Experience

Novavax

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Stability Specialist III

  • Dec 2021 - Present

  • Supports stability testing at CMOs/ OTLs • Provides initial evaluation and presents solutions for consideration on complex issues and challenges. • Records changes or updates to controlled documents (i.e. SOPs, Forms, Sample Plans, ISS, & Final repots) • Conducts investigations, process deviations, OOS and CAPAs • Works cross-functionally with internal departments and with CMO/OTLs to ensure manufacturing schedules, sample shipments, sample receipts, testing status, inventory and represent the Stability Team • Drafts, reviews, and revises Flu IND sections, as well as support Covid BLA initiatives • Compiles, trends, and analyzes stability data in JMP for presentations and reports per ICH guidelines or as needed by management. Show less



Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Sr Sample Management Coordinator

  • Nov 2014 - May 2023

  Internship in Biostatistics-Global Development ●Import, clean, and merge Fel D1/ Bet V1 allergy datasets for further analysis ●Perform basic statistical analyses, in addition to power analysis to support downstream study collaborations ●Independently performed Bet V1 literature reviews and discussed results with the principal statistician. ●Coding and creating new variables in the preparation and production of statistical charts and tables to discover trends and associations within allergy studies. Sample Management Associate II ●Independently handles high priority and high-volume sample management activities in clinical and nonclinical therapeutic areas; including but not limited to usage of protocols, supporting documents, ELN and LIMS to create studies, accession and track non-clinical/clinical samples via assessing and verifying data and maintaining documentation. ●Maintains effective verbal and written communication both internally and with external collaborators and vendors. Communicates with CRO’s and third-party vendors to support sample management responsibilities. ●Assists in the reconciliation of study samples and proactively identifies, troubleshoots, addresses inconsistencies in area of technical expertise or assignment with limited direction to drive deliverables forward. ●Works closely with Quality Control (QC) and Quality Assurance & Auditing (QAA) to address findings and ensure data is captured appropriately in LIMS as well as preparation of supporting documents, if applicable, for study audit activities. ●Collaborates with Sample Management Group (SMG) to produce a poster on more efficient SMG methods of standard operating procedures in addition to working with the Assay Development Group (ADG) to develop internal cut point analytics using JMP and Excel. Show less



The Judge Group for Stryker Orthopaedics, Malvern, PA

• Malvern, Pennsylvania, United States

• Quality Control Technician

  • Jul 2014 - Nov 2014

  ●Conduct routine and non-routine analysis on incoming inspection of raw materials, in-process, and finished formulations according to established procedures by use of XRD, FTIR, Tensile Tester, and wet chemistry. ●Support Quality functions dealing with system performance such as NCMR's ●Maintain data integrity and ensure compliance with company written procedures and specifications. ●Assist the Sr. Analyst in the development or validation of new or existing analytic methods. ●Participate in continuous improvement activities and process re-engineering projects in support of continual improvement initiatives. ●Demonstrate the ability to work effectively with various workgroups to assure conformance to regulatory requirements, internal processes, and policies. Show less



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Molecular Technician I & II

  • Oct 2011 - Jan 2014

  ●Conduct assays and lab procedures according to and in compliance with GLP and/ or cGMP guidelines and SOPs through the use of PCR/qRT-PCR and Sanger sequencing. ●Perform laboratory activities necessary for molecular biology testing including but not limited to, reagent preparation, laboratory maintenance/ monitoring, ●Accurately complete batch records and other required documentation according to and in compliance with GLP and/or GMP guidelines and SOPs. ●Accurately analyze data and report results of assays and procedures ●Prepare samples to be subcontracted. ●Assist in training subordinate personnel on known tests and procedures. ●Maintains laboratory notebook and follows all general and laboratory SOPs Show less



Rutgers University

• United States
• Higher Education
• 700 & Above Employee

• Laboratory Technician

  • May 2010 - Oct 2011

  ●Using aseptic and wet chemistry techniques to process media and stock solutions and preserve bacterial cultures for further studies. ●Performing UV spectroscopy of cells and membranes to identify growth and health. ●Documenting and presenting a detailed report outlining analysis and research results in collaboration with a primary investigator. ●Quantifying quinone content of cell chromatophores using HPLC. ●Aiding and assisting undergraduates to learn new instrumentation and techniques. ●Working with collaborative labs to maintain cell lines for external study. Show less



Medical Diagnostic Laboratory, Inc.

• Medical Practices
• 1 - 100 Employee

• QC Technician/ PCR technician/ Accessioner

  • Sep 2008 - Mar 2011

  QUALITY CONTROL TECHNICIAN -Efficiently performed accessioning QC evaluations of test requisitions and documents. -Successfully conceptualized and interpreted test results as well as verifications of results in dMDL. -Distributed ambiguous results to laboratory for repeat testing or R&D department for reconfirmation; performed follow up on test returns. CLINICAL LAB TECHNICIAN -Assumed full accountability for DNA extraction from thin preps, urine, and blood samples. -Executed thorough-put STD testing in accordance to GLP standards. -Conducted viral and microbial infection analysis on in-process samples with qRT-PCR while maintaining conformance to GLP standards. -Proactively analyzed and reported results to QC department; carried out methods and /or results troubleshooting, as necessary. -Constantly updated the laboratory notebook with detailed account of changes and progresses. -Ensured conformity to laboratory safety procedures/practices. ACCESSIONER -Primarily held responsible for the viability of specimen for testing and Registered test requisition forms into dMDL. Show less