Scientist II RSL Stability
Scientist II RSL Stability
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Job Description
Who is USP
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top authorities in health and science to develop quality standards for medicines dietary supplements and food ingredients. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1300 hardworking professionals across twenty global locations to deliver the mission to strengthen the supply of safe quality medicines and supplements worldwide.
At USP we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build and the conversations we foster we affirm the value of Diversity Equity Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare.
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 workan environment where every employee feels fully empowered and valued irrespective of but not limited to 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.
Brief Job Overview
This is a key handson nonsupervisory position. In this role the Scientist initiates and executes stability studies for reference standards using appropriate compendial methods. Additionally the incumbent will be responsible for performing analytical method development and validations for Impurity RS and maintaining safety and GLP environment in the lab. 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
In this role at USP you contribute to USPs public health mission of increasing equitable access to highquality safe medicine and improving global health through public standards and related programs. In addition as part of our commitment to our employees Global People and Culture in partnership with the Equity Office regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.
- Conducts stability testing and records data.
- Prepares reports evaluates trends and develops models.
- Executes testing with minimal errors.
- Completes projects on time and responds to QA.
- Experienced in method development and validation using HPLC and GC.
- Designs and executes experiments and validations.
- Prepares protocols and engages in project planning.
- Improves lab operations and aligns projects with goals.
- Prepares SOPs ensures GLP and calibrates equipment.
- Solves complex problems with scientific approach.
- Follows USP standards and prepares for ISO certifications.
- Supports collaborative testing and other teams.
- Committed to continuous learning.
Who is USP Looking For
The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:
- Education: Masters in M.Sc. (analytical/organic) or M. Pharma (pharmaceutical sciences/analysis).
- Experience: 36 years relevant experience in pharmaceutical analytical laboratory.
- Skills:
- Pharmaceutical testing for APIs and Formulations.
- Chromatographic systems (HPLC GC) handling and troubleshooting.
- Expert in Empower software with knowledge on Audit trails and Custom fields.
- Wet chemical analysis (Titrations IR KF UV Thermal Elemental analysis).
- Stability chambers management and monitoring.
- Longterm and shipping stability studies per USP internal guidelines and WHO ICH guidelines.
- Analytical method development and validation.
- Lab management systems and electronic laboratory notebooks.
- Attributes: Excellent communication highly responsible adaptable and capable of leading change.
Additional Desired Preferences
- Having knowledge of Lab Management System (LMS) and Electronic Laboratory Notebook ERP QR coding system is an added advantage.
- Handson experience in handling instruments like MS is an added advantage.
- Understanding monograph procedures and participating in compendial methods for reference materials (USP FCC NF etc..
- Prior experience in a highvolume pharmaceutical manufacturing QC laboratory or Analytical R&D or a contract pharmaceutical analytical laboratory testing organization is a plus.
- Awareness of ISO/IEC 17025 is desirable.
Supervisory Responsibilities
No
Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.
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 specificwritten agreement with USP
Employment Type
Full-Time
