理化分析生物药气相色谱仪液相色谱仪 Responsibilities:
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The candidate will be the
Subject Matter Expert of separation and characterization assays within R&D
Analytical Development in Shanghai and be responsible for the gap assessment,
qualification, and transfer of separation and characterization assays to
support Clinical Trial Application (CTA), Biologics License Application (BLA),
and variation filings and product launches in China. The candidate will support
routine in-country testing for commercial batch released in China Health
Authority (HA) labs.
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The candidate will also
be responsible for trouble shooting of separation assays during in-country
testing throughout the product life cycle in China and Asia Pacific.
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The candidate will
conduct monoclonal antibodies testing using HPLC and CE-based technologies
and develop/optimize/qualify new analytical methods. The specific activities
may include but not limited to authoring/reviewing technical documents
(protocols, reports, SOPs, memos), hands-on execution of studies, reviewing notebooks,
Ordering and maintaining reagents, consumables and instrument needed for the
experiments, and guiding junior scientists.
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The individual will be
required to stay compliant with company policies and related regulations such
as GXP.
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The candidate will assist
with AD functional commercial biological products in-country testing activities
and project management system as needed.
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The candidate will report
to Senior principal scientist of China
Analytical Development. This position will be located in Zhangjiang,
Shanghai, China.

Qualifications
Ÿ Bachelor
or Master in biochemical engineering, biochemistry, pharmaceutical analysis,
analytical chemistry or related disciplines, with 1-3 years’ hands-on
experience in biotherapeutics analysis. Educational background may be extended
for candidates with exceptional experience and capabilities.
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Ability to work
collaboratively in global teams.
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In-depth large molecule
analytical knowledge with hands-on experience on the characterization and
separation methods such as HPLC, and capillary electrophoresis techniques.
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Strong analytical problem
solving, critical thinking and attention to details.
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Excellent oral and
written communication skills in both English and Chinese.
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Organized and
detail-oriented.
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Self-motivated for personal
development.