· 公司：上海罗氏制药有限公司　

· 职位：大分子生物分析科学家 LM Bioanalytical Scientist

· 地点：浦东新区李时珍路371号

· Contractor/有续签和转正机会

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:

● 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