William Zedalis
University of Massachusetts Lowell
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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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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.
...See MoreWork Experience
qc cmc senior manager
Senior Scientist | Quality Control Manager | CMC | External
Biotechnology Research
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.
Education
Chemistry
Skill
Chemistry
Analytical Chemistry
Organic Synthesis
Chromatography
Purification
Drug Delivery
Uv
Assay Development
Lc Ms
Hplc
Drug Discovery
Medicinal Chemistry
Organic Chemistry
Nmr
V&v
Technology Transfer
Ind
Clinical Development
Characterization
Certification
Colleagues
James Bilotta
Senior Vice President | Chief Information Officer
Jeff Poulton
cfo at alnylam pharmaceuticals
Yvonne Greenstreet
Chief Operating Officer
Dr. Yvonne Greenstreet
Chief Executive Officer
Timothy Maines
chief technical operations & quality officer at alnylam pharmaceuticals
Other Named William Zedalis
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William Zedalis works for Alnylam Pharmaceuticals
William Zedalis's role in Alnylam Pharmaceuticals is qc cmc senior manager
William Zedalis works in the industry of Biotechnology Research
William Zedalis's colleagues are James Bilotta,Jeff Poulton,Yvonne Greenstreet
William Zedalis's latest job experience is qc cmc senior manager at Alnylam Pharmaceuticals
William Zedalis's latest education in University of Massachusetts Lowell