Colleen Pope Email and Phone Number
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Skilled scientist and writer with over nine years of professional and academic laboratory experience, including LC MS/MS sample preparation, cell culture, and aseptic technique in a GLP laboratory, as well as sample preparation for SDS PAGE analysis in a GMP laboratory. Industry experience includes designing, writing, and updating required technical documentation covering all CMC areas, including JNDA, BLA, IND, and IMPD submissions. Design of LabVantage software to meet business needs, contributing to the validation and implementation of the LabVantage Stability module.
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Lims ConsultantClarkston Consulting Feb 2020 - PresentDurham, Nc, Us
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Study Director, Cmc Analytical Outsourcing And StabilityEisai Us Jun 2014 - Feb 2020Nutley, Nj, Us• Serve as the Study Director for CMC programs and provide support for multiple programs• Responsible for timely release of drug substance through quality review of QC data.• Co-lead efforts with the site Director for each of the products • Prepare and technically review reports for regulatory submissions and documents for publication, including JNDA, BLA, IND, and IMPD dossiers.• Serve as the business owner project lead for the configuration, validation, and implementation of LabVantage Stability software.• Author the User Requirement Specification (URS) for LabVantage Stability module implementation.• Coordinate efforts with IT to accomplish LabVantage project deliverables, including system configurations to meet business and URS needs.• Manage consultants hired to work on the LabVantage Stability module implementation, including the overseeing of script writing, execution, and approval.• Manage budgets for analytical studies (invoicing, purchase orders, change orders)• Manage stability programs by establishing, reviewing, and revising stability protocols.• Maintain stability calendar; monitor and control deliverables, budget and scope.• Author, track, and archive interim and final stability reports for GMP studies.• Utilize SLIM-Stat to conduct stability trend analysis and report OOT in timely manner.• Author drug substance stability sections for regulatory filings.• Conduct scientific assessment for product shelf-life and author memo for approval.• Manage stability related deviations, investigations, OOS, CC, and CAPAs.• Monitor reference standard and critical reagent inventory, stability, and qualifications.• Facilitate cross functional team alignment within and between functions, including CMC, QA, RA, clinical,and development to ensure that the team achieves goals. -
ChemistAlliance Pharma Dec 2011 - Jun 2014Malvern, Pa, Us-Method Development and Validation-Sample receipt and preparation for bioanalytical, agrochemical, and drug metabolism studies (skills include liquid-liquid extraction, solid-phase extraction, tissue homogenization, and plasma protein binding)-Writing and reviewing method development, method validation, and sample analysis reports for biopharmaceutical, bioanalytical, and agrochemical studies-Conduct routine performance verification on HPLC instruments-Assist with changing cell culture medium, preparing cell culture medium, counting cells, and performingcell-based assays-Contribute to company’s business development by attending industry conferences (AAPS, ASMS, WRIB), as well as meet with and present to current/potential clients-Research grant opportunities and help with government proposal preparation
Colleen Pope Skills
Colleen Pope Education Details
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Bob Jones UniversityChemistry
Frequently Asked Questions about Colleen Pope
What company does Colleen Pope work for?
Colleen Pope works for Clarkston Consulting
What is Colleen Pope's role at the current company?
Colleen Pope's current role is LIMS Consultant at Clarkston Consulting.
What is Colleen Pope's email address?
Colleen Pope's email address is cp****@****aco.com
What is Colleen Pope's direct phone number?
Colleen Pope's direct phone number is +181452*****
What schools did Colleen Pope attend?
Colleen Pope attended Bob Jones University.
What skills is Colleen Pope known for?
Colleen Pope has skills like Hplc, Glp, Laboratory, Cell Culture, Analytical Chemistry, Validation, Chemistry, Gmp, Aseptic Technique, Sop, Fda, Lc Ms.
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