Director, Biolanatycal Sciences & GLP Compliance Job

Employer Name: BiotechCrossing	SpiderID: 2388275
Location: Cambridge, Massachusetts	Date Posted: 7/23/2008
Wage:	Category: Biotech
Job Code: 6731939

Job Description:
This individual will provide leadership within DMPK and also mentor and coach scientists for career development.Key Responsibilities: Supervise and Manage the Bioanalytical Sciences Group within DMPK.Supervise Scientists in LC/MS assay methods set-up and validation to support drug product development in compliance with Regulatory requirements.Manage resources to complete samples from GLP compliant toxicology studies, cGCP compliant clinical studies, and also PK Formulation studies to ensure high quality and timely generation of raw data.Ensure full GLP compliance within DMPK - i.e., GLP lab activities and prepare for regulatory audits of all data.Take corrective action within GLP with regards to SOPs. Ensure maintenance of 90% SOP compliance and training of scientists at all time.Review, QC raw data and approve data for timely transmittal to various study directors, and or other department stake holders. Complete BA and PK/TK reports in collaboration with the other groups and finalize the reports for archiving. Minimum Requirements Ph.D.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
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Contact Information:

Contact Name: -	Company Type: Employer
Company: BiotechCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com