QUALIFICATIONS / EXPERIENCE:
● BSc, MSc or PhD with relevant pharmaceutical research and development experience
● At least 3 years of industrial bioanalytical experience, ideally within pharma and biotech. GLP experience is a plus.
● Solid knowledge of LBA methods (PK/ADA). LC-MS experience in large molecule bioanalysis is a plus
● Strong hands-on abilities to independently develop bioanalytical solutions and troubleshoot
● Willingness to analyze bioanalytical samples in the timely fashion when needed.
● Basic knowledge of bioanalytical sample workflow for in-life studies.
● Familiar with the ADME and PK/PD experiments is a plus
● Proficient in English and comfortable working in a bilingual environment (English and Chinese, mainly in English)

RESPONSIBILITIES / DUTIES:
● Independently manage the bioanalytical aspects of multiple assigned projects by providing end-to-end support to internal project teams and directing bioanalytical work at CROs for assay transfer and troubleshooting if needed.
o Manage the development, transfer, qualification and technical leadership in issue resolution of specific and sensitive bioanalytical methods required for the discovery and development compound (drug), anti-drug antibodies (ADA) and soluble targets in the given project.
o Manage and conduct the in-house sample analysis and deliver qualified data to internal stakeholders in a timely manner.
o Participate in the laboratory operations such as matrix, reagents and consumable materials procurement and maintenance, etc.
● Support and co-develop PK/PD/ADA analytical strategies (e.g. technology, assays, matrices, sample collection)
● Improve and optimize laboratory workflows independently and creatively
● Ensure relevant compliance with the current global and local bioanalytical guidelines and GxPs.

KEYWORDS:
Assay development, GLP, Method qualification, Sample Analysis, Ligand Binding Assay, PK, ADA, PD biomarker