Jason Plasch
Biopharma Sr. Capital Project Manager
- Role
- Engineering Project Leader at Baxalta
- Location
- Thousand Oaks, CA, US
- LinkedIn followers
- 500 followers
About Jason Plasch
More than 18 years experience in the cGMP manufacturing of human Biopharmaceuticals and production/personnel management.Subject Matter Expert of the Cell Culture manufacturing process and associated scale up, bioreactor production and Media/Buffer production.Experienced with regulatory inspections from the FDA, EU and other geographies. Leader in change control, project management and issue investigation/resolution.
Experience
Engineering Project Leader
Mar 2015 — Present · Thousand Oaks, CA, US
Program managment for engineering projects related to product throughput improvement•Develop and prepare written project plans for tasks, responsibilities, scope, budget, resources and schedule•Provide all project communications regarding project progress to team, sponsor, and stakeholders•Oversee project team, milestones and project performance against scope, plan and budget•Investigate/Troubleshoot problems associated with process or equipment
Education
Ventura High School
High School
1990
Westmont College
Bachelor’s Degree
2004 — 2006
Ventura College
Associate’s Degree, Engineering
1994
Skills
- Cell Culture
- Cross-Functional Team Leadership
- Change Control
- Capa
- Gmp
- 21 Cfr Part 11
- Biotechnology
- Project Management
- Validation
- Pharmaceutical Industry
- Sop
- Fda
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