Biranchi Patra

Director of Research Development @Prolacta Bioscience

Los Angeles, CA, US

Developed innovative products from human milk and protected the IP (e.g. topical cream, bioactive including microRNAs, growth factors, stem cells, HMOs etc)•Played critical role to develop a nutritional product as a drug following ICH guidelines while ensuring quality, safety, and efficacy•Developed, Validated and Implemented QC testing methods as per ICH, USP, FDA and JP guidelines; wrote analytical method validations for CMC section and provided technical support for final submission of NDA to PMDA. •Collaborated with QC, Clinical Lab (CLIA), QA, QS, Manufacturing and RD for developing and validating new methods and improving the existing methods for operational excellence i.e. efficiency and effectiveness of methods•Provided direct support for CLIA lab certification with validation, implementation of method and automation of direct testing of donor milk samples with Hamilton Liquid handler•Provide scientific rationales to take business decisions on issues with bioanalytical operations adhering to Prolacta’s safety and quality standards•Knowledge and experience of compliances involving GLP/GMP inspections and audits by regulatory agencies including FDA, PMDA, NYSDOH, CDPH and others•3 Ps and Management style: People/Project/Place; Managing people and projects through collaboration with the cross-functional teams; coaching, supporting and providing the resources to the core team for successful completion of projects, mentoring the team for their career trajectory and excellence.•Prioritizing the projects based on urgency vs important with the end goal in mind i.e. aligning with Prolacta’s growth and supporting the initiatives for US and international markets•Connectedness (Considerate, caring, accepting and thoughtfulness) and Maximizer (develop, refine, stretch and pursue for excellence): These core strengths have helped me build a high performing team to provide tactical solutions for high quality, purity and safety products at Prolacta

Indian Agricultural Research Institute, India

Master’s Degree, Molecular Biology and Biotechnology

Keck Graduate Institute, Masters in Bioscience Management

Master of Business Administration (M.B.A.), Biotech Management (Business strategy and Regulatory Affairs)

The University of Melbourne, Australia

Doctor of Philosophy (Ph.D.), Genetics and Plant Molecular Biology

Banaras Hindu University, Varanasi, India

Bachelor’s Degree, Genetics and Agriculture