Job Information
The U.S. Pharmacopeial Convention (USP) Scientist II, RSL Stability in Hyderabad, India
Description
. Brief 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.
How will YOU create impact here at USP?
The position's purpose should provide a high-level overview of why the position exists and briefly identify the most critical priorities of the position. This is an opportunity to highlight any features or duties of the role related explicitly to the Diversity, Equity, Inclusion & Belonging work of the Department.
Roles and Responsibilities:
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.
Who USP is Looking For? 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.
Supervisory Responsibilities: No
Benefits
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action, employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Chemistry & Scientific Standards
Job Type Full-Time