Experience

University of Colorado Anschutz Medical Campus

• United States
• Higher Education
• 700 & Above Employee

• Cell Therapy Process Engineer II

  • Oct 2017 - Present

  -Facilitates transfer of a new product into the facility-Creates cGMP batch records for cell therapy processes-Drafts regulatory filings including pIND and IND submissions-Helped the facility build overall methods and practices in order to successfully complete the first clinical run to provide patient material for a cell therapy product. -Assists in performing basic cell therapy operations in the GMP suite-Completes documentation using Good Documentation Practices-Drafts and reviews SOPs-Identifies, raises, and completes investigations, root causes, and corrective and preventative actions for deviations.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist

  • Nov 2016 - Aug 2017

  • Large scale process development scientist responsible for optimizing monoclonal antibody production and product quality in CHO systems with and without ATF (Alternating Tangential Flow) technology. • Involved in technology transfer of the upstream ATF platform process to the Pilot Plant at the 2000L scale. Works closely with GMP operations to ensure timely and effective transfer. • Responsible for the supply of large-scale cell culture batches using 10L and 50L Wave, 50L and 200L stainless steel, and 50L and 200L Single Use Bioreactors (SUBs). • Upstream departmental project lead on a microbial asset interfacing with downstream purification, analytical, project management, regulatory, and pilot plant groups. Currently involved in preparing pre-IND and IND/IMPD regulatory filings. • Departmental representative for safety and emergency coordinator, conducts quarterly safety audits and ensures all spaces and personnel are consistently safety compliant.

• Associate Scientist

  • Jan 2014 - Oct 2016

  • Developed a platform fermentation process for E. coli Phase I assets using complex and chemically defined media using ambr250, 15L, and 150L stainless steel bioreactors. • Worked side by side in the Pilot Plant with GMP operations to troubleshoot tech transfer issues using root cause analysis tools to successfully complete toxicology and clinical trial material campaigns. • Cell culture process development of a platform ATF process in CHO systems.• Chemically defined media optimization of a Phase I CHO process to increase therapeutic protein production. • Performed generational stability studies through 150 generations and analyzed culture growth, production, and product quality to determine stability of the master cell bank. • Creates CHO, NS0, and E. coli development and working cell banks for the department. • Preparation, operation, and break down of 10L and 50L wave bags, ambr250, 3L glass bioreactors, 50L and 200L stainless steel bioreactors, 50L and 200L SUBs.



Thomas Jefferson University

• United States
• Higher Education
• 700 & Above Employee

• Research Technician

  • Feb 2013 - Dec 2013

  Studied the roles of various checkpoint mechanisms and their involvement in meiotic commitment in the budding yeast Saccharomyces cerevisiae using molecular biology techniques.

• Research Technician

  • Feb 2012 - Jan 2013

  Examined relationships between SUMO protein mutants and DNA damage repair pathways using molecular biology techniques. Prepared reagents, maintained up-keep of the laboratory, and ordered supplies as needed.



Ramapo College of New Jersey

• United States
• Higher Education
• 700 & Above Employee

• Research Technician - Student

  • Jan 2011 - Apr 2011

  Explored bacterial co-resistance between antibiotics and the anti-microbial agent Triclosan using microbiology techniques. Explored bacterial co-resistance between antibiotics and the anti-microbial agent Triclosan using microbiology techniques.