Sachin Gupta

About Sachin Gupta

CLINICAL SUPPLY PLANNING AND OPERATIONSPharmacist by education, with 20 years of Industrial Experience in various domains of Pharmaceutical Research and Development. Experienced in Project Management, People Management, end-to-end IMP Supply Management, Stakeholder Management, Employee training/mentoring, Process Improvement, Business Transformation and Business Transition projects.Core competencies include:Project Management • People Management • Change Management • Problem Solving • Process Improvement • Leadership • Decision Making • Analytical Thinking • GxP • Collaboration • Training • Mentoring

Experience

1. Deputy General Manager, Clinical Supply Operations Lead

   Viatris

   Jan 2022 — Present · Hyderabad, IN

   Handling key projects under challenging timelines and dynamic environment ensuring IMP supply deliverables meeting quality and timelines with zero stock out and no patient impact.• Technical assessment and selection of packaging, labeling, distribution and IRT vendors in collaboration with sourcing team.• Coordination of drug receipt, packaging, labeling, and distribution at contract packaging vendors.• Planning and oversight of end-to-end supply chain for assigned clinical trial projects.• Forecasting and ordering bulk drug, including comparators, for clinical trial projects.• Development of clinical supply plan and packaging design and periodic adaptation as needed.• Overseeing all the IMP related aspects of IRT system set-up through contracted IRT vendors including active involvement in URS review and UAT.• Ensure optimized budget forecasting for P&L vendor and comparator sourcing, budget adaptations, as needed, during conduct of clinical studies through intelligent spend across assigned portfolio.• Oversee supply logistics and inventory management through respective vendors.• Implement and oversee management of temperature excursion of study drugs for assigned portfolio.• Write and review the study medication sections of trial protocol.• Training of site staff and CROs on protocol procedures related to IMP handling.• Create, review, and revise global clinical supply SOPs.

Education

• Jamia Hamdard

  Master's Degree, M. Pharm. (Pharmacology)

  2003 — 2005

• Jamia Hamdard

  Bachelor's Degree, Pharmacy

  1999 — 2003

Skills

• Clinical Supplies
• Pharmaceutics
• Medical Writing
• Microsoft Office
• Clinical Research
• Ich-Gcp
• Training
• Mentoring
• CRO Management
• Supply Chain Management
• Clinical Development
• Therapeutic Areas
• Pharmacovigilance
• Regulatory Affairs
• Gmp
• Protocol
• Standard Operating Procedure (Sop)
• Clinical Trials
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Pharmaceutical Industry
• Sop
• CRO
• Gcp
• Good Clinical Practice (Gcp)