Michael Ritter
Experienced Operations and Business Development/Sales Director at Minaris Advanced Therapies
- Role
- Director Msat Validation at Minaris
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Michael Ritter
Specialties: Process Development and Tech Transfer, Micro-scale to Large-scale.Large Scale Production of Biological Materials, Viral Vectors, Cell and Gene Therapies Seed preparation and development. Pilot plant operations and equipment validation/qualification. Native antigen production and recombinant expression. Industrial Aseptic Processing and Filling.Final Product fill and inspection. FDA/CBER/CDER and EU process development and qualification. Media development and qualification studies.Guest lecturer for Applied Microbiology, Industrial Microbiology, and other courses at East Stroudsburg University, Blinn College, Texas A&M, and University of Houston.
Experience
Director Msat Validation
Jun 2024 — Present · Durham, NC, US
In addition to my duties previously in MSAT I have added a full site wide Validation team responsible for 4x facilities, 42 GMP MFG suites for Cell and Gene Therapies, and sqft of Testing and Analytical Development. My validation team supports both Facilities CQV and full equipment Validation from IQOQ to PQ in support of licensure. My Validation team supports both MFG and Testing, as well as full automation and CSV requirements. My team maintains a mix of fulltime, part-time, and contract resources to support site Validation activities.I continue to be the single point of contact for all Technical Sales at AT for both Cell and Gene Therapies from clinical through commercial operations. As well, I continue to support and coauthor SOWs, Proposals, Change Orders, and other sales documents as well as support Business Development through site visits, customer interactions, and as well as acting as a Sales Associate bridging gaps in coverage in all markets.
Education
University of Miami
Environmental Eng.
1994 — 1997
Commonwealth University-Lock Haven
BS, Cell Bio, Ecology Minor Chem
1998 — 2002
East Stroudsburg University of Pennsylvania
MS, Biology
2006 — 2009
Skills
- Cell Culture
- Purification
- Sop
- Industrial Microbiology
- Fda
- Gmp
- Biopharmaceuticals
- Glp
- Biotechnology
- Microbiology
- Validation
- Quality Assurance
- Manufacturing Operations Management
- Gxp
- Aseptic Processing
- Chemistry
- Standard Operating Procedure (Sop)
- U.s. Food and Drug Administration (Fda)
- Lims
- Change Control
- Technology Transfer
- Fermentation
- Vaccines
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