Ian Sobotka
Experienced CSV Professional
- Role
- Associate Director, IT Csv at Corcept Therapeutics
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Ian Sobotka
Ian graduated with a B.S. in Neuroscience from Dickinson College in Carlisle, PA in May 2010. Following this, Ian spent two years as a Neuroimaging Coordinator assisting in medical academic research, focusing on microhemorrhages in the brain following both ischemic and hemorrhagic strokes. During this time, Ian developed proficiency in scientific writing, data gathering and analysis, and database management. In May 2012, Ian accepted a position working as a Cellular Therapy Specialist for Progenitor Cell Therapy (PCT), where he worked in GMP manufacturing and validation. In addition to his GMP manufacturing duties, Ian also gained expertise in material management, process, computer system, equipment and clean room validation, and spearheaded a transition from a paper material management system to a digital one. Following two years of service at PCT, Ian joined Commissioning Agents, Inc. as a Validation Scientist. Ian served in commissioning and validation protocol generation and execution roles, specializing in pharmaceutical companies. After seven months of cleaning validation and building commercialization projects, Ian accepted a role in Hayward, CA, working as a validation engineer for YPEX Technology Resources, on assignment at Impax Laboratories. His duties include designing, authoring, executing, and reporting on facility, utility, and equipment modification qualifications, writing position statement reports elaborating current stances based on FDA guidance, authoring SOPs, and performing continuous facility and utility improvement through requalifications and system review.When not working, Ian enjoys hiking, backpacking, climbing, trail running, playing rugby, and any outdoor activity.
Experience
Associate Director, IT Csv
Oct 2025 — Present
Education
Dickinson College
Bachelor of Science (BS), Neuroscience
2006 — 2010
Skills
- Validation
- Gmp
- Biotechnology
- Aseptic Technique
- Sop
- Aseptic Processing
- Cell Culture
- Laboratory
- Fda
- Pharmaceutical Industry
- Life Sciences
- Laboratory Skills
- Computer System Validation
- Process Improvement
- Cleaning Validation
- Facility Qualification
- Laboratory Equipment
- Report Writing
- Logistics
- Materials Management
- Protocol Development
- Neuroimaging
- Proposal Writing
- Microsoft Office
- Glp
- Hvac
- Good Laboratory Practice (Glp)
- Standard Operating Procedure (Sop)
- U.s. Food and Drug Administration (Fda)
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