Madushini Dharmasena

Senior Pharmaceutical Quality Assessor @ FDA | Microbiology Ph.D.

Role: Senior Pharmaceutical Quality Assessor at FDA
Location: Fulton, MD, US
LinkedIn followers: 500 followers

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About Madushini Dharmasena

Microbiology reviewer

Experience

Senior Pharmaceutical Quality Assessor
FDA
Mar 2021 — Present · US
Secondary review of BLA and BLA supplements. Managed day to day review work of more than 16 microbiology and facility reviewers and providing robust training.‒ Leading more than 35 inspections and providing robust training to new inspectors. ‒ Meet with industry representatives to exchange information and provide guidance and planning scientific and regulatory conferences.

Education

Geisel School of Medicine at Dartmouth
Ph.D, Microbiology and Immunology
2001 — 2008
University of Colombo
B.Sc. (Hons), Biochemistry and Molecular Biology
1996 — 2000

Skills

Cell Culture
Purification
Biochemistry
Western Blotting
Pcr
Infectious Diseases
Vaccines
Molecular Biology
Immunology
Microbiology
Phage Display
Genetics
Enzyme Kinetics

Contact information

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•••••@fda.gov
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Current company

FDA

Government Administration · 18K employees · Silver Spring, Maryland, United States

The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

fda.gov

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About Madushini Dharmasena

Experience

Senior Pharmaceutical Quality Assessor

Education

Geisel School of Medicine at Dartmouth

University of Colombo

Skills

Find verified contacts for anyone on LinkedIn