Director of Analytical and Formulation Sciences
Greater Philadelphia Area
Associate Director: Method Development and Validations
February 2015 to September 2018
Section Leader-Late Stage Analytical Characterization Biologics
August 2011 to January 2014
Patheon Biologics part of ThermoFisher Scientific
Director of Analytical and Formulation Sciences
Princeton, New Jersey
Actinium Pharmaceuticals, Inc.
Director Bioprocess Development
January 2014 to February 2015
Greater New York City Area
Schering-Plough Research Institute
Senior Scientist: Commercial Process Development
January 2008 to August 2011
Led a large team responsible for development and pre-validation of separation analytical methods for therapeutic proteins (mAbs, ADCs, and combination products) in early and late stage. Engaged with commercial analytical organization for supporting technology transfer and validation activities for late-stage programs (Opdivo and Empliciti) . Led platform method development activities to achieve fast to FIH timelines with... Led a large team responsible for development and pre-validation of separation analytical methods for therapeutic proteins (mAbs, ADCs, and combination products) in early and late stage. Engaged with commercial analytical organization for supporting technology transfer and validation activities for late-stage programs (Opdivo and Empliciti) . Led platform method development activities to achieve fast to FIH timelines with well defined methods. Interfacing with process development teams to address analytical methods and strategy for PD. Engaged in coaching, mentoring, and motivating team members to integrate individual development and group dynamics.
What company does Amit Katiyar work for?
Amit Katiyar works for Bristol-Myers Squibb
What is Amit Katiyar's role at Bristol-Myers Squibb?
Amit Katiyar is Associate Director: Method Development and Validations
What industry does Amit Katiyar work in?
Amit Katiyar works in the Biotechnology industry.
💼 Past Experience
Amit Katiyar has both technical and leadership experience in bioprocess development and supply chain management, both at the research and commercial levels. Amit Katiyar's work experiences include leading teams inJV biochemistry (cubes, recombinant proteins, Phase I, Phase II, and III studies), analytical and process development for commercial biologics, and developing purification processes for phase III and commercial manufacturing. In his most recent role, Amit Katiyar led a team of scientists who designed and executed scientific research projects for purification development and manufacturing of biosimilars and novel biologics.Amit Katiyar has a Master's degree in chemistry from Columbia University and a doctorate in chemistry from the University of Pennsylvania. He has over 10 years of experience in analytical and process development, most recently working in product development for JV biochemistry. Amit Katiyar is currently an Associate Director at Bristol-Myers Squibb, where he leads a team responsible for development and pre-validation of separation analytical methods for therapeutic proteins (mAbs, ADCs, and combination products). Amit Katiyar was also a lead scientist at Patheon Biologics, where he was responsible for developing and pre-validating separation analytical methods for protein characterization, new technology, and formulation development supporting bioprocess development and global GxP operations. Amit Katiyar also has experience in coaching, mentoring, and motivating team members to integrate individual development and group dynamics.Since joining Actinium Pharmaceuticals in February 2015, Amit Katiyar has been working as a Section Leader-Late Stage Analytical Characterization Biologics at Merck. Amit Katiyar led a team of scientists who supported analytical development for Phase III/commercial biologics at Actinium Pharmaceuticals, Inc. as well as developing key regulatory submissions (IND amendments, BLAs, briefing books) and authority interactions in F2F meetings. As a part of his responsibilities, Amit Katiyar prepared and managed timelines for process development, manufacturing, quality, regulatory strategies in readiness for BLA submission. Amit Katiyar is also a senior scientist at Schering-Plough Research Institute, where he designed and executed scientific research projects for purification development and manufacturing of biosimilars and novel biologics.Amit Katiyar's experience and skills provide aample of how leaders can work together to help achieve successful product launches. Leaders can work with their teams to develop a plan that incorporates the needs of the team and theSpecific needs of the customer. By working together, team members can improve the overall success of a product launch by ensuring that all members are participating in the process and that everyone is working towards a common goal.
Amit Katiyar has a Doctorate in Chemical and Materials Engineering from the University of Cincinnati, and a BTech in Biochemical Engineering from Harcourt Butler Technical University. Amit has also holds a Master of Technology in Chemical Engineering from Indian Institute of Technology, Delhi.
💡 Technical & Interpersonal Skills
Skills and experience Amit Katiyar brings to the table:Project Management, stood up to projects when others FailedAmit Katiyar has a long record of successfully partnering with other teams in order to deliver results. He has stood up to projects when others failed and ensure that every project is completed on time and within budget. Amit Katiyar is also a highly effective communicator and has a knack for turning difficult challenges into a successful outcome.Technical Expertise:Amit Katiyar possessing a strong technical background has the ability to develop and implement effective technology transfer projects. He is also an expert in protein characterization, new technology, and formulation development.Personal qualities:Amit Katiyar is a highly dedicated individual who is always willing to help others succeed. He is highly comfortable working in a team environment and is an excellent motivator. He is also highly resourceful and is able to find ways to improved the working efficiency of his team.
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
2 year(s), 9 month(s)
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