Akm Khairuzzaman
Senior Reviewer at FDA, Office of Pharmaceutical Quality, CDER, FDA
- Role
- Senior Reviewer at FDA
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Akm Khairuzzaman
Dr. Khairuzzaman is a recognized pharmaceutical scientist with 25 years of experience from the pharmaceutical industry in the US and the Food and Drug Administration (FDA). Currently, Dr. Khairuzzaman is serving as a Senior Reviewer in the Office of New Drug Products, OPQ. Dr. Khairuzzaman also served as an Acting Branch Chief at FDA\'s Office of Process & Facilities, OPQ, CDER, where he led a group of review scientists responsible for the assessment of chemistry, manufacturing, and controls (CMC) of new drug applications (NDAs), investigational new drug applications (INDs), and abbreviated new drug applications (ANDAs) seeking approval in the US market.Dr. Khairuzzaman joined the FDA in 2008 with seven (7) years of preformulation and formulation research experience from pharmaceutical industry. He has published one book chapter on 3D printing, several scientific papers in internationally renowned peer-reviewed journals, received several awards from FDA, engaged in numerous speaking activities organized by institutions notably the NIH, USP, ISPE, IFPAC, SBIA, AAPS, and CRS, and served on committees for several successful Ph.D. candidates from the Arnold and Marie Schwartz College of Pharmacy, Long Island University, NY.Dr. Khairuzzaman earned a bachelor\'s degree in Pharmacy. His graduate degrees, M.S. in Industrial Pharmacy and Ph.D. in Pharmaceutics, are from the Arnold and Marie Schwartz College of Pharmacy, Long Island University, New York, USA.
Experience
Senior Reviewer
Apr 2018 — Present
Education
Long Island University
M.S. & Ph.D
Skills
- Clinical Development
- Chemistry
- Drug Delivery
- V&V
- Lims
- Process Simulation
- Pharmaceutics
- Drug Discovery
- Biotechnology
- Chromatography
- Clinical Trials
- Elisa
- Formulation
- Pharmaceutical Industry
- Sop
- Fda
- Vaccines
- Analytical Chemistry
- Technology Transfer
- Protein Chemistry
- Cmc
- Nda
- Gmp
- Regulatory Affairs
- Lifesciences
- Purification
- Pharmacokinetics
- Pharmacology
- Cell Culture
- Lc-Ms
- Glp
- Dissolution
- Pharmaceutical Research
- Validation
- Biochemistry
- Hplc
- Regulatory Submissions
- In Vivo
- Toxicology
- Quality by Design
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