LM Bioanalytical Scientist Full-time

LM Bioanalytical Scientist

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The Position

For Pharmaceutical Sciences at the China Innovation Center of Roche (CICoR), we are looking for an individual contributor as a Bioanalytical Scientist (BAS). The major mission of BAS is to achieve scientific excellence in Bioanalysis for Large Molecules, including assay development from scratch, conducting assay qualification, sample analysis by request and transferring the assay to external vendors. Additionally, the BAS will maintain a close relationship to global Bioanalytical Sciences groups in BioX – Bioanalytics and Biomarker Chapter.

Qualifications / Experience:

• MSc or PhD with relevant pharmaceutical research and development experience
• At least 5 years of industrial bioanalytical experience, ideally within pharma and biotech. GLP experience is a plus.
• Solid knowledge of LBA methods (PK and ADA). LC-MS experience in large molecule bioanalysis is a plus
• Strong hands-on abilities to independently develop bioanalytical solutions and troubleshoot for PK and ADA assays
• 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.
• 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.
• Manage and conduct the in-house sample analysis and deliver qualified data to internal stakeholders in a timely manner.
• Participate in the laboratory operations such as matrix, reagents and consumable materials procurement and maintenance, etc.
• Good communication with key stakeholders, such as DMPK, Toxicology expertise and CROs.
• 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.
• This position is mainly laboratory-based duty.

Keywords:

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