Kauser Hussain

About Kauser Hussain

I am a Director of Quality Control with over 15 years of experience in microbiology. I…

Experience

1. Director, Qc Microbiology

   Cartesian Therapeutics

   Jun 2024 — Present · Frederick, MD, US

   Established processes and procedures for Phase Cell therapy trials and commercial licensing for this startup, increasing efficiency of operations including personnel, material and product flow in the manufacturing suites, QC testing, and ensuring the on-time release of patient material.• Overseeing the validation of release test methods such as rapid Sterility, Mycoplasma and Endotoxin and the establishment of the QC Microbiology lab • Performed vendor audit to ensure compliance and maintain the right to operate • Budgeting, project management and set up of environmental monitoring (EM) program, including completing the baseline study, Environmental Monitoring Process Qualification (EMPQ), gowning program, and cleaning program • Established new programs, including coordinating, overseeing EM/cleaning and Microbiology testing at the sister site that manufactures Phase I and II Cell Therapy products• Collaborate with internal departments such as Quality Assurance, Manufacturing, Facilities, Manufacturing Science and Technology, and Validations• Investigation of non-conformances and adverse events• Guiding external vendors and consultants to ensure compliance and on-time roll out of programs• Hiring top talent and building the QC team

Education

• UW Foster School of Business

  Executive MBA Candidate, 2021-2023

• Center for DNA Fingerprinting & Diagnostics (CSIR)

  Senior Research Fellow, Molecular Biology

  2001 — 2004

• Osmania University

  Masters of Science, Genetics

  1999 — 2001

• Osmania University

  Bachelors of Science, Microbiology, Genetics, Chemistry

  1996 — 1999

• UW Foster School of Business

  Executive MBA Candidate

  2021 — 2023

• Auburn University

  Ph.D., Microbiology

  2004 — 2009