BioSpace
Website:
biospace.com
Job details:
Description
Who is USP?
The U.S. Pharmacopeial Convention (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 1,300 hard-working 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 work—an 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 non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business, and the incumbent is expected to support monograph modernization initiatives.
How will YOU create impact here at USP?
In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, 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.
The Scientist-II Has The Following Responsibilities
- [15 %] Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
- [40 %] Apply technical and scientific expertise in analytical method development and validation of Small molecules and Food projects.
- [20 %] Prepare the project plans, reports, laboratory notebook/ Laboratory management system (LMS) and compile project data as per requirement.
- [15 %] Adhere to GLP and safety practices while working in the Lab.
- [10 %] Practice Diversity, Equity, Inclusion, and Belonging principles at USP India.
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
- Master’s Degree in Chemistry with 3-6 years of experience in relevant field..
- Possess a fine understanding of USP/NF monographs/general chapters/general notices.
- Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.
- Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
- Good analytical skills in handling method developments and validations for drug substance and drug products.
- Awareness of ISO/IEC 17025 is desirable.
Additional Desired Preferences
- Exceptional breadth of Pharma industry experience.
- Excellent technical writing and oral communication skills required.
- Must be able to communicate effectively with diplomacy and enthusiasm.
- Technical and analytical skills required including the ability to interpret technical information.
- Should have fair understanding of GLP regulations and exposed to external regulatory audits.
- Should possess strong technical knowledge in the areas of complex molecules, Drug substance, Drug products and different dosage forms.
Supervisory Responsibilities
NA
Benefits
USP provides the benefits 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.
Job Category Chemistry & Scientific Standards
Job Type Full-Time
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