The U.S. Pharmacopeial Convention (USP) is a globally recognized scientific organization dedicated to improving public health by establishing quality standards for medicines, dietary supplements, and food ingredients. With over 1,300 professionals across 20 global locations, USP ensures the safety and efficacy of pharmaceutical products worldwide. Their mission revolves around equity, excellence, and a passion for quality, making them a leader in pharmacopeial standards.
Job Title: Scientist IV, Analytical Research & Development
Location: Hyderabad, India
Industry: Pharma / Healthcare / Clinical Research
Functional Area: Compendial Development Laboratory
Experience: 8-10 years
Qualification: M.Pharm, MSc (Analytical/Organic Chemistry), or PhD
Last Date to Apply: 31st August 2025
Job Description
USP is seeking an Analytical R&D Scientist to support API process development, method validation, and analytical research. The role involves working in a GLP/GMP-compliant lab, ensuring data integrity, and contributing to Process Analytical Technologies (PAT).
Key Responsibilities:
✔ Method Development & Validation – Develop and validate analytical methods for drug substances & products as per USP/NF monographs.
✔ Process Analytical Technology (PAT) – Implement in-line, online, and at-line process monitoring techniques.
✔ Reaction Monitoring & Scale-Up – Support synthetic chemistry projects with HPLC, GC, spectroscopy, and other analytical techniques.
✔ Regulatory Compliance – Ensure adherence to GMP/GLP, ISO 9001, and data integrity norms.
✔ Instrumentation & Calibration – Manage IQ/OQ/PQ of lab equipment and maintain compliance.
✔ Documentation & Reporting – Prepare SOPs, test protocols, and technical reports.
✔ Lab Safety & Quality Systems – Maintain a safe, GLP-compliant work environment.
✔ Cross-Functional Collaboration – Work with synthetic chemists, QA, and regulatory teams.
Desired Candidate Profile
✅ Education: M.Pharm / MSc (Analytical/Organic Chemistry) / PhD with 8-10 years of experience.
✅ Technical Skills:
- Strong knowledge of HPLC, GC, UV-Vis, FTIR, NMR, Mass Spectrometry.
- Expertise in analytical method development & validation (ICH guidelines).
- Familiarity with USP monographs, GMP/GLP, and ISO 17025.
✅ Soft Skills: - Problem-solving, project management, and teamwork.
- Strong documentation and communication skills.
Why Join USP?
🔹 Global Impact – Contribute to public health & pharmaceutical quality standards.
🔹 Innovative Work Environment – Work with cutting-edge analytical technologies (PAT, spectroscopy, chromatography).
🔹 Career Growth – Opportunities in method development, regulatory compliance, and leadership roles.
🔹 Diversity & Inclusion – USP promotes an equitable and inclusive workplace.
How to Apply?
📅 Last Date: 31st August 2025
📍 Location: Hyderabad, India
