Sr Scientist I/ Sr. Scientist II, Documentary Standards (Excipients)

US Pharmacopeia; Hyderabad; On-site; INR 6,704,980 - 9,578,544; Full time

Benefits offered by this job

Company-paid time off

Comprehensive healthcare options

Retirement savings plans

Job summary

US Pharmacopeia is seeking a Senior Scientist I/II in Hyderabad, India, to support the Excipients program unit. This role involves developing high-quality excipient monographs and participating in collaborative initiatives across global teams.

The ideal candidate has a Ph.D. or MS in Chemistry with extensive experience in analytical chemistry, project management, and excellent communication skills. USP offers a full-time position with comprehensive benefits, emphasizing passion for quality in public health.

Qualifications

• Ph.D. with 7-10 years of relevant experience or MS with 11-13 years.
• Experience in excipient composition and analytical chemistry.
• Outstanding communication skills in English.

Responsibilities

• Work with USP staff on excipient monograph development.
• Prepare data packages and briefing materials.
• Participate in scientific conferences and USP meetings.

Skills

Excipient composition

Analytical chemistry

HPLC

GC

LC/MS

Project management

Communication skills

Education

Ph.D. in Organic Chemistry, Analytical Chemistry, Biochemistry

MS in relevant field

Job description

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. USP believes that scientific excellence is driven by fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high‑quality medicines worldwide.

Brief Job Overview

This is a professional, highly technical, non‑supervisory position that supports the Excipients program unit team (PUT) within USP’s Global Science and Standards Division (GSSD). The incumbent reports to a local management position at the India site and functionally reports to a management position in the Excipients PUT in the US. Responsibilities include supporting the development and technical stewardship of NF standards, excipient monographs, and associated reference standards, as well as outreach, awareness, and internal strategic initiatives. The incumbent will apply technical expertise, knowledge of compendial monograph development, and strong organizational and communication skills to ensure timely development of high‑quality monographs and reference standards. The Science EXC PUT works closely with multiple departments such as Strategic Customer Development, Standard Acquisition, Compendial Operation, Global Laboratory Operations, Regions Program Operation, and Global External Affairs.

How you will create impact at USP

As part of our mission to advance scientific rigor and public health standards, you will increase 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 worldwide health systems can rely on strong, tested, and globally relevant quality standards.

The Senior Scientist I/II Responsibilities

• Work with USP staff, relevant USP Excipient Expert Committee(s), subcommittees, and external stakeholders related to excipient monograph and reference standard development.
• Prepare data packages and briefing materials for the Excipients EC/SC/EP; manage projects and ensure impeccable work‑product delivery.
• Participate in USP EC/SC/EP meetings, scientific conferences, outreach visits, and other events sponsored by USP, the pharmaceutical industry, trade associations, and regulatory agencies.
• Standard‑setting responsibilities: prepare summary packages, briefing materials, and other technical documents for correspondence with EC/CS/EP; manage action items from monthly EC/SC/EP telecom meetings; track and report assignment status; facilitate key departmental metrics; assist in manuscript writing for USP publications; apply knowledge of current public‑health trends to prepare information for Expert Committee decision‑making; perform related duties as assigned.

Qualifications

• Ph.D. in Organic Chemistry, Analytical Chemistry, Biochemistry, or allied field with 7‑10 years of relevant experience (Scientist I); MS with 11‑13 years of relevant experience.
• Ph.D. with 10‑13 years of relevant experience (Scientist II); MS with 13‑15 years of relevant experience.
• Experience with excipient composition, quality, or analytical chemistry; outstanding written and verbal communication skills in English.
• Ability to review, analyze, and interpret data from analytical tests such as HPLC, GC, LC/MS, GC/MS, IR, Raman, UV‑Vis, NMR, ICP‑MS, and AA.

Additional Desired Preferences

• Strong technical knowledge of complex molecules/compounds such as polymers, fats, oils, waxes, and plant materials.
• Ability to communicate technical information to non‑technical staff and external partners; rapid identification and resolution of technical issues.
• Well‑developed organizational, interpersonal, negotiation, writing, listening, and presentation skills.
• Proficient with pharmaceutical testing requirements and USP‑NF compendial method development for excipient monographs.
• Ability to influence without direct authority.
• Results‑driven with successful outcomes.
• Project management skills and ability to prioritize tasks and manage multiple projects simultaneously.
• Independent work with appropriate escalation and effective partnership building.
• Ability to work well with diverse employees and customers in a cooperative, friendly manner.
• Ability to handle multiple priorities in a fast‑paced environment.
• Flexible work hours when needed.
• Prior experience in a scientific‑based industry.
• Excellent written and verbal communication skills.

Supervisory Responsibilities

None; this is an individual contributor role.

Benefits

USP provides comprehensive benefits to protect you and your family today and tomorrow, including company‑paid time off, comprehensive healthcare options, and retirement savings plans.

Job Category: Chemistry & Scientific Standards

Job Type: Full‑Time