Miaoyu Li
HODDESDON,Hertfordshire
Summary
LC-MS/MS bioanalyst with around eight years' experience in CRO and GLP environments. Take ownership of delivery from proposal to method development, method validation, sample analysis, data review and final reporting. Work closely with in-life teams to align sampling, deliverables and timelines. Hands-on across SCIEX 5500/6500+ and ZenoTOF 7600, and Thermo Q Exactive HF-X. Experience includes small-molecule and peptide in vivo and in vitro work; workflow automation (Tecan D300e, Agilent Bravo) in both regulated and non-regulated environments; and in-depth knowledge of PK/TK analysis using 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 - 2026.02
- Lead multiple client studies in a CRO environment, taking ownership from method optimisation to sample analysis, data review, and final reporting.
- Run LC-MS/MS quantitative assays to support discovery DMPK work, keeping turnaround tight while maintaining consistent data and traceable records.
- Prepare study documentation and deliverables (e.g., study protocol, results summaries, final reports) aligned with internal SOP and client requirements.
- Troubleshoot LC-MS/MS systems (triple quadrupole/ZenoTOF) to restart quickly and reduce downtime; record issues and resolutions clearly.
- Provide clear technical updates, risks and results to clients and internal in-life groups and keep reporting aligned to client expectations.
- Complete Phoenix WinNonlin PK analysis to support reporting and client decision-making.
- Achievements:
- Shorten the end-to-end turnaround (method setup to final report) down to about two days for most studies by streamlining workflow and building automation steps (Tecan D300e, Agilent Bravo).
- Helped build team capability by training colleagues to complete PK analysis and consistent data delivery.
- Expanded peptide method capability by appropriate MS platforms (e.g., Sciex 6500/7600) and optimising for less interference and better sensitivity.
Researcher, Pharmacokinetics
Micot Technology Co., Ltd
Xi'an
2021.01 - 2022.08
- Designed and supported in vivo and in vitro PK experiments for small molecules and peptides, working closely with pharmacology and synthesis teams.
- Managed outsourced in vitro work through CROs (including large molecule projects), ensuring deliverables were accurate, on time, and well-documented.
- Conducted PK/TK analysis and interpretation; prepared and reviewed protocols/reports and provided PK parameters to clinical teams.
- Contributed to IND pharmacokinetic material submission for the FDA, including in-vivo PK (bioanalytical section) and ADME/DDI sections.
- Achievements:
- Phase I clinical trial: XXXX IND pharmacokinetic documents writing.
- Phase II clinical trial: XXXX pre-IND pharmacokinetic Chinese 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
- Performed LC-MS/MS quantitative bioanalysis under a GLP quality system, following SOPs and maintaining clear traceability and controlled records.
- Supported high-throughput TK/PK sample analysis, including human plasma and clinical sample workflows.
- Processed and reviewed data using analyst software; managed sample tracking and reporting workflows through Watson LIMS.
- Supported QA audits and inspections through complete documentation and good audit trail awareness in electronic systems.
- Wrote finding reports for rejected batches, instrument issues, or workflow deviations, including assessment of data quality and timelines.
- Supported instrument qualification activities (3Q validation) with IT team.
- Achievements:
- Supported 10+ quantitative methods; delivered 20+ TK/PK projects and processed around 30,000 biological samples.
- Supported preclinical studies progressing toward Phase I clinical development in the US and China.
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
- LC-MS/MS quantitative bioanalysis (small molecules and peptides) on triple quadrupole and HRMS platforms (SCIEX 5500/6500, ZenoTOF 7600; Thermo Q Exactive HF-X) with LC systems (Agilent, Thermo, Shimadzu)
- Proficient in the use of relevant software, eg, Analyst, SCIEX OS, Xcalibur, Watson LIMS
- Phoenix WinNonlin PK/TK analysis
- Method development and validation
- Regulated documentation and data integrity (GLP/GxP; traceability and audit trail) Batch review, deviations, investigations and assessment
- Write bioanalytical reports and pharmacokinetic sections of IND submissions efficiently and accurately
- Automation and workflow improvement (Tecan D300e, Agilent Bravo)
- Mentoring and cross-functional working (including in-vitro and in-life groups)
LANGUAGES
English (Fluent)
Chinese (Mandarin) (Native)
Timeline
Senior Scientist
Pharmaron UK
2023.11 - 2026.02
MSc - Pharmacology and Drug Development
Hull York Medical School
2022.09 - 2023.08
Researcher, Pharmacokinetics
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