Require Analytical Research & Development Scientist at USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Post : Scientist IV, Analytical Research & Development

Brief Job Overview
This is a non-supervisory position to support process development and scale-up of Active Pharmaceutical Ingredient (API) and related materials. The successful applicant in this role will work on projects including Analytical Method Development and evaluation for in-process samples for synthetic chemistry. The successful candidate will also perform a variety of non-routine and routine analytical tests, maintains safety & GLP environment in the lab including development/validation of methods, stability studies and research projects in analytical chemistry. The successful applicant will direct, troubleshoot, and share insights on complex projects while drawing independent conclusions about the results and determining how to proceed with the project. They closely collaborate with other scientists and/or other USP personnel.

Job Description
• Support reaction monitoring, scale-up and final analysis of samples as per monograph /in-house procedures including method development/validation if required. Prepare development reports for Synthetic Support projects. Execute projects per the approved test protocols if assigned.
• In collaboration with the synthetics team evaluate, implement and grow Process Analytical Technologies (PAT) capabilities and expertise. This includes evaluation of process monitoring, understanding, and control via in line, online and at line techniques. Serve as technical expert and champion for PAT and/or process model building.
• Plan, execute, and complete the projects as per specifications, timelines, and budget.
• Responsible for preparation and review of SOPs, protocols, reports, etc.
• Ensure project requirements by coordinating with external vendors and all internal relevant departments.
• Responsible for ensuring the required maintenance and calibrations of the equipment
• Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments as assigned
• Preparation and planning for ISO-9001 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
• Maintain GLP & implement safety procedures while working in Lab.
• Work on any other assigned tasks/ lab management activities.
• Conversant with lab safety norms and strictly follow them.
• Collaborate within the team and cross functional teams
• Learn and practice Diversity, Equity, Inclusion & Belonging culture

Candidate Profile
• Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience.
• Possess a fine understanding of USP/NF monographs/general chapters/general notices.
• Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.
• Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
• Good analytical skills in handling method development and Validations for Drug substances and Drug products.
• Should have exposure to GMP/GLP environment and documentation procedures.
• Awareness of ISO/IEC 17025 is desirable.

Additional Information
Experience : 8-10 years
Qualification : M.Pharm, MSc or PhD
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Compendial Development Laboratory
End Date : 31st August 2025