Dan Miskimin
Director of MSAT at Brainchild Bio
- Role
- Director of Msat at BrainChild Bio
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Dan Miskimin
Extensive experience and proven leadership in technology transfer, Process Development, Team Management, Process Engineering, Process Validation / PPQ, equipment design, cGMP production facility design, facility startup and commercialization of biologics. Depth of experience includes writing CMC sections of multiple files, strategic planning, team leadership, Contract Manufacturing Organization (CMO) support, process investigations and CAPAs. Skilled at creating and leading high performing teams across the commercialization lifecycle. Led dozens of successful clinical and commercial tech transfers and helped bring several products to market, including blockbuster drugs Enbrel and Prolia/Xgeva. Led and Mentored a team of Process Engineers that performed tech transfers under my guidance as leader of a MSAT group (Manufacturing Sciences and Technology).Participated in regulatory filings and inspections resulting in approvals for several biologics at several sites. Experienced in leading global cross functional teams and adhering to timeslines. PROVEN AREAS OF EXPERTISE• Technology Transfer & New Product Introduction• Process Troubleshooting, cGMP Investigation, Remediation and CAPAs• Contract Manufacturing tech transfers and support• Upstream and Downstream unit operations• Writing and reviewing IND & MA Submissions, and participation in PAI & Biennial Inspections • mABs, Fusion Proteins, ADCs • Stainless steel and disposable Process Platform development• Validation / PPQ• Facility Design, Start-up, Licensure• Budget Development and Adherence• Cross site process harmonization and Process Improvements• Team Leadership – proven line manager with focus on staff career development and engagement• Leadership and interaction with several cross functional teams over the life cycle of products, including Process Development, Process Characterization, Regulatory, QA, and Manufacturing
Experience
Director of Msat
Jun 2024 — Present · Seattle, WA, US
Education
Florida State University
Bachelor’s Degree, Chemical Engineering
1994 — 1996
Florida Atlantic University
Bachelor’s Degree, Psychology
1989 — 1992
Skills
- Gmp
- U.s. Title 21 Cfr Part 11 Regulation
- Pharmaceutical Industry
- Sop
- Fda
- Change Control
- Strategic Planning
- Validation
- Biopharmaceuticals
- Staff Development
- Life Sciences
- Biotechnology
- Technology Transfer
- Capa
- V
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