Rathnakar Nathi

An astute, meticulous, and competent individual with over 10 years of immense experience in the pharmaceutical industry encompassing various functions including formulation analytical method development and validation, and dossier submission to regulatory registration of FDA(USA), TGA(Australia), MHRA(Europe), NMPA(China), CDSCO (India) and WHO • Currently associated with Aarkish Pharmaceuticals NJ INC, NJ, U.S.A as Senior Quality Control Chemist • Secured Ph. D from Andhra University, A.P, India, stipulated in pharmaceutical sciences. • Strong leadership skills, team management expertise in the overall laboratory functions and frame the cGLP environment and facilitating total quality management and regulatory compliance. • Core research experience in formulation and analysis of solid dosage forms Tablets and Capsules (Immediate, Sustained, sublingual release), and injections (for injection to treat cancers) • Effective and confident scientific communicator both oral and written as evidenced by five peer reviewed publications and more than ten projects regulatory registered in the USA, MMPA, and Europe • Handling of CAPA, OOT, and OSS.

To conduct literature pharmacopeial monographs, ICH, and health authority regulatory requirements of generic dosage form, consider regulatory requirements to develop DOE and QbD approaches to optimize the analytical profile. • Conducted reverse engineering study on reference listed product quantification and identification of critical excipients and dose regimens by using HPLC- RI/ELSD coupled detectors. • Collaborative work with the formulator on dossier optimization, perform excipient ratio studies. • Mentored and supervised junior scientists in developing analytical methods and assisted in troubleshooting handling of HPLC, U.V, and Dissolution instruments.

Ph. D. (Pharmaceutical sciences), From Andhra University, India Tenure: 07/04/2018 to 29/08/2022- Par time course • Master of Pharmacy (Pharmaceutical Analysis and Quality Assurance), from Aditya Institute of Pharmaceutical science and technology, affiliated to Andhra University, A.P, India Tenure :11/11/2011 to 30/12/ 2013- Full time course. • Bachelor of Pharmacy from Lydia college of Pharmacy, affiliated to Andhra University, A.P, India. Tenure: 05/11/2007 to 30/04/2011- Full time course.