Scientist III, Analytical Research & Development(Prep HPLC)

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

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 Reference Standard Laboratory responsible for performing the required tests as part of the project and maintaining the GLP environment in the Laboratory. The incumbent will utilize his or her technical expertise, knowledge of pharmaceutical analysis in collaborative testing, efficient and effective laboratory operations.

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-III has the following responsibilities:

• Executes all testing and analysis of data with excellence and essentially no errors.
• Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing whenever needed.
• Responsible for sample archival, sample tracking and chemical inventory tracking in the laboratory.
• Coordination with supervisor to ensure completion of the projects allotted to the team.
• Completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis.
• Responsible for preparation and review of SOPs, protocols, reports etc.
• Responsible for performing the calibration of the equipment as per the schedule.
• Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
• Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
• Taking up any additional responsibilities assigned by Supervisor from time to time.
• Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
• Mentoring and training juniors in team for day-to-day analysis.

Note:

As part of the recruitment process, USP's Global Talent Acquisition team may contact candidates through a variety of communication channels, including Microsoft Teams, telephone, email, and WhatsApp (voice calls and text messages). These communications may be used to schedule interviews, provide updates on application status, discuss career opportunities, and answer questions about employment with USP.

To help ensure timely communication, candidates are encouraged to keep their contact information current and to engage only with individuals who clearly identify themselves as authorized USP representatives. USP will never request payment, banking details, or other financial information as part of the hiring process.

Fraud Alert:

USP is committed to protecting job seekers from recruitment fraud. Legitimate employment-related communications will come only from authorized USP representatives. If you are unsure whether a communication is authentic, please verify it through USP’s official careers website before sharing personal information.

Who USP is looking for?

The candidate must have strong analytical chemistry knowledge with the ability to analyze, interpret and report effectively on data from a variety of analytical instrumental tests (e.g., HPLC, GC, Wet analytical techniques, spectroscopic techniques). Well-developed organizational and interpersonal skills. Able to establish and nurture relationships with individuals of varying backgrounds, cultures and learning styles.

• Ph.D. in Chemistry or Master’s degree in chemistry / Pharmacy.

Experience:

• 1 to 3 years with relevant laboratory experience for Ph.D. candidates.
• 6 to 8 years with relevant laboratory experience for Master’s degree candidates.
• Proven track record of consistently delivering projects on time and with high quality for API’s and pharmaceutical dosage forms such as oral and liquid formulations.
• Expert in chromatographic analysis, particularly in HPLC & GC.
• Expertise in wet analytical techniques (Water determination, Loss on drying, Residue on Ignition, Titrations etc.,), spectroscopic analysis (UV, IR etc.,), HPLC & GC troubleshooting with Empower software strongly preferred.
• Knowledge of stability studies, pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP compendia, ICH guidelines, FDA regulations etc.).
• Must possess effective communication skills, both written and verbal.
• Expert in Empower software with knowledge on Audit trails and Custom fields.
• Must possess good technical and analytical skills to independently resolve or troubleshoot issues.
• Should have a strong understanding of GLP regulations and exposure to external regulatory audits.
• Awareness of GLP regulations, QMS, ISO/IEC 17025 and exposure to external regulatory audits is desirable.

Additional Desired Preference:

• Proven track record of consistently delivering projects on time and with high quality.
• Knowledge on other related analytical instrumentation (Thermal, Elemental analysis, LCMS, GCMS etc.) will be added advantage.
• Takes personal responsibility for delivery of projects to customers. Ability to support, lead change, extremely adaptable.
• Excellent communication skills, both written and verbal. Having knowledge of ELN, ERP, QR coding system are added advantages.
• Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.

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.