Scientist IV, Compendial Development Laboratory

Description

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.

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?

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.

• Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
• Apply technical and scientific expertise in analytical method development and validation of pharmaceuticals.
• Prepare and review the project plans, reports, laboratory notebook/ Laboratory management system (LMS) and compile project data as per requirement.
• Adhere to GLP and safety practices while working in the Lab.
• Practice Diversity, Equity, Inclusion, and Belonging principles at USP India.

Who USP is 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 (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience.
• 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 development and Validations for Drug substances and Drug products.
• Should have exposure to GMP/GLP environment and documentation procedures.
• Awareness of ISO/IEC 17025 is desirable.

Additional Desired Preferences

• Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience or Ph.D. with at least 4-7 years of experience in relevant field.
• Exceptional breadth of pharmaceutical 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.
• Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible.
• Should have good understanding of GLP regulations and exposed to external regulatory audits.

Supervisory Responsibilities

NA

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, 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 specific written agreement with USP.