Gowri Sukumar, MS, RAC (Global)

Gowri Sukumar, MS, RAC (Global), has a diverse range of work experience in the field of regulatory affairs and CMC (Chemistry, Manufacturing, and Controls).

From March 2021 to the present, Sukumar has served as the Senior Director of CMC and Regulatory Affairs at Iterion Therapeutics. In this role, they are responsible for developing the overall CMC strategy and overseeing all activities related to the process development and validation of active pharmaceutical ingredients and drug products. Additionally, they ensure the timely delivery of drug products for clinical trials.

Prior to joining Iterion Therapeutics, Sukumar worked as the Director of CMC and Regulatory Affairs at the same company from September 2018 to March 2021. In this position, they led the CMC activities, collaborated with product development and clinical teams, and played a crucial role in the development and validation of active pharmaceutical ingredients and drug products.

From July 2016 to September 2018, Sukumar worked as the Associate Director of CMC and Regulatory Affairs at ESSA Pharmaceuticals. Their responsibilities included providing CMC and regulatory leadership for a lipophilic oral dose small molecule indication for prostate cancer. Gowri also supported virtual manufacturing through interactions with contract manufacturing organizations (CMOs).

Sukumar's work experience also includes a part-time research staff position at Baylor College of Medicine from March 2016 to October 2016. In this role, they participated in all aspects of research, including the development of research plans and protocols, review of existing subject matter, and interface with regulatory authorities.

Prior to Baylor College of Medicine, Sukumar worked at Biocon from January 2014 to May 2015 as a Senior Scientist in International Regulatory Affairs. Gowri was responsible for preparing, reviewing, and submitting dossiers in support of biosimilars for monoclonal antibodies in various markets. Gowri also drafted and compiled technical packages for scientific advice meetings with regulatory authorities. At Biocon, they also worked as a Scientist in Research and Development from September 2011 to January 2014, where their focus was on microbial upstream process optimization, including handling and culturing of microbial cell banks, media and feed preparation/optimization.

Overall, Sukumar's work experience demonstrates their extensive expertise in CMC, regulatory affairs, and research in the pharmaceutical industry.

Gowri Sukumar has a diverse educational background in the field of biotechnology and related areas. In 2004, they obtained an Engineer's Degree from the Institute of Advanced Studies in Education, specializing in biotechnology. Following this, in 2008, they pursued a Fellowship in Clinical Research from the Apollo Hospitals Educational and Research Foundation (AHERF).

In 2009, Gowri Sukumar further expanded their knowledge by completing a Diploma in Proteomics for Basic Science and Applied Research at the Indian Institute of Science (IISc). During the same period, they also pursued an M.S (by Research) in Probiotics/Food Microbiology from the Vellore Institute of Technology.

In terms of additional certifications, Gowri Sukumar holds a Regulatory Affairs Certification (RAC) (Global) from the Regulatory Affairs Professionals Society (RAPS). The exact obtained month and year for this certification are not specified in the provided information.