William Zedalis
qc cmc senior manager@ Alnylam Pharmaceuticals
Cambridge, Massachusetts, United States
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William Zedalis is a highly experienced QC/CMC Senior Manager with 24.7 years of work experience in regulatory filings, chemistry, manufacturing, and control (CMC) support. He specializes in broad analytical methods, assay development, methods transfer, and method validation. He is skilled in regulatory filing authoring, CMC/QC lead for commercialized products, infusion system/drug compatibility analysis, assay development, methods transfer, and stability protocol management. Throughout his career, he has worked at Alnylam Pharmaceuticals, Nitto Avecia, Johnson Matthey, and GE Healthcare. He is based in the United States.
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Emails and Phone Numbers

@alnylam.com
@gmail.com
+1 833256****
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About

QC/CMC Senior Manager with extensive/solid experience in regulatory filings, and Chemistry, Manufacturing, and Control (CMC) support. Special expertise in broad analytical methods, assay development, methods transfer, and method validation. Stability manager for custom raw materials as well as specification setting (lipids, novel linkers, solid support GalNAc, amidites). Manager for all E&L commercial programs at Alnylam (DP fill line components, container closure systems, and pre-filled syringes)Specialties: Regulatory filing authoring, CMC/QC lead for commercialized product (Oxluma). Infusion system/drug compatibility analyst, assay development, methods transfer, stability protocol management.

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Work Experience

675 W Kendall St, Cambridge, Massachusetts, 02142, US

Biotechnology Research

2209
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William Zedalis's Professional Milestones

  • Senior Scientist | Quality Control Manager | CMC | External (2005-04-01~): Implementing robust quality control measures to ensure adherence to CMC standards and external initiatives.
  • Synthetic Chemist (2001-05-01~2005-03-01): Developed innovative chemistry techniques to improve chemical industry standards and improve overall product quality.
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Education

University of Massachusetts Lowell
University of Massachusetts Lowell

Chemistry