Umar Maharoof
Senior Director, Head of CMC - Pharmaceutical Development, cGMP, NDA / IND / CTA
- Role
- Sr Director, Head of Cmc at Neuraly Inc
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Umar Maharoof
Pharmaceutical professional with expertise in drug development and CMC strategy, including Plecanatide phase 3 development and NDA authoring for marketing approval. Experienced in governance, portfolio committees and cross-functional team collaboration on high-tier projects. Skilled in drug substance and drug product process development, GLP and cGMP manufacturing, CDMO management, technology transfer and regulatory documentation. Proficient in advancing drug delivery technologies and developing lifecycle management strategies for innovative dosage forms.
Experience
Sr Director, Head of Cmc
Nov 2023 — Present · Gaithersburg, MD, US
Head of CMC, Phase 2, 3 Development.
Education
University of Peradeniya
Bachelor of Science (B.S.), Chemistry
Wayne State University
Ph. D., Organic Chemistry
Bowling Green State University
Master of Science (M.S.), Organic Chemistry
QA/RA Course, Pharmacy School, Temple University
Global CMC IND Submissions
Skills
- Lead Change
- CRO
- Drug Design
- Biotechnology
- Drug Development
- Nmr
- Validation
- Mass Spectrometry
- Medicinal Chemistry
- Organic Chemistry
- Life Sciences
- Pharmaceutical Industry
- Hplc
- Regulatory Submissions
- Oncology
- Chemistry
- Chromatography
- Drug Discovery
- Organic Synthesis
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