Michael Zaleski Email and Phone Number
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I am a scientist and engineer with a unique combination of skills in pharmaceutical development, cGMP manufacturing, and regulatory affairs. I have 5 years’ experience leading translational research projects in academic labs and 2 years’ experience as an engineer in cGMP manufacturing.I’ve been involved in almost every phase of the pharmaceutical development process, from preclinical formulation development to commercial manufacturing. My main expertise is in CMC (Chemistry, Manufacturing, and Controls), including formulation development, process development, analytical chemistry, and regulatory. I aspire to use these skills to develop new medicines efficiently and safely.
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Senior Scientist, Vaccine Drug Product DevelopmentMerck Aug 2024 - PresentWest Point, Pennsylvania -
Phd CandidateUniversity Of Pennsylvania Aug 2020 - Aug 2024Philadelphia, Pennsylvania, United States -
Intern, Regulatory CmcMerck Jun 2023 - Aug 2023Upper Gwynedd, Pennsylvania, United States• Gathered regulatory intelligence for Cell and Gene Therapy Products (CGTPs) by synthesizing information from regulatory approvals for CGTPs, regulatory guidances, and scientific literature.• Communicated findings to the Regulatory CMC team via multiple oral presentations to inform projects in preclinical development.
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Research SpecialistPenn Medicine, University Of Pennsylvania Health System Sep 2018 - Aug 2020Greater Philadelphia AreaManaged a research project sponsored by a biopharmaceutical company, with the goal of developing nanoparticles to treat acute lung inflammation.• Led weekly team meetings, consisting of 5+ scientists, to prioritize tasks, allocate resources, and ensure project remained on-schedule. Communicated project updates in monthly meetings with key stakeholders. • Developed formulations and manufacturing processes to stably load 5 small molecule drugs into lipid nanoparticles and conjugate biologics to the nanoparticle surface.• Developed high-throughput mouse models of acute lung inflammation, enabling our team to test the in vivo efficacy of 15+ liposome nanoparticle formulations. • Developed proficiency in numerous analytical methods for testing nanoparticles and biologics, including HPLC, LC-MS/MS, DSC (Differential Scanning Calorimetry), DLS (Dynamic Light Scattering), and NTA (Nanoparticle Tracking Analysis). -
Process EngineerKymanox Jun 2017 - Aug 2018Raleigh-Durham, North Carolina AreaI provided clients in the pharmaceutical, biotech, and medical device industries with engineering and project management support. Notable projects include:• Supported the commercial launch of a combination product (pharmaceutical drug + medical device). I primarily worked on serialization implementation, design control documentation, and change management.• Project management of a serialization implementation project, to enable our client to meet regulatory requirements for serialization (i.e., DSCSA). I led the integration of our client's cloud-based serialization system with over 7 trade partners (CMOs, CPOs, and 3PLs), then authored and executed Computer Systems Validation documentation. -
Associate Process EngineerKymanox Jul 2016 - Jun 2017Raleigh-Durham, North Carolina Area• Filled the role of plant engineer for a sterile pharmaceutical manufacturing plant. Provided engineering and maintenance support for automated aseptic syringe filling machines and automated syringe labeling machines.• Authored and executed qualification protocols (IQ, OQ, PQ) for a cold storage room. Assisted with gap assessment and reprogramming of a custom control system for HVAC units that were initially unable to meet specifications.• Delivered technical writing and deviation investigation support for a biotechnology client to ensure a successful PAI (FDA Pre-Approval Inspection)• Generated and executed qualification protocols for process equipment as part of a pharmaceutical manufacturing expansion project. • Completed commissioning and turn over packages for new equipment, facilities, and utilities to ensure our client’s expectations and requirements were met. Worked with vendors to fill gaps as needed.
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Manufacturing Technology Engineer - InternThe Chemours Company May 2015 - Aug 2015Deepwater, New Jersey
Michael Zaleski Skills
Michael Zaleski Education Details
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Pharmacology
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Chemical Engineering
Frequently Asked Questions about Michael Zaleski
What company does Michael Zaleski work for?
Michael Zaleski works for Merck
What is Michael Zaleski's role at the current company?
Michael Zaleski's current role is Formulation Development | Pharmaceutical Sciences.
What is Michael Zaleski's email address?
Michael Zaleski's email address is mz****@****enn.edu
What is Michael Zaleski's direct phone number?
Michael Zaleski's direct phone number is +130277*****
What schools did Michael Zaleski attend?
Michael Zaleski attended University Of Pennsylvania, University Of Notre Dame.
What skills is Michael Zaleski known for?
Michael Zaleski has skills like Microsoft Office, Matlab, Aspen Plus, Chemical Engineering.
Who are Michael Zaleski's colleagues?
Michael Zaleski's colleagues are Judy Mazzolani, Setthat Likitchatpakdee, Jonathan Morales, Trina Booker, Eladio Ruipérez, Jean Ramirez, Paul D'alesandro.
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Michael Zaleski
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