Scientist IV, Compendial Development Laboratory (Extractables and Leachables)

Description

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

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/General Chapters 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?

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

The Scientist IV has the following responsibilities:

• 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 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 (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience.
• Strong knowledge in designing, executing, and interpreting extractables and leachables studies for packaging systems, medical devices, and drug products.
• Familiarity with regulatory requirements for E&L in pharmaceutical and medical device sectors.
• Must have hands on experience in working with chemical methods and handling instruments like LC-MS, GC-MS.
• Strong expertise in mass spectrometry, including hands-on experience with HRMS, is required.
• Proficient in interpreting data using advanced mass spectrometry software tools.
• 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

Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration.

• Exceptional breadth of pharmaceutical industry experience.
• Excellent technical writing and oral communication skills required.
• Must be able to communicate effectively with diplomacy and enthusiasm.
• Hands on experience in working with chemical methods and handling instruments like HPLC, GC, FTIR, UV-Visible.
• Technical and analytical skills required including the ability to interpret technical information.
• Should have good understanding of GLP regulations and exposed to external regulatory audits.

Supervisory Responsibilities

None, this is an individual contributor role.

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.

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.