Miaoyu Li
Summary
- Bioanalytical Project Lead with 8 years+ of experience in LC–MS bioanalysis and DMPK across research institutes, sponsor-side, and multinational pharmaceutical environments. Proven ability to deliver high-quality studies under GLP and non-GLP settings, with end-to-end ownership from study design and method development/validation to sample analysis, data review, and compliant final reporting.
- Extensive experience in small molecule and peptide (in vitro/in vivo) programs, supporting projects from early discovery through IND-enabling and clinical stages. Strong expertise in integrated ADME/DMPK strategy design, PK analysis, dose prediction, and therapeutic window assessment.
- KPI-driven with solid operational planning and resource optimization capability, ensuring right-first-time delivery and high instrument utilization. Proficient in SCIEX 5500/6500+, ZenoTOF 7600, Thermo Q Exactive HF-X, laboratory automation platforms (Tecan D300e, Agilent Bravo), and Phoenix WinNonlin.
Overview
9
9
years of professional experience
5
5
years of post-secondary education
Work history
Senior Scientist
Pharmaron UK
Hoddesdon
2023.11 - 2026.03
- Lead and coach a team in the successful delivery of multiple strategic client projects within a CRO environment, overseeing critical process milestones to ensure right-first-time execution, high data quality, and on-time study completion.
- Assume full end-to-end accountability for project management, from study design and planning through method development/validation, sample analysis, data review, and issuance of compliant final reports.
- Coordinate cross-functional activities across bioanalysis, DMPK, and in-life teams, aligning sampling schedules, deliverables, and key timelines to ensure efficient study progression and proactive risk mitigation.
- Manage workload prioritisation based on study urgency and technical complexity, optimising team capacity and instrument utilisation to maintain high throughput while safeguarding data integrity and regulatory compliance.
- Supervise troubleshooting of complex LC–MS/MS platform issues (triple quadrupole and ZenoTOF), minimising downtime and ensuring business continuity, while strengthening team technical capability through structured guidance.
- Maintain direct communication with clients and internal stakeholders, providing transparent progress updates, risk assessments, and scientifically sound recommendations to support decision-making.
- Conduct and review PK analysis using Phoenix WinNonlin, ensuring accurate interpretation and clear communication of results to inform project strategy.
- Achievements:
- Strengthen the organisation’s PK decision-making capability by leading the generation, critical evaluation, and scientific interpretation of high-quality bioanalytical data, enabling data-driven dose optimisation and formulation strategy refinement across multiple development programs.
- Drive long-term client retention and repeat business by establishing a reputation for scientific rigour, delivery reliability, and proactive risk management.
- Re-engineer bioanalytical workflows and integrate laboratory automation (Tecan D300e, Agilent Bravo), reducing end-to-end study turnaround time (method setup to final report) to 2 days for most projects, significantly improving operational efficiency and platform capacity.
- Strategically expand peptide bioanalysis capability by aligning MS platform selection (SCIEX 6500, ZenoTOF 7600) with project needs and optimizing assay performance to reduce matrix interference and enhance sensitivity, positioning the team to support more complex peptide pipelines.
Bioanalysis/DMPK Project Lead
Micot Technology Co., Ltd
Xi'an
2021.01 - 2022.08
- Took ownership of analytical method development and validation for small molecules, peptides, and biologics, leading assay strategy design to support both in vivo and in vitro PK studies in close collaboration with pharmacology and medicinal chemistry teams.
- Directed outsourced in vitro studies through effective CRO oversight (including large-molecule programs), ensuring scientifically sound deliverables, on-time completion, and fully compliant documentation standards.
- Led PK/TK data analysis and interpretation, authored and reviewed study protocols and reports, and provided clinically relevant PK parameters to support translational and clinical decision-making.
- Contributed to U.S. FDA IND submissions by preparing pharmacokinetic documentation, including bioanalytical in vivo PK sections and ADME/DDI components, as well as drafting analytical CMC-related regulatory materials.
- Drove resolution of complex analytical challenges, including degradation investigations and development of novel analytical approaches for large molecules to enhance assay robustness and scientific reliability.
- Achievements:
- Phase I clinical trial: XXXX IND pharmacokinetic documents writing.
- Phase II clinical trial: XXXX pre-IND pharmacokinetic documents writing.
- XXXXX IND pharmacokinetic documents writing.
Responsible Technician, GLP Bioanalysis
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Shanghai
2017.02 - 2020.12
- Independently conducted extensive PK analysis using Phoenix WinNonlin, generating and interpreting key PK parameters (AUC, Cmax, Tmax, CL, Vd, T1/2, MRT, bioavailability).
- Developed strong mechanistic understanding of PK parameter interrelationships, enabling scientific interpretation of clearance trends, dose predictions, accumulation and exposure-response patterns.
- Evaluated atypical PK profiles and investigated potential causes (analytical, formulation, metabolism-related), providing scientific rationale for study teams.
- Performed LC–MS/MS quantitative bioanalysis under a GLP quality system, following SOPs and maintaining clear traceability and controlled records.
- Processed and reviewed data using analyst software; managed sample tracking and reporting workflows through Watson LIMS.
- Wrote finding reports for rejected batches, instrument issues, or workflow deviations, including impact assessment on data quality and timelines. Produced detailed audit responses following QA feedback, with evidence-based explanations and preventative actions.
- Supported method transfer across platforms, selecting instruments based on compound properties and platform sensitivity differences.
- Supported instrument qualification activities (3Q validation) with IT team; ensured instruments were used only in an approved, qualified state.
- Achievements:
- Supported 20+ TK/PK programmes contributing to preclinical candidate advancement toward Phase I clinical trials in the US and China.
- Generated and interpreted PK data for >30,000 biological samples, developing strong expertise in exposure analysis and dose-related PK parameters.
Education
MSc - Pharmacology and Drug Development
Hull York Medical School
2022.09 - 2023.08
BSc - Pharmacy
Xi'an Medical University
2013.09 - 2017.07
Skills
- Mentor and coach junior scientist
- Extensive experience with UPLC, HPLC, LC–MS/MS and GC for drug substance and drug product analysis
- Subject Matter Expert (SME) in analytical method development, validation, optimisation and transfer, ensuring compliance with ICH, EMA and FDA guidelines
- Advanced analytical data interpretation with strong capability in troubleshooting
- Lead author and reviewer of analytical protocols, validation reports, technical documentation and SOPs
- IND-enabling DMPK documentation writing
- Independent PK/TK analysis (Phoenix WinNonlin) and integrated ADME/DMPK strategy support
- Cross-functional matrix collaboration
- Excellent written and verbal communication skills, confident in presenting scientific results to internal teams and external clients
- Automation and workflow improvement (Tecan D300e, Agilent Bravo)
LANGUAGES
English (Fluent)
Chinese (Mandarin) (Native)
Timeline
Senior Scientist
Pharmaron UK
2023.11 - 2026.03
MSc - Pharmacology and Drug Development
Hull York Medical School
2022.09 - 2023.08
Bioanalysis/DMPK Project Lead
Micot Technology Co., Ltd
2021.01 - 2022.08
Responsible Technician, GLP Bioanalysis
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
2017.02 - 2020.12
BSc - Pharmacy
Xi'an Medical University
2013.09 - 2017.07