The U.S. Pharmacopeial Convention (USP) 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 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Scientist II, RSL Stability
Job Overview
This is a key hands-on, non-supervisory position. In this role, the Scientist initiates and executes stability studies for reference standards using appropriate compendial methods. The Scientist will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical support and knowledge. The scientist has mastered many common techniques in the laboratory and can contribute their own observations and input to difficult projects. The incumbent will provide technical assistance to the Stability Program by performing analytical tests, reviewing analytical data, and preparing summary reports. The incumbent may execute 90% - 100% of their work at the bench level.
Job Description
• Demonstrates a solid scientific approach to analysis in the laboratory.
• Routinely applies personal experience, academic training, and technical insights – including emerging sciences – to solve complex technical problems within the laboratory.
• Drafts test protocols.
• Conducts stability testing for reference standard candidates using appropriate methods.
• Records experimental data, ensuring clear and accurate transcription of results and calculations.
• Prepares stability reports, evaluates chemical stability trends, and develops predictive stability models based on stability data.
• Completes the projects as per the project timelines and priorities.
• Compiles project reports and responds to QA observations.
• Executes all testing and analysis of data with excellence and essentially no errors.
• Demonstrates a strong desire to continue learning and grow personal capability.
• Pursues, recommends and implements new approaches or processes to improve laboratory operations.
• Positively influences project direction by ensuring own work is congruent with the overall direction of laboratory projects.
• Assists with other testing programs and housekeeping duties in the laboratory as needed.
• Prepares and reviews SOPs.
• Ensures the implementation of GLP, safety systems in labs.
• Ensures the calibration of the equipment as per the schedule.
• Indents chemicals, columns, Glassware, etc. and procures them by coordinating with lab operations and purchase department in advance keeping in mind the project deadlines.
• Ensures and follows USP mission, policies, and procedures.
• Maintains good relationships with HR, Purchase, accounting, IT, and other departments.
• Preparation and planning for ISO-9001 & ISO-17025 certification/recertification by participating actively and taking an active role in the internal as well as external QA audits and addressing the audit issues promptly.
• Supporting Collaborative testing, Verification, and other departmental teams in terms of project review, execution and approval whenever needed.
Candidate Profile
• The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviours and practices, and ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• MSc. in Chemistry / M.Pharmacy
• Between 5 to 7 years of relevant laboratory experience.
• Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical testing laboratory. Preferred requirements:
• Proven track record of consistently delivering projects on time and with high quality. Proficient with pharmaceutical testing requirements and test protocols involving compendial and non-compendial methods for APIs. (Having the Drug Products experience is an added advantage)
• Expert in Chromatographic analysis, especially in HPLC, GC and troubleshooting, proficient in other analytical techniques like Titrations, IR, KF, UV, Thermal, Elemental analysis etc.
• Knowing Empower software, Lab Management Systems and Electronic Laboratory Notebook, ERP, and QR coding systems are added advantages.
• Hands-on experience with stability chambers, daily monitoring and maintenance, annual PQs, handling of excursions and deviations, software handling according to the 21 CFR Part 11, long-term stability and transportation/shipping stability studies according to WHO and ICH.
• Takes personal responsibility for the delivery of projects to customers. Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal.
Additional Desired Preferences
• Functional Knowledge: Specific expertise, skills, and abilities required to deliver quality results.
• Problem-Solving: Applies advanced knowledge and expertise to solve complex challenges and deliver solutions within teams and across the organization.
• Innovation: Motivated to incorporate new ideas and thinking into everyday problems.
• Learning Agility: Driven to learn from every experience, applying insights across a variety of different situations to further understanding.
• Results Orientation: Consistently delivers on goals and deadlines while maintaining a high level of quality and accuracy.
• Risk Taking: Acts courageously while acting and making decisions aligned with goals and risk tolerance.
• Continuous Growth: Improves capabilities and performance on an ongoing basis by initiating and acting on development plans.
Additional Information
Experience : 5 to 7
Qualification : MSc. in Chemistry / M.Pharmacy
Location : Hyderabad
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 30th July, 2023
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