Location: Hyderabad, India
Industry Type: Pharma/Healthcare/Clinical Research
Functional Area: RSL (Stability)
Experience: 3-6 years
Qualification: M.Sc. (Analytical/Organic Chemistry) or M.Pharma (Pharmaceutical Sciences/Analysis)
Application End Date: 20th May 2025
About U.S. Pharmacopeial Convention (USP)
The U.S. Pharmacopeial Convention (USP) is a leading global scientific organization dedicated to improving public health by setting quality standards for medicines, dietary supplements, and food ingredients. With a workforce of over 1,300 professionals across 20 global locations, USP ensures the safety and efficacy of pharmaceutical products worldwide. Their mission is to strengthen the supply of high-quality, safe medicines through scientific excellence and innovation.
Job Description: Scientist II, RSL (Stability)
Key Responsibilities:
- Conduct stability testing for reference standards using compendial methods.
- Perform analytical method development and validation for Impurity Reference Standards (RS).
- Ensure compliance with GLP (Good Laboratory Practices) and maintain a safe lab environment.
- Execute HPLC, GC, and wet chemical analysis (Titrations, IR, KF, UV, Thermal, Elemental analysis).
- Manage stability chambers and monitor long-term/shipping stability studies per USP, WHO, and ICH guidelines.
- Prepare technical reports, protocols, and SOPs while ensuring data integrity.
- Troubleshoot chromatographic systems and utilize Empower software (Audit Trails, Custom Fields).
- Support ISO/IEC 17025 compliance and lab accreditation processes.
- Collaborate with cross-functional teams for method transfers and collaborative testing.
Required Skills & Qualifications:
- Education: M.Sc. (Analytical/Organic Chemistry) or M.Pharma (Pharmaceutical Analysis).
- Experience: 3-6 years in pharmaceutical analytical testing (API/Formulations).
- Technical Expertise:
- HPLC, GC, MS (added advantage)
- Stability studies (ICH, WHO guidelines)
- Method development & validation
- Lab Management Systems (LMS), Electronic Lab Notebooks
- Soft Skills: Strong communication, problem-solving, adaptability, and leadership in process improvements.
Preferred Qualifications:
- Experience with ERP systems, QR coding, and ISO 17025.
- Knowledge of USP, FCC, NF monographs.
- Background in Analytical R&D, QC, or Contract Pharma Labs.
How to Apply?
Interested candidates meeting the eligibility criteria can apply before the deadline of 20th May 2025.