Scientist Ii, Rsl

**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.-
- 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.-
- 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.-
- 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 an