Drew M. Love, Paine College c/o1989, is a Compliance Officer with the US Food and Drug Administration in Silver Spring, MD where he reviews draft guidance, submissions and inspectional findings to ensure regulatory compliance. This 1989 Paine College graduate also is a member of Mu Lambda Chapter of Alpha Phi Alpha Fraternity in Washington, DC.
Prior to joining the federal government, I worked in private industry as a Quality Assurance (QA) professional and consultant. I have worked as a QA Microbiologist with 15 years of experience conducting audits, investigations, quality metrics data analysis and consent decree remediation. As an ASQ Certified Quality Manager, Certified Quality Auditor and Certified Quality Engineer, I have worked across disciplines to alert client/managers to inspectional variance to ensure an informed, appropriate and timely response.
I continue to hone my scientific training and communication skills to perform statistical process control forecasts of critical to drug product quality attributes and provide informed instruction to immediate stakeholders.
The primer steps to success were taken at Paine College, which afforded me a superior liberal arts education. My studies in this nurturing environment prepared me for studies at Harvard and Brown Universities. I am thankful to Paine's dedicated staff who encouraged and coached with confidence.
Now is an exciting time for growth at FDA and I plan to develop myself so I can help strengthen the Agency by communicating and championing its goals. Promoting and protecting the public health inspires me.
2015 CDER Office of Compliance Commendation for Exceptional work related to Wallcur Simulate Saline Incident
Which Dimension does the cell divide evenly dueing Cytokenesis? Drew M. Love, Eddie G. Moore, Department of Biology, Alabama State University Montgomery, AL 36101 and Joel A. Swanson, Department of Anatomy and Cellular Biology, Harvard Medical School, Boston, MA 02115. The Journal of the Alabama Academy of Science, Volume 66 No 1-2, April 1995. p. 17.
The Savannah River Plant Airborne Radionuclide Dispersion Model, W.F. Lawless, D. M. Love, D.S. Phillips, and L. Cecil Department of Mathematics, Paine College, Augusta, GA Georgia Journal of Science Vol. 47 No. 1 1989 p. 28.
Most Memorable Moment:
Pledging Eta Alpha Chapter of Alpha Phi Alpha Spring 1987 "Sangfroid"; Homecoming 1989;
Consumer Safety Officer|
U.S. Food and Drug Administration
From January 2014 to Current • 12 year(s)
Review compliance findings for biopharmaceutical firms and advise CDER Office of Compliance management on enforcement recommendations including injunctions, warning letters, and consent decrees.
QA Supervisor - QA Operations|
Dendreon Corporation
From December 2010 to Current • 16 year(s)
Lead team of three direct reports in cross-functional teams to ensure efficient root cause analysis of customer complaints, batch records preparation, CAPA, and compliance investigations.
Quality Compliance Specialist|
CIBA VISION via AEROTEK SCIENTIFIC, LLC
From May 2010 to December 2010 • 0 year(s)
Provided QA technical support in review and approval of draft investigations, analytical test requests, and international raw materials test data.
Quality Assurance Manager|
Revogenex, Inc
From May 2009 to April 2010 • 1 year(s)
CMO supply chain management, project management and quality management for clinical trial management with CROs in India and CMOs in Poland.
Quality Assurance Manager|
Biogen IDEC
From September 2007 to October 2008 • 1 year(s)
Product Quality Manager responsible for ensuring contractors prepared and investigated nonconformance related to handling, storage, manufacturing, and distribution of finished product.
Contract Manufacturing QA|
Amgen Inc
From April 2005 to July 2007 • 2 year(s)
Provided timely advice and support of CMO facilities in Germany and North Carolina for Enbrel and Epogen products.
Quality Engineer|
Abbott Labs
From August 2003 to April 2005 • 2 year(s)
Ensured full QA/QC compliance for pharmaceutical manufacturing facility and led investigations to identify root causes and develop resolution strategies.
Quality Compliance Lead Investigator IV|
Wyeth Vaccines
From August 2002 to August 2003 • 1 year(s)
Responsible for investigating, completing, tracking, and trending manufacturing discrepancies and resulting commitments within Bulk Vaccine Manufacturing facilities.
Quality Compliance Specialist|
Cardinal Health, NA
From August 1999 to July 2002 • 3 year(s)
Certified that methods, facility and controls for manufacture of drug products conform with current Good Manufacturing Practices and prepared Annual Product Reviews.
Consultant|
Cardinal Health
From May 1999 to July 1999 • 0 year(s)
Analyzed cosmetic, pharmaceutical and nutritional active pharmaceuticals and excipients to ensure compliance with approved inspection protocols and lab methods.
