Scientist II, RSL (Stability)
Location: Hyderabad, India
Job Category: Chemistry & Scientific Standards
Job Type: Full-time
Req ID: SCIEN002701
Job Overview:
The Scientist II, RSL (Stability) plays a hands-on, non-supervisory role in executing stability studies for reference standards using appropriate compendial methods. The incumbent will also be responsible for analytical method development and validations for Impurity RS, maintaining a safe and compliant GLP environment. The scientist will contribute their technical expertise and knowledge to the laboratory, assisting with stability testing, reviewing data, preparing summary reports, and providing support to various teams.
Key Responsibilities:
Stability Testing & Reporting: Conduct stability testing, record data, evaluate trends, and develop stability models. Prepare detailed reports and execute testing with minimal errors.
Method Development & Validation: Develop and validate analytical methods using HPLC and GC, ensuring compliance with internal and external guidelines.
Experimentation & Project Planning: Design and execute experiments and validations, prepare protocols, and contribute to project planning.
Lab Operations & Improvement: Improve lab operations, align projects with laboratory goals, and ensure compliance with SOPs and GLP. Calibrate lab equipment as required.
Scientific Problem Solving: Solve complex scientific problems with a systematic approach, adhering to USP standards and preparing for ISO certifications.
Collaboration & Support: Support collaborative testing and work with various internal teams. Actively participate in continuous learning.
Qualifications:
Education & Experience:
Master’s in M.Sc. (analytical/organic) or M. Pharma (pharmaceutical sciences/analysis).
3-6 years of relevant experience in a pharmaceutical analytical laboratory.
Skills:
Expertise in pharmaceutical testing for APIs and formulations.
Proficiency in chromatographic systems, particularly HPLC and GC, including troubleshooting.
Skilled in wet chemical analysis (Titrations, IR, KF, UV, Thermal, Elemental analysis).
Experience with stability chamber management and conducting long-term and shipping stability studies in line with USP, WHO, and ICH guidelines.
Proficient in Empower software with knowledge of audit trails and custom fields.
Hands-on experience in analytical method development and validation.
Familiarity with lab management systems and electronic laboratory notebooks.
Additional Desired Preferences:
Knowledge of Lab Management System (LMS), Electronic Laboratory Notebook, ERP, and QR coding systems.
Experience with handling instruments like MS.
Familiarity with monograph procedures and participation in compendial methods for reference materials (USP, FCC, NF, etc.).
Previous experience in a high-volume pharmaceutical manufacturing QC lab or analytical R&D is a plus.
Awareness of ISO/IEC 17025 standards is desirable.
Benefits:
USP offers a comprehensive benefits package, including company-paid time off, healthcare options, and retirement savings, ensuring the well-being of employees and their families.
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