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· 公司：上海羅氏制藥有限公司　
· 職位：大分子生物分析科學(xué)家 LM Bioanalytical Scientist
· 地點(diǎn)：浦東新區(qū)李時(shí)珍路371號(hào)
· Contractor/有續(xù)簽和轉(zhuǎn)正機(jī)會(huì)
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