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Hello there!Since my earliest memories, I had so many questions about the world. Particularly, I wanted to know how things worked, and to my parents' slight dismay, I took a lot of things apart in the house; a clock and a radio to name a few. I didn't know how to put it back together (Sorry, mom and dad!), nor did I care to, but I will forever be thankful for my parents' patience and encouragement to have had that learning experience.I have since expanded on this young curiosity: I am always itching to know how and why things (tools, processes) work the way they do, and brainstorming ways to put it back together, albeit with a secret personal mission to make it better than it was before. I've come to learn that this involves a balance of disruptive and non-disruptive creativity. And afterwards, I can hardly keep such learnings to myself; I find immense happiness sharing my learnings with those who may not be familiar with said tools or processes!Additionally:• I am a biopharmaceutical professional with 10+ years of progressive experience from scientific research (academia and pharma clinical) and manufacturing operations (clinical and commercial) to CMC Regulatory Affairs.• I enjoy applying process knowledge, analytical abilities, and digestive communication to currently realize the desired future state for key stakeholders. Meticulous while maintaining focus on the big picture, and thrives in a fast-paced environment.• I aspire to embrace leadership roles that use intuitive quality systems and streamlined business processes to encourage personal growth, professional development, continuous improvement, foster collaboration, and ultimately, contribute to the innovation of high quality products that improve life. #OnwardAndUpwardCompetencies:∙ cGXP (cGMP, cGDP, cGLP) ∙ FDA 21 CFR Part 11, 210, 211, 820 ∙ Microsoft Office Suite: Adv. Excel, Word, Powerpoint, PowerApps, Outlook, Powerpoint, Visio, OneNote ∙ Learning Management System: SuccessFactor ∙ Enterprise Content Management: OpenText, Veeva Vault QualityDocs, Veeva Regulatory Vault ∙ Manufacturing Execution Systems: eShopfloor, Citrix, SAP ECC, DeltaV, PAS-X Werum ∙ Trackwise: Global Change, Deviation, and Document Management ∙ Process Analytics: PI Processbook, CFlow Sampler, GraphPad Prism
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Regulatory Affairs ManagerLonzaUnited States -
Manager, Regulatory Cmc Business ManagementBeigene Aug 2023 - PresentCambridge, Ma, UsWork closely with global regulatory CMC leads (small molecules, biologics) to provide project management support in order to meet submission timelines across all relevant markets. Serve as SME for project management tools and Regulatory CMC Veeva systems in addition to creating new or improving existing business operations. -
Biopharm Cmc Regulatory Affairs Project ManagerGsk 2022 - Aug 2023Brentford, Middlesex, Gb• Manage the global CMC regulatory activities for multiple biopharm projects / teams and respond readily to changing events and priorities• Develop strategy and CMC submission documents (Module 3) in the early phase to late phase clinical submissions (IND, IMPD, CTA) in all countries, while assisting marketing applications (MAA, BLA) and post approval activities with key input from technical area SMEs• Advise teams on regulations, guidelines, procedures, and policies relating to the development, registration, and manufacture of new biopharmaceutical products, to expedite submission, review, and approval of global CMC applications• Work in highly matrixed cross-functional project teams, spanning regulatory, biopharmaceutical development, and manufacturing• Innovate by continuously improving departmental ways of working (WoW) as co-chair of WoW meetings• Enhance diversity, equity, and inclusion at work as a DEI champion -
Compliance Operations SpecialistMerck 2018 - 2022• Coordinate multiple document workflows (SOPs, Guidelines, Memos, Batch Records). Author, revise, review, and approve SOPs and Guidelines. Ensure training compliance in alignment with regulatory data integrity guidance. Create and provide training. Provide Right First Time (RFT) metrics and insight to leadership. Establish and perform restricted building access audits, Coaching, mentoring, and teaching interns, coops, and colleagues.• Improve operational efficiencies for validated document management and training management systems and processes through non-disruptive and disruptive means. Evaluate next generation enterprise document repository by testing and providing feedback to the enterprise IT team.• Revitalize departmental quality culture, encourage operational excellence, and support permanent inspection readiness as a key member of the Integrated Compliance Committee• Launch an internal job board at the West Point (WP) site in partnership with the HR organization by leading a cross-functional team of ten• Pilot the first Merck Research Laboratories (MRL) rotation program based on voice survey and design thinking session sponsored by Merck Executive leadership and HR by leading a cross-functional team of six
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Technical Operations EngineerMerck 2015 - 2018• Execute therapeutic protein bulk manufacturing (cGMP), from aseptic vial thaw to 5000L stainless steel bioreactors• Manage shifts of 4 to 6 union contract operators during 12-hour alternating shifts (day and night)• Provide scientific / engineering technical floor support for manufacturing operations, including scheduling, training operators, product disposition, tracking and trending Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), and real-time equipment troubleshooting• Author, revise, and review SOPs and paper batch records• Pre-Approval Inspection (PAI) readiness team member• Author and conduct quality investigations on deviations to determine root cause and assess potential product impact to ensure sterility• Implement corrective and preventative actions to improve product quality and process capability• Coordinate and optimize pure water supply as water skid SME• Develop and refine the new technical operations engineer training program
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Gmp Manufacturing Operations ScientistMerck 2012 - 2015• Execute mammalian cell culture process bulk manufacturing (cGMP Drug Substance), from aseptic cell bank vial thaw up to Single Use 40-layer cell culture stacks• Manage and implement improvement projects through the change control process• Cultural trainer and translator for Merck Durham during site inspection by the South Korean Ministry of Food and Drug Safety (KFDA)• Designed and validated (IQ, OQ, and PQ) the media suite bottle cap opener, resulting in 20% reduction in processing preparation time and significantly reducing ergonomic risk to operators• Execute, troubleshoot, and review electronic batch records• Rectify inventory discrepancies in SAP• Train Cell and Media suite technicians on all manufacturing operations
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Postbaccalaureate Intramural Research Training Award (Irta)National Institutes Of Health 2010 - 2012Bethesda, Md, UsGraduate FellowshipNational Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Malaria and Vector Research (LMVR)Dr. Thomas E. Wellems, MD, PhD• Assist in the development of high throughput flow cytometric assays to accurately detect and measure the growth and viability of human P. falciparum malaria parasites following antimalarial treatment• Manage project timelines and coordinated flow cytometry usage with PATH Malaria Vaccine Initiative Growth Inhibition-Reference Center at the National Institutes of Health• Compiled, analyzed, and presented data to the Laboratory of Malaria and Vector Research (LMVR) -
Research AssistantNorthwestern University 2005 - 2008Evanston, Il, UsWeinberg College of Arts and SciencesDepartment of Neurobiology and PhysiologyDr. Joseph S. Takahashi, PhD (HHMI Investigator)
Michael Han Skills
Michael Han Education Details
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Northwestern UniversityBiology (Biochemistry) -
Hinsdale Central High School
Frequently Asked Questions about Michael Han
What company does Michael Han work for?
Michael Han works for Lonza
What is Michael Han's role at the current company?
Michael Han's current role is Regulatory Affairs Manager.
What is Michael Han's email address?
Michael Han's email address is mi****@****rck.com
What is Michael Han's direct phone number?
Michael Han's direct phone number is +163084*****
What schools did Michael Han attend?
Michael Han attended Northwestern University, Hinsdale Central High School.
What skills is Michael Han known for?
Michael Han has skills like Molecular Biology, Cell, Infectious Diseases, Laboratory, Cell Culture, Research, Pcr, Western Blotting, Biochemistry, Lifesciences, Microscopy, Cell Biology.
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