Genezen Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has appointed Natasha Rivas as vice president of Quality Assurance and Regulatory Affairs.
 
Rivas will be responsible for the design, implementation and iteration of the quality systems and processes that meet customers’ evolving needs and ensure delivery of safe and effective drug products.
 
Rivas brings more than 20 years of experience in the pharmaceutical and medical device industry, previously holding roles in quality control, assurance and regulatory affairs at Abbott, Hospira, Vetter Pharma and SCA Pharmaceuticals. She has an exemplary track record in building teams and quality systems to support drug development and clinical and commercial operations in the pharmaceutical industry.
 
Commenting on her appointment, Rivas said, “I’m excited to join Genezen at a pivotal moment in the company’s growth as the company develops new infrastructure and adds expertise on the way to becoming a leading lentiviral and retroviral vector CDMO.”
 
Genezen also recently appointed Ray Kaczmarek as CEO and Brok Weichbrodt as Vice President of Operations following news that the company has broken ground on a new multiphase master plan for a 75,000+ square foot cGMP-compliant Lentiviral vector production facility.
  
Rivas is a Certified Quality Auditor through ASQ and an active member of the Parenteral Drug Association (PDA).
 
Commenting on the appointment, Ray Kaczmarek added, “We are thrilled to add Natasha to our team at Genezen. Her credentials in developing and optimizing robust quality systems will be integral in our mission to make high-quality vector production accessible for innovative drug developers.”