Scientist I, Verification Program at USP
Company: U.S. Pharmacopeial Convention (USP)
Location: Hyderabad, India
Position: Scientist I, Verification Program
Job Type: Full-Time
Application: Apply Now
Description: USP is an independent scientific organization that collaborates with global health and science experts to develop quality standards for medicines, dietary supplements, and food ingredients. USP is dedicated to ensuring safe and quality medicines and supplements worldwide through its core value of Passion for Quality, upheld by over 1,100 professionals across five global locations.
Brief Job Overview: This non-supervisory role involves conducting analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) using suitable methods. The Scientist will enhance the laboratory’s proficiency by offering technical support and knowledge, providing valuable insights into challenging projects, and preparing comprehensive summary reports.
Key Responsibilities:
- Conduct Verification projects (Dietary supplements/Dietary Ingredients) by performing analytical tests assigned by the Team Leader.
- Complete projects within designated timelines and priorities.
- Demonstrate a robust scientific approach to laboratory analysis.
- Utilize experience, academic training, and technical insights to address complex technical issues within the laboratory.
- Compile project reports and respond to QA observations.
- Execute all testing and data analysis with precision, minimizing errors.
- Show a strong commitment to continuous learning and personal development.
- Propose and implement new approaches to enhance laboratory operations.
- Influence project direction positively by aligning work with the overall direction of laboratory projects.
- Assist with additional testing programs and laboratory maintenance tasks as required.
- Ensure compliance with Good Laboratory Practices (GLP) and safety systems.
- Maintain equipment calibration according to schedule.
- Coordinate procurement of chemicals, columns, glassware, etc., in advance, in coordination with lab operations and the purchase department.
- Adhere to USP mission, policies, and procedures.
- Cultivate positive relationships with Quality Assurance (QA), Human Resources (HR), Purchase, Accounting, IT, and other departments.
- Participate in preparation and planning for ISO-9001 & ISO-17025 certification/recertification, including internal QA and external audits, and addressing audit issues promptly.
- Support Global Public Health (GPH), Reference Standard Laboratory (RSL), and other departmental teams as required for analytical testing, review, execution, and approval.
Candidate Profile:
- Education: Master’s degree in pharmacy or analytical chemistry.
- Experience: 1-3 years of relevant laboratory experience, specifically in pharmaceutical dosage forms such as oral and liquid in a high-volume pharmaceutical manufacturing QC laboratory or a contract pharmaceutical analytical testing laboratory.
Additional Desired Preferences:
- Proficiency in leading projects to completion with a high level of scientific expertise.
- Extensive knowledge of pharmaceutical testing requirements and test protocols, including compendial methods (USP, BP, EP, etc.).
- Expertise in HPLC/GC operation with Empower software, and proficiency in ICP-OES, ICP-MS, LC-MS, and dissolution analysis with troubleshooting abilities.
- Proficiency in operating and troubleshooting other related analytical instrumentation (IR, KF, UV, etc).
- Exceptional communication and presentation skills.
- Familiarity with ICH guidelines and FDA regulations, along with experience in compendial procedures and compliance.
- Proficiency in Electronic Laboratory Notebook (ELN) preferred.
- Personal commitment to ensuring timely delivery of high-quality work, with skills to anticipate, troubleshoot, and resolve technical challenges.
Supervisory Responsibilities:
- None
Benefits: USP provides comprehensive benefits to protect personal and financial wellbeing, including company-paid time off, healthcare options, and retirement savings.