GLP/GMP Project Manager
Location: Rochester New York
Description: University of Rochester is at the momment seeking for GLP/GMP Project Manager right now, this job will be placed in New York. Detailed specification about this job opportunity kindly read the description below. Opening
Full Time 40 hours Grade 054 Neurology/Ctr Trans Neuromed
Schedule
9AM-3PM
General Purpose
Provide oversight of the New York State Stem Cell resear! ch consortia contract, which University of Rochester is a sub awardee. This will include, but not be limited to, administrative oversight of the contract including, regulatory filings, and working with animal care and institutional review board committees.
Specific Responsibilities
With broad guidance as to research project objectives, primary responsibilities in administrative coordination of the NYSTEM Consortia research project conducted in the Cell & Gene Therapy division of the Center for Translational Neuromedicine (CTN). Secondary responsibilities include most or all of the following, as well as other related duties:
Oversee day to day project operations to ensure that laboratory work progresses according to goals and milestones. Monitors timeline and ensures that milestones between the respective labs, specifically the Goldman Lab and GMP facility, are being met. Assists in preparation and submission of all progress reports. Administrative coordinator wi! th internal labs working on the contract, as well as with coll! aborators, which include both Buffalo and Upstate, where the prime contract is held, as well as with NYS extramural grants administration. Includes biweekly conference calls and web conferences with collaborators and state administrators. Responsible for understanding FDA requirements for early phase cell therapy products and educating the faculty and staff working on this project, on what is required. Will be responsible for writing clear and concise Standard Operating Procedures (SOP) and maintaining standard operating procedures for FDA submission, as well as applicable UCAR and IRB protocols. Responsible for compliance with regulatory requirements and good clinical practices; adhere to all effective SOP and safety requirements Document all work consistent with Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP) requirements. Respond to institutional Quality Assurance oversight by providing appropriate documentation. Responsible for interacting and lead! ing efforts with regulatory experts on the compilation and filling of an IND with the FDA. Collaborate with the Institutional Research Regulatory Compliance officers and with the Quality Assurance Unit
Requirements
Master's degree in a biological science or MBA. With a Master's degree, a minimum 3 years of professional experience in the field of assignment. With the equivalent of a Master's degree in experience, training and education, 5 years in the field of assignment with some independent research experience; or an equivalent combination of experience, training and education.
Prior experience in a GMP or GLP environments is strongly preferred. Experience required to ensure compliance with regulatory and quality policies and procedures. Candidate should possess significant project management experience in a technical environment with the ability to utilize current project management tools.
How To Apply
All applicants must apply online.
Th! e University of Rochester is an Equal Opportunity Employer.
- . If you were eligible to this job, please email us your resume, with salary requirements and a resume to University of Rochester.
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This job starts available on: Sun, 14 Jul 2013 02:54:36 GMT