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I have hands-on experience in LC-MS/MS method development, validation, and regulatory compliance. I've worked on both Non-GLP and GLP studies with all of my studies passing FDA and regulatory audits. I'm skilled with Sciex and Agilent LC-MS/MS platforms and enjoy collaborating across teams to solve technical challenges and deliver high-quality data. I'm now looking to bring my problem-solving skills and scientific rigor to a new opportunity where I can continue growing and making an impact.

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.


  拥有8年以上DMPK和生物分析相关经验，覆盖科研机构、甲方研发团队及跨国CRO环境。现任 Pharmaron UK高级科学家，承担DMPK和生物分析Study Lead职责，精通GLP/GCP体系下LC-MS/MS方法开发与验证、ADME试验PK/TK数据整理和解读，丰富的IND-enabling阶段项目支持及和FDA沟通和答疑的经验。
  能够在early discovery阶段与药化、药理、毒理及项目团队紧密协作，把活性靶点、SAR、体外ADME、体内PK/TK和暴露数据转化为可执行的DMPK策略，支持化合物优化、候选化合物筛选、Go/No-Go判断及PCC推进。
  熟悉IND-enabling阶段的DMPK/TK研究逻辑、GLP数据质量要求、CRO交付管理、研究方案/报告审核及申报资料准备，已经独立完成多个IND资料中DMPK相关章节的撰写（2.4.3、2.6和M4板块）、审阅和问题答疑。
  具备丰富的客户沟通、项目优先级管理、跨部门协作、技术问题排查和团队指导经验，可作为客户、项目经理、BD、in life团队、DMPK、毒理、CMC及注册相关团队之间的技术接口，同时推动多个项目在有限时间内高质量交付。



  Biophrmaceutical &Bioanalytical & Clinical research mangement Expert
  Experienced vice president with over 20 years of experience in Clinical research in CRO and Pharmaceutical. Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements. Consistently saved costs while increasing profits.. Possess unique set of knowledge and skills which includes in-depth understanding of business processes, business development and operational management at floor and strategic level.
  2000 plus methods expert in critical (low Pg,stabiity issue, chiral ,derivitisation)and Large Molecules MAb and in-vitro.
  Handled more than 100000 billable samples with Method and validation activities by using 36 LC-MS/MS/108 staff.
  Lab setup Lambda Ahmedabad,Lambada Canada,Panexcell.
  Set up for typical formulation e.g. Injectables,Inhalers,Transdermal patches,Ointments & Creams, critical study for safety Fingolimid


Ruei-Lin Wu

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Pharmacist

Regulatory Affairs Specialist (pharmacist)

Pharmacist

Research assistant

Education

Master of Clinical Pharmacy -

Doctor of Pharmacy -

Skills

Timeline

Pharmacist

Regulatory Affairs Specialist (pharmacist)

Pharmacist

Research assistant

Master of Clinical Pharmacy -

Doctor of Pharmacy -

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