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Regeneron Pharmaceuticals, Inc.
Associate Director - Sample Analysis & Sample Management
Location: Tarrytown,
New York
10591
Posted on:
6/17/2009 9:24:49 AM
Postion type:
Full time
Job Code:
1546
Required Education:
PharmD
Salary:
DESCRIPTION
Located in historic Tarrytown, New York, convenient to New York City, Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and pain, and has preclinical programs in other diseases and disorders.
With a strong research base and product focus, Regeneron is able to understand the biology of specific disease states, discover potential therapeutic candidates, and evaluate product candidates in clinical trials. Regeneron has developed several proprietary platform technologies and incorporated these into a comprehensive system to accelerate the discovery and design of fully human antibodies and move these candidates rapidly into clinical development.
An Associate Director in the Sample Analysis and Sample Management group will direct a group of scientists and technicians responsible for performing immunoassays under GLPs on clinical samples in order to determine the levels of drug, drug complexes, anti-drug antibodies and drug target. They will be responsible for guiding clinical sample analysis efforts for each drug program, ensuring quality analysis of samples, establishing deliverables, communicating program objectives and presenting QCd analysis results to project teams and senior management. They will be responsible for the GLP compliant management of all samples from both clinical and preclinical studies, including the coordination of sample shipments from clinical sites and CROs and the resolution of any sample discrepencies. They will also be responsible for writing sample analysis reports, SOPs and sections for both IND and BLA submissions.
Essential Functions of the job:
*Ensure quality analysis of samples under GLPs for the measurement of drug, drug complexes and anti-drug antibodies
*Direct a team of scientist performing immunoassays using both manual and automated systems
*Direct a team of technicians managing samples under GLPs from clinical and preclinical studies
*Assume leadership role to drive projects forward
*Actively participate as a member of multiple joint project teams to help direct drug development programs
*Effectively communicate company goals to subordinates and provide clear updates to senior management
*Write sample analysis reports SOPs and sections for BLA and IND submissions
*Coordinate activities between groups within Regeneron and our external partners
*Ensure complete and accurate documentation is maintained
*Ensure GLP, safety and ethical compliance is maintained
*Ensure that all employees are up to date on all GLP training
*Serve as role model and encourage teamwork within and between groups; promote exchange of ideas
*Ensure lab safety rules are followed, as per company policy
*Provide timely and accurate employee evaluations and set clearly defined goals for subordinates
REQUIREMENTS:
*PharmD is required
*Extensive knowledge immunoassays and current technologies and formats for performing immunoassays.
*Excellent oral and written communication skills in order to effectively communicate.
*A clear understanding of GLP's and regulatory guidelines and significant experience in operating in a GLP environment.
*Experience working with LIMS (preferably Nautilus) and SoftMax.
*At least 6 years experience supervising the analysis of samples using immunoassays under GLPs
We offer an extremely competitive compensation and benefits package to all our employees, including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
EOE/M/F/D/V
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