M*****5
发帖数: 3990 | 1 Bioanalytical Scientist – Biotech, New York City
The primary responsibility of the Bioanalytical Scientist is to develop and
qualify immunological-based quantitative assays for novel monoclonal
antibody therapeutics and pharmacodynamic markers in support of nonclinical
studies. To that end, the incumbent must be able to troubleshoot assays and
effectively compile and present scientific data to the members of the
department. In many cases these assays will be transferred to external
contract research organizations (CROs) for implementation in large scale GLP
studies. The incumbent will participate in the transfer of qualified
assays to CROs through the preparation of qualification reports and
experimental protocols. In addition to assay development and qualification,
the incumbent will be responsible for performing sample analysis and
preparing the associated bioanalytical reports. All aspects of sample
analysis, including non-linear regression analysis, sample tracking, and
report generation are managed through the WatsonTM laboratory information
management system (LIMS). The incumbent will serve as the administrator of
this system and thus will be responsible for all aspects of its function.
The incumbent will be responsible for coordinating laboratory support
activities including instrument and equipment maintenance and general
laboratory upkeep. The incumbent will provide supplemental support to the
department by performing searches of the scientific literature, assisting in
the analysis of pharmacokinetic and pharmacodynamic data, and preparing
documents associated with the submission of applications to various health
authorities.
Responsibilities:
1. Develop and qualify immunological-based assays, including enzyme
linked immunosorbent assays and electrochemilumunescent assays, in support
of nonclinical studies.
2. Perform sample analysis in support of nonclinical studies.
3. Prepare development/qualification reports and experimental
protocols.
4. Maintain all necessary laboratory documentation related to the
development and qualification of analytical methods.
5. Compile scientific data and present experimental results during
regular departmental meetings.
6. Troubleshoot immunological-based assays.
7. Manage the laboratory information management system (LIMS; WatsonTM
).
Required:
1. At least 3-5 years hands-on experience in a bioanalytical
laboratory conducting bioanalytical assay development, validation and sample
analysis, ideally in an industrial setting. Strong skills in the analysis
and interpretation of bioanalytical data, troubleshooting immunological-
based assays for detection of large molecules, and preparing method
development/qualification protocols and reports are essential.
2. Demonstrated ability to work independently, maintain a
strong attention to detail in a fast-paced dynamic environment while having
an appreciation for department and corporate timelines and meticulously
document all work is required.
3. Extensive experience using of Microsoft Office products,
specifically Excel, Powerpoint, and Word, and experience using laboratory
information management systems such as WatsonTM LIMS is required.
Steve
Steven Karski
Alchemy Scientific, Inc.
51 JFK Parkway
First Floor West
Short Hills, NJ 07078
(786) 347-6300
s*****[email protected] |
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