1035 O'Brien Drive
Industry: Clinical & Scientific
Job Number: 16303
Senior Scientist, Assay D?
Menlo Park, CA<%? 2Fb>
Assay Development team is looking to bring onboard a Senior?
Scientist. This individual will support the Assay Development?
team by developing, qualifying, transferring, and troubleshoot?
ing quantitative, semi-quantitative, and qualitative assays in?
support of research, nonclinical, clinical, and CMC progr?
Core Duties and Responsibilities?
- Plan strategies?
for and participate in the development, qualification, and t?
ransfer of quantitative and semi-quantitative bioanalytical method?
s to support product release
- May also con?
tribute to development, qualification, and transfer of bioanal?
ytical methods to support preclinical and clinical assaysPresent results, conclusions, and implications?
to project teams and senior management.
articipate in the transfer of processes, technology, and ass?
ays to/from internal and external collaborators and outside ve?
- Maintain a detailed awareness of indu?
stry guidance and standards for assay validation and performance?
- Maintain current knowledge of advancing te?
chnologies and propose their applications to ongoing projects.%3?
- Author standard test methods and best-prac?
tices documents for the Assay Development group
%? 3Cli> Contribute to development reports
bute to CMC protocols and regulatory reports
Independently plan, implement, and complete significant proj?
ects with minimal supervision.
in scientific meetings and produce original peer-reviewed public?
nts and Experience:
nce with NGS a plus
Knowledge of MicroSof?
t Office Suite. Experience with SoftMax Pro a plus. Experi?
ence with GraphPad Prism a plus. Experience with JMP a plu?
- Experience working as part of a project teamUnderstanding of QC assay requirements%0?
- Understanding of assay validation
xperience in developing large-molecule and biologics assays in%2?
0a regulated environment to support some or all of the follo?
wing: potency assays, titer assays, cell-based assays, t?
ransduction assays, infectivity assays, qPCR assays, digital%2?
0drop PCR, ELISA, MSD, or other ligand-binding assay tec?
- Peer-reviewed publications in the%2?
0area of assay development a plus
0knowledge of basic statistics