Bob is responsible for managing the Quality Assurance and Regulatory Affairs at CML-US. He has a broad range of experience in developing, maintaining, and implementing GMP documentation and control from initial clinical materials through commercialization of Active Pharmaceutical Ingredients. Over his career, he has authored and successfully filed a dozen Drug Master Files, and has contributed to dozens of IND and NDA submission documents. He has also participated in numerous successful FDA and client audits of the Company’s facilities. Prior to joining CML, Bob worked for the startup company, Major Laboratories where he was a production chemist. As such Bob brings tremendous perspective to the Quality Unit as he understands the chemistry behind the documentation. He received a BS in Biochemistry from the University of Wisconsin, Milwaukee. |