Mingchien Li, PhD
Miaoli
Summary
10+ years analytical MSAT & quality experience in pharmaceutical industry (including FDA/ EMA approved CGMP facilities) for small molecule and biologics (mAb, plasmid, mRNA and viral vector) in solid and injectable dosage forms. Successfully support analytical readiness of five product transfers, one 505(b)(2) and one ANDA submissions as MSAT/QC; support for BLA approval and FDA PLI in 2021 as QA.
Overview
11
11
years of professional experience
Work History
Associate Director of Analytical Development & QC
GeneFab
11.2022 - Current
- Lead analytical testing for technical platform development and batch release for plasmids, mRNA, lipid nano particles and viral vectors, mainly includes ELISA (dsRNA, HCP, capsid titer), qPCR (genomic titer), cell based assay (infectious titer, mRNA potency, ex: Cas9, eGFP), CE (mRNA integrity, cap efficiency, polyA length), HPLC (lipid contents), endotoxin and mycoplasma.
- Successfully developed CE-based methods, including Poly A tail length determination, large mRNA (> 12,000 nts) size and integrity determination, and residual mRNA content in plasmid.
- Co-developed a cell-based assay for CRISPR-Cas9 mRNA editing efficiency evaluation.
Associate Manager of Quality Assurance
PharmaEssentia Corporation
01.2021 - 06.2022
- Lead QA group (team of 10) responsible for QA oversight of GMP activities in Taichung plant and CMOs (in USA and Germany) for biological drug substance , drug product (pre-filled syringes and injection pen), packaging and labeling.
- Support first product launch to US market as QA to ensure product quality and compliance.
- QA host/SME of FDA Pre Licensing Inspection in Sep 2021.
- Coordinate changes between business partners in support of regulatory variations submissions (type IA, IB, type II, AR, CBE-0, CBE-30, PAS) to ensure supply continuity in EU and US markets.
- Improve quality system work flow and effectiveness including deviation/lab investigation and change control module.
Principal Scientist
TaiMed Biologics
12.2019 - 01.2021
- As main scientific liaison for analytical method transfers to contract lab in Europe.
- Served as SME to author and review myriad of technical documents, including: analytical comparability study in response to requirement from FDA for site change, analytical method qualification strategies and related SOPs/ protocols/ reports, risk assessments in response to CAPA and lab investigations, QC related SOPs, test methods and test records.
- Participated in BLA revision for post approval submission
Associate Manager/ Manager of MSAT-analytical
Bora Pharmaceuticals
06.2014 - 12.2018
- Progressed in roles with growing responsibility and job scope from Scientist (starting from Jun 2014), to Associate Manager (Mar 2015), and to Manager (Mar 2018) within 4 years.
- Established and led a dynamic team—including 4 to 13 chemists and scientists—with continued mentorship and routine performance evaluation.
- Directed all daily activities, short- and long-term initiative to ensure cGMP conformance and adherence to missions.
- Led the analytical readiness for five product transfers (post approval changes), one 505(b)(2) and one ANDA submission—including 120+ method qualifications, specification and method creations, batch release and stability tracking.
- Designed and led regulatory required study—in-use stability, elemental impurity assessment, split tablet study, multimedia dissolution, case C (dose dumping) study.
- Spearheaded lab investigations and CAPA installations.
- Operated as a primary contact and main liaison for progress updates and communication to project-based crossed-functional teams.
Education
Ph.D. - Analytical Chemistry
Texas A&M University
College Station, TX, USA05.2012
Skills
- Phase appropriate analytical method qualification
- Analytical assays for small molecule and biologics including ELISA based (HCP, dsRNA, capsid titer); qPCR/dPCR based (HCDNA, residual plasmid, infectious titer); CE based (mRNA size & integrity, capping efficiency; LC based (%content and impurity); Others (endotoxin, mycoplasma)
- Analytical method transfer from RD to CGMP, between sites and external labs
- Knowledge and experience in GxP operation per product lifecycle and regulatory requirements (CMC, Type IA/ IB/ II/ AR, CBE-0/30C, PAS) and standards (USP/EP, PIC/S, ICH)
Publications
- "Fluorescent pI Markers for Isoelectric Focusing Separations and Fluorescent Labeling", G Vigh, M Li, US Patent App. 15/633,331
- "Overcoming the aggregation problem: A new type of fluorescent ligand for ConA-based glucose sensing", BM Cummins, M Li, AK Locke, DJS Birch, G Vigh, GL Coté, Biosensors and Bioelectronics 63, 53-60
Timeline
Associate Director of Analytical Development & QC
GeneFab
11.2022 - Current
Associate Manager of Quality Assurance
PharmaEssentia Corporation
01.2021 - 06.2022
Principal Scientist
TaiMed Biologics
12.2019 - 01.2021
Associate Manager/ Manager of MSAT-analytical
Bora Pharmaceuticals
06.2014 - 12.2018
Ph.D. - Analytical Chemistry
Texas A&M University
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