Cara Sholter joined Immunomic Therapeutics, Inc. in April 2021. She has over 20 years of progressive expertise across all GxP areas in the highly regulated biopharmaceutical industry. Cara is proficient with developing and deploying Quality Systems that create a strong quality culture, which includes continuous improvement and alignment with applicable regulations and GxP guidelines. She has process and product experience with biopharma and medical devices, upstream and downstream, filling and inspection, packaging operations, aseptic manufacturing for both liquid and lyophilized dosages. Cara is skilled in FDA interactions, corrective and preventive actions, risk assessments, complaint investigations, documentation management, and quality vendor management.
Prior to joining ITI, Ms. Sholter worked for Lonza as the Head of LAL (limulus amebocyte lysate) Quality Assurance. She has assumed increasing roles of responsibility within Quality Assurance positions at various BioPharm and Medical Device companies, including Sanofi Pasteur and AstraZeneca Biologics.
Ms. Sholter earned a Bachelor of Science degree in Chemistry from Kent State University.
Sign up to view 0 direct reports
Get started
This person is not in any teams