Description
SUMMARY: * 30 years in the Pharmaceutical Industry including Quality Control, development, tech transfer, validation and project management * Pre-clinical and Phase I to Phase III Analytical Method Development, Qualification/ Validation * Excellent writing and communication skills (wrote SOP's, protocols and reports for method development, tech transfer as well validation programs). * Method development for proteins and small molecules (HPLC related methodologies) * cGMP practices dealing with QA and RA * Excellent problem solving skills
Work Experience
COMPANY | POSITION HELD | DATES WORKED |
---|---|---|
(Confidential) | Senior Chemist: Project Coordinator | 7/2012 - Present |
Pharmalucence Inc. | Analytical Development Supervisor Analytical Development Manager | 3/2008 - 9/2011 |
Method Development/Validation | Principal Research Associate, Analytical Development Laboratory | 1/2004 - 1/2007 |
Alkermes Inc. | Senior Scientist I, Analytical Development | 1/1990 - 3/2008 |
Bio Process Technologies, Inc. | Qa And Ra Pharmaceutical Technician | 1/1990 - 1/1999 |
Education
SCHOOL | MAJOR | YEAR | DEGREE |
---|---|---|---|
Massachusetts College of Pharmacy and Health Science | Drug Discovery and Drug Development | 2006 | Master Degree |