Amit Ghosh

About Amit Ghosh

With 12 years of extensive experience in the conduct and reporting of pharmacokinetic (PK) and toxicokinetic (TK) studies, I am a seasoned professional dedicated to advancing drug discovery and development.Currently, I lead a dynamic team of 10 study coordinators, document coordinators, and schedulers, overseeing all aspects of PK/TK analysis, reporting, and project management.My role includes coaching, mentoring, and developing staff to excel in their current roles and achieve their future aspirations through comprehensive in-job and skill development trainings.In my capacity, I independently perform study coordinator activities, ensuring strict compliance with protocols, standard operating procedures (SOPs), and regulatory guidelines.I also serve as a key point of contact for SEND-related activities and actively contribute as a CDISC volunteer.In my past experiences:* I functioned as a GLP study director to oversee development and routine employment of bioanalytical methods for the quantitative and qualitative analysis of small molecules in plasma, tissues, and other biological matrices, as well as, interpret and provide bioanalytical results in support of drug discovery and development.* Conducted pharmacokinetics and toxicokinetics studies for novel and generic small molecules as per regulatory requirements like GLP, OECD, FDA and ICH in a regulated setup.* Independently designed and executed experiments to quantitate molecular entities by LCMS-MS, TOF-MS and Thermo Exactive Orbitrap in support of both drug discovery and early development programs.* Reviewed operational and performance qualifications of equipments like LCMS-MS, HPLC, Thermo Exactive Orbitrap, Biomek, Tomtec Quadra and others.* Functioned as a member of the bioanalytical group and responsible for sample preparation, tissue homogenization, data generation and analysis with Analyst, Lightsight, Watson-LIMS and WinNonlin softwares.* Interacted with global clients/sponsors to discuss feasibility and timeline of projects and act as a link between sponsor and study team to move the study forward.

Experience

1. Supervisor, Pharmacokinetics and Toxicokinetics

   Labcorp

   May 2021 — Present · Bengaluru, IN

   Leading a team of 10 study coordinators, document coordinators and schedulers, responsible for PK/TK analysis and project management.Coach, mentor and develop staff to be successful in their current roles and future aspirations through in-job and skill development trainings.Independently perform study coordinator activities such as analysis of PK/TK data by Phoenix WinNonlin, and contribute to report writing which involves checking for compliance with protocol, SOPs and regulatory guidelines.Act as a point of contact and supervise SEND related efforts in the team.

Education

• Rajiv Gandhi University of Health Sciences

  Bachelor of Pharmacy (BPharm)

  2006 — 2010

• Rajiv Gandhi University of Health Sciences

  Master's degree

  2010 — 2012

Skills

• Glp
• Pharmacology
• Hplc
• Lc-Ms
• Clinical Trials
• Lifesciences
• Regulatory Affairs
• Sop
• Pharmaceutics
• Clinical Research
• Validation
• Pharmacovigilance
• Pharmacokinetics
• Chromatography
• Research
• Liquid Chromatography-Mass Spectrometry (Lc-Ms)
• Good Clinical Practice (Gcp)
• Biotechnology