Michael Han Email & Phone Number

United States

Cambridge, Ma, Us

Work 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.

Brentford, 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

• 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

• 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

• 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

Bethesda, Md, Us

Graduate 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)

Evanston, Il, Us

Weinberg College of Arts and SciencesDepartment of Neurobiology and PhysiologyDr. Joseph S. Takahashi, PhD (HHMI Investigator)

Bachelor Of Arts (Ba), Biology (Biochemistry)

Education record