Kevin John Jose
Madison,WI
Summary
Experienced Upstream Professional with 10+ years developing, transferring and characterizing biologics for cGMP manufacturing. Effective leader with 5+ years of coaching/mentoring individual contributors to cross-functional team members.
Overview
11
11
years of professional experience
Work History
Manager, Upstream Process Development
Catalent Pharma Solutions
04.2017 - Current
- Manage Process Development Team with development and transfer of Biologics for cGMP manufacturing (reduced transfer time by 50% with development of robust platform processes)
- QbD based approach identification and optimization of critical attributes for biologics that include Monoclonal Antibodies (MAb’s), Fusion Proteins, Recombinants, Antibody Drug Conjugates (ADC’s)
- Authoring/reviewing technical documents for cGMP readiness. Improved technical document templates to reduce timelines.
- Active member of deviation management systems and implementing change through a continuous improvement philosophy
Scientist, Upstream Process Development
Oncobiologics Inc.
02.2014 - 03.2017
- Process development of Biosimilars (adalimumab, bevacizumab, trastuzumab) in small scale bioreactors and subsequent scale up of the process to Clinical Manufacturing Unit
- Design of process parameters and process instructions for the development of MAb’s in the company pipeline
- Cell culture development with different basal, feed and supplements to conform the developed MAb to acceptable Quality Attributes
- Ambr studies to determine top clones for early stage MAb’s for a specific product through process design and titer evaluation
- Transfer of material to Downstream Development by harvesting product from bioreactors through Depth Filtration
- Technology Transfer Protocol generation for Clinical Manufacturing of a developed process for Biosimilar Production in the clinical facility
- Bioreactor set-up, cleaning, sterilization and assembly
- Maintaining Electronic Notebook for documentation
Education
Master of Science - Biotechnology
The Pennsylvania State University
State College, PA12.2013
Skills
- SME in Upstream Process Development
- Biologics development and manufacturing
- Scale Up/Scale Down
- Process Improvements/Process Characterization
- Perfusion/PAT/Continuous processing
Timeline
Manager, Upstream Process Development
Catalent Pharma Solutions
04.2017 - Current
Scientist, Upstream Process Development
Oncobiologics Inc.
02.2014 - 03.2017
Master of Science - Biotechnology
The Pennsylvania State University
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