - Aug 2017Chapel Hill, Nc, UsWork as a part of a team of lifeguards to,Recognize and respond to emergency situations, Enforce rules and regulations in order to ensure the safety and satisfaction of patrons, Teach swim lessons individually and in groups to individuals aged 3-30,Maintain records of first aid, incidents, chemical levels, and pool statistics,Greet patrons as they arrive and provide them with information regarding the facility, Respond to complaints from patrons and take actions to resolve them.
Alyssa Burke Skills
Alyssa Burke Education Details
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University Of North Carolina At Chapel HillBiomedical/Medical Engineering -
North Carolina State UniversityBiomedical Engineering
Frequently Asked Questions about Alyssa Burke
What company does Alyssa Burke work for?
Alyssa Burke works for Barry-Wehmiller Design Group
What is Alyssa Burke's role at the current company?
Alyssa Burke's current role is Sr. Validation Engineer at Barry-Wehmiller Design Group.
What is Alyssa Burke's email address?
Alyssa Burke's email address is al****@****inc.com
What schools did Alyssa Burke attend?
Alyssa Burke attended University Of North Carolina At Chapel Hill, North Carolina State University.
What skills is Alyssa Burke known for?
Alyssa Burke has skills like Communication, Customer Service, Lifeguarding, Solidworks, Python, First Aid, Matlab, Swim Instruction, Aed, Microsoft Word, Microsoft Excel.
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