Dave Boscher
Regulatory Coordinator at Merck
- Role
- Senior Specialist Regulatory Affairs Cmc Vaccines at Merck
- Location
- Phoenixville, PA, US
- LinkedIn followers
- 500 followers
About Dave Boscher
Experienced biopharmaceutical professional. Strong background in immunoassay design…
Experience
Senior Specialist Regulatory Affairs Cmc Vaccines
Jan 2012 — Present · West Point, PA, US
Responsible for coordination, preparation and submission of Chemistry and Manufacturing Control (CMC) sections for INDs, new vaccine products, and post-approval license supplements to existing biological product license applications (BLAs) or marketing authorization applications (MAAs) for US, international markets in eCTD format.Provide regulatory guidance to cross-functional teams regarding filing manufacturing changes
Education
Pennylvania State University
BS, Science
1979 — 1984
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Validation
- Gmp
- Experimental Design
- Glp
- Change Control
- Biopharmaceuticals
- Biotechnology
- Technical Support
- Regulatory Submissions
- Technology Transfer
- Staff Development
- Life Sciences
- Contract Manufacturing
- Monoclonal Antibodies
- Assay Development
- Regulatory Affairs
- Lifesciences
- Purification
- Hplc
- Vaccines
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