Jihong W.
Analytical and QC consultant
Experience
Aug 2025 - Present
4 monthsRockville, United States
Analytical and QC consultant
JHW CMC Consulting LLC
Sep 2019 - Aug 2025
6 yearsRockville, United States
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Amgen
- Maintain clinical and commercial supplies for legacy Horizon projects and transfer them into the Amgen network, including site evaluation and selections, analytical method transfer to process development and commercial QC labs.
- Support knowledge transfer to Attribute Sciences and Product Quality teams to ensure smooth transition for critical reagents, specifications, and stability programs.
- Move and set up the development lab in Rockville to align with Amgen infrastructure to support R&D for early candidate selections and assessments.
- Plan and establish the CMC lab, build the analytical science team with mass spectrometry and cell-based bioassay capabilities, and develop and implement analytical procedures and guidance documents.
- Lead the development, qualification, and bridging of all analytical methods in-house and in collaboration with CDMOs and CROs, including physicochemical assays (HPLC, CE-SDS, cIEF, glycan, LC-MS), bioassays, residual testing, and tech transfer of molecules from development to post-market.
- Collaborate with CDMOs and the internal DS/DP site in Ireland on production, process characterization testing, lot release, in-process testing, and stability studies for all products.
- Guide stage-appropriate protein characterization and CQA determination, manage reference standard characterizations, comparability studies, specification setting, and stability studies, including shelf-life extensions.
- Author and review CMC global regulatory filings for IND, IMPD, BLA; address agency questions and lead global BLA filing of Uplizna, including method transfers to Japan and China.
- Provide analytical support for in-house R&D, process development, and formulation development, achieving development from clone selection to IND in one year.
- Collaborate with IT to establish CMC lab infrastructure, including eLN, SharePoint sites, shared drives, and data processing platforms (Empower 3, Chromeleon, Biopharma Finder).
- Maintain critical reagents, including cell banks, reference standards, assay controls, and assay standards.
Aug 2004 - Sep 2019
15 years 2 monthsGaithersburg, United States
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AstraZeneca/MedImmune
- Lead late-stage protein characterization and biophysics team of 15 scientists to perform gap analysis of late-stage projects; design experiments and review results to identify peaks in lot release and key assays (SEC, gel electrophoresis, IEC/cIEF, RP-HPLC, oligosaccharide profiling, peptide mapping, intact mass).
- Provide strategies for determination of degradation pathways during manufacturing, storage, and stressed conditions; verify CQAs by enrichment/fractionation of variants or impurities and study structure-function relationships; develop and optimize assays as needed.
- Support higher-order structure and particle characterization.
- Serve as analytical lead for Moxetumomab Pasudotox (BLA approved 2018) and major author of BLAs for durvalumab, benralizumab, tremelimumab, anifrolumab, tralokinumab; address regulatory questions and draft agency responses for INDs, IMPDs, BLAs.
- Lead characterization of novel protein and protein vaccine projects including monosaccharide composition analysis, oligosaccharide profiling, sialic acid quantitation, glycation site determination, N-terminal sequencing, reducing peptide mapping, AAA to support drug candidate research.
- Oversee analytical development of MedImmune ADC program: assay development (HIC, drug-related impurities by RP-HPLC), coordinate tech transfers, set up lot release assays and stability protocols, perform characterization assays, authorize IND.
- Support troubleshooting and characterization of commercial drug products (Synagis, Imfinzi, Fasenra, Lumoxiti).
- Collaborate with upstream/downstream process groups and formulation colleagues for in-process characterization and troubleshooting (protein reduction, aggregates, particles, fragmentation, oligosaccharide profile changes, HCP).
- Support research on novel platform molecule engineering (ADC, bispecific IgGs, DuetMab) by LC-MS.
- Manage chromatography group for in-process testing (A280, AAA, RP-HPLC, Protein A bindable, Protein L, cholesterol, PEG, Tween-80), oversee method development for IEC, RP-HPLC, vitamin analysis, Pluronic 68, develop UPLC AAA method for cell culture samples with shorter run time.
- Participate in due diligence on analytical data review (Spirogen acquisition).
- Provide guidance for SME teams on mass spectrometry, biophysics, glycosylation.
- Write/review SOPs, development reports, validation reports; participate in PQE investigations.
- Work with scientific writing and regulatory science groups to standardize IND/IMPD filing figures and templates; author/review multiple IND/IMPD amendments annually; collaborate with QA/QC on OOS and CAPA investigations to ensure safe release of clinical materials.
Jan 2003 - Aug 2004
1 year 8 monthsWoburn, United States
Senior Scientist
VisEn Medical, Inc.
- Developed analytical assays for 50+ oncology proteases, enhancing imaging reagent specificity.
Jan 1999 - Jan 2003
4 years 1 monthMedford, United States
Senior Scientist
Consensus Pharmaceuticals, Inc.
- Led peptide synthesis/sequencing and analytical screening, optimizing drug candidate selection.
Summary
- Experienced analytical science leader with 20+ years in biologics development in both large pharma and startup biotech
- Specialized in cutting-edge analytical method development (UPLC, MAM, AI-driven data analysis), protein characterization, and CQA assessment
- Extensive experience in authoring regulatory submissions and interaction with agencies with proven success record of 20+ IND and 5 BLA for mAbs, bispecifics, ADCs, and fusion protein
- Establish lab from scratch. Method transfer, qualification and validation with global CDMOs.
- Build and develop high performing teams.
- Complex problem solving. Pioneered automation and machine learning in analytical workflows.
Languages
English
NativeChinese
ElementaryEducation
Rutgers, The State University of New Jersey, New Brunswick
Ph.D. · Chemistry · New Brunswick, United States
University of Science and Technology of China
B.S. · Chemistry · Hefei, China
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