Description
Qualifications Summary Laboratory Manager with extensive experience in regulated pharmaceutical manufacturing and research and development with more than 10 years of management experience. Thorough understanding of regulated Laboratory environments including but not limited to GMP, GLP, GDP and 21 CFR Part 11. Quick learner with proven track record of driving success. Skilled at navigating FDA and vendor audits. Implemented continual growth of QC Chemistry laboratory while managing an annual budget exceeding $1,000,000 a year. Streamlined key processes and procedures resulting in a 3-fold increase in productivity. Proven record of driving low laboratory cycle times. Experience managing both internal and external contract laboratories. Known for the ability to strategically plan projects, forecast and maintain budget restrictions, and complete projects under tight timelines. Manager adept at developing new employees to high levels of productivity while guiding professional development. Expert in implementation, validation, and use of Watson LIMS. Project team leader for multiple computer validations including but not limited to Watson LIMS, LCQuan, and validation of automation equipment. Skilled at sample analysis and sample extraction techniques, HPLC, LC/MS, set up, programming, software validation, and use of automation equipment. * Project Management, PMP * QC Laboratory Management * Stability Testing * Finished Product Release Testing * FDA Audit Experience * Strategic Planning * Bio-Analytical Operations * Watson LIMS * Regulatory Compliance * Laboratory Automation * Validation Documents * LCMS/HPLC Method Development * Software Validation * Time Management
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| (Confidential) | Laboratory Manager | 1/2013 - Present |
| Actavis Pharmaceuticals | Finished Product Supervisor | 1/2010 - 10/2013 |
| Gilead Sciences Inc. | Associate Scientist | 1/2003 - 7/2010 |
| Triangle Pharmaceuticals | Development Scientist Associate Scientist / Intern | 1/1999 - 1/2003 |
Accomplishments
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