Kiran Kavathe

About Kiran Kavathe

Over ten years of experience working in CMOs/CROs in Biotechnology/Bio-pharmaceuticals. Experienced with GLP, GMP, pre-clinical, clinical phase Materials Manufacturing and Process Validation Activities. Demonstrated ability to lead complex projects like platform process development for vaccines, aseptic fill and finish of clinical lots, mAB production (Fed batch, perfusion), Allogeneic as well as Autologous cell/gene therapy,Process Validation Prep & PPQ (process performance qualification runs) etc. Strong contributor in a team environment, detail-oriented, dependable, motivated and proven multi-tasker able to handle multiple projects well.Proficient using project management tools to oversee all elements of project life-cycle including client communication lead, scheduling/planning, meeting coordination, tracking of deliverables, reporting to stakeholders and risk mitigation. Experience with managing and overseeing subcontractors supporting commercial and government clients.Expertise in QA functions of material/process control, identifying non-conformance issues, executing CAPA, change controls, batch record review with disposition, equipment validation, inventory management, shipping dangerous goods, client customer service, internal and external auditing and project oversight within Quality Systems.

Experience

1. Senior Global Program Manager

   Amgen

   Oct 2023 — Present

Education

• University of Maryland - Robert H. Smith School of Business

  MBA

  2011 — 2014

• Montclair State University

  Bachelors, Biology

  2002 — 2006

• The Johns Hopkins University

  Masters, Biotechnology

  2007 — 2009

Skills

• Glp
• Biotechnology
• Gmp
• Lims
• Sop
• Validation
• Fda
• Lifesciences
• Capa
• Biopharmaceuticals
• Cell Culture
• V&V
• Laboratory
• Immunology
• Cell
• Life Sciences