Melissa Hill-Drzewi
Senior Scientist at Celldex Therapeutics- Claim this Profile
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Bio
Experience
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Celldex Therapeutics
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United States
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Biotechnology Research
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100 - 200 Employee
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Senior Scientist
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Apr 2023 - Present
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Frequency Therapeutics
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United States
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Biotechnology Research
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1 - 100 Employee
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Senior Quality Assurance Manager
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Oct 2021 - Mar 2023
• Manage and administer GxP Document Management System and Part 11 DocuSign in accordance with Regulatory and Quality requirements. • Review, maintain, and own documentation to support early and late-phase clinical development and commercial approval of drug products. • Establish and lead training curricula across GxP functional areas.
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Senior Scientist II/Lab Operations
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Mar 2020 - Oct 2021
•Execute assays to support identification of optimal small molecule combinations for hearing program. • Support invention claims/patent filings, grants, technical reports, Investigational New Drug (IND) filings, and licensing agreements. • Manage lab operations, including but not limited to: training and oversight of Environmental, Health, and Safety (EH&S) program, Chemical Hygiene Plan (Chemical Hygiene Officer (CHO)), Mouse Breeding Colony, compliance with Institutional Animal Care and… Show more •Execute assays to support identification of optimal small molecule combinations for hearing program. • Support invention claims/patent filings, grants, technical reports, Investigational New Drug (IND) filings, and licensing agreements. • Manage lab operations, including but not limited to: training and oversight of Environmental, Health, and Safety (EH&S) program, Chemical Hygiene Plan (Chemical Hygiene Officer (CHO)), Mouse Breeding Colony, compliance with Institutional Animal Care and Use Committee (IACUC), COVID Response Site Head. • Implemented use of electronic laboratory notebooks (ELNs) across Research and Development at two sites. Administer, support, train, review, audit, and report compliance statistics. • Established Lab Information Management System (LIMS). Develop, implement, and continuously improve features within and integrating to LIMS, including but not limited to entity type registration, inventory, data analysis, workflows. Serve as LIMS Administrator. o Implemented data analysis tools to generate 8 plots for 4 concentration response curves in 3 minutes or less versus 2 hours manually-representing a 97.5% time- savings.
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Senior Scientist I, Scientist II, Research Scientist
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Nov 2015 - Mar 2020
• Instituted drug discovery labs with equipment and automation necessary for small molecule screening. • Established, optimized, and miniaturized three-dimensional primary cell proliferation assays to identify drug candidates for hearing program. o Flow to imaging assay format change reduced manual labor of processing 96-wells by 87.5% (120 minutes to 15 minutes) and data acquisition time by 75% (2 hours to 30 minutes). • Developed primary cell cytotoxicity assay to establish insight… Show more • Instituted drug discovery labs with equipment and automation necessary for small molecule screening. • Established, optimized, and miniaturized three-dimensional primary cell proliferation assays to identify drug candidates for hearing program. o Flow to imaging assay format change reduced manual labor of processing 96-wells by 87.5% (120 minutes to 15 minutes) and data acquisition time by 75% (2 hours to 30 minutes). • Developed primary cell cytotoxicity assay to establish insight into therapeutic window.
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Bristol Myers Squibb
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Research Scientist I
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Oct 2011 - Nov 2015
•Member of Lead Evaluation Team which develops and executes cell-based assays to enable lead identification/optimization. •Member of Lead Evaluation Team which develops and executes cell-based assays to enable lead identification/optimization.
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Boehringer Ingelheim
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Germany
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Pharmaceutical Manufacturing
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700 & Above Employee
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Scientist III
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Jan 2006 - Oct 2011
•Generated weekly SAR-driving data for various projects in Lead Initialization/Lead Optimization stages and developed/optimized supplementary assays for these projects. •Generated weekly SAR-driving data for various projects in Lead Initialization/Lead Optimization stages and developed/optimized supplementary assays for these projects.
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CGI Pharmaceuticals, Inc.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Research Associate II, Senior Research Associate, Senior Research Associate II
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Jul 2002 - Jan 2006
•Core-instituting member of High-Throughput Screening (HTS) division. Responsible for initial testing of small molecule drug candidates through kinase programs to help discover breakthrough therapeutics for multiple oncology and allergy/autoimmune/inflammatory disease indications. •Core-instituting member of High-Throughput Screening (HTS) division. Responsible for initial testing of small molecule drug candidates through kinase programs to help discover breakthrough therapeutics for multiple oncology and allergy/autoimmune/inflammatory disease indications.
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Neurogen Corporation
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Biotechnology Research
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1 - 100 Employee
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Intern, Research Assistant, Research Associate I
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Feb 1999 - Jul 2002
•Tested small molecule drug candidates through a number of different drug targets/programs to help discover biologically active drug candidates. •Tested small molecule drug candidates through a number of different drug targets/programs to help discover biologically active drug candidates.
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Education
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Southern Connecticut State University
Double Baccalaureate, Biology and Chemistry