Scientist IV, Analytical Research & Development

US Pharmacopeia; Hyderabad; On-site; INR 7,626,310 - 9,532,888; Full time

Benefits offered by this job

Comprehensive healthcare options

Retirement savings

Paid time off

Job summary

US Pharmacopeia in Hyderabad is seeking an experienced Analytical Chemistry professional to support process development for Active Pharmaceutical Ingredients. The role involves analytical method development, project management, and collaboration within teams to enhance public health standards.

Successful candidates will have substantial experience in analytical research, with a hands-on approach to chemical instrumentation and method validation. USP offers competitive benefits and values diversity, equity, and inclusion in the workplace.

Qualifications

• 8-10 years of experience in Analytical Research and Development.
• Experience in analytical testing and development.
• Ability to collaborate effectively in team-oriented environments.

Responsibilities

• Support reaction monitoring and analysis of samples as per protocols.
• Plan and execute projects according to specifications and timelines.
• Collaborate with cross-functional teams.

Skills

Hands-on experience with chemical methods and instruments (HPLC, GC, LC-MS)

Technical writing and verbal communication skills

Interpersonal skills

Analytical method development

Education

B.Sc./M.Pharm with 8-10 years of experience or Ph.D. with 4-7 years

Tools

HPLC

GC

LC-MS

GC-MS

FTIR

UV-Visible

Job description

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 to support process development and scale‑up of Active Pharmaceutical Ingredient (API) and related materials. The successful applicant will work on projects including Analytical Method Development and evaluation for in‑process samples for synthetic chemistry, perform a variety of non‑routine and routine analytical tests, maintain a safety & GLP environment in the lab, and participate in development/validation of methods, stability studies, and research projects in analytical chemistry. The successful applicant will direct, troubleshoot, and share insights on complex projects while drawing independent conclusions and determining how to proceed, collaborating closely with other scientists and USP personnel.

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, including training in equitable management practices and tools to promote engaged, collaborative, and results‑driven work environments.

Responsibilities

• Support reaction monitoring, scale‑up, and final analysis of samples as per monograph/in‑house procedures, including method development/validation if required. Prepare development reports for Synthetic Support projects. Execute projects per the approved test protocols if assigned.
• Plan, execute, and complete projects according to specifications, timelines, and budget.
• Prepare and review SOPs, protocols, reports, etc.
• Ensure project requirements by coordinating with external vendors and all internal relevant departments.
• Maintain equipment, perform required maintenance and calibrations.
• Prepare, execute, and complete IQ/OQ/PQ of new instruments as assigned.
• Participate actively in ISO‑9001 certification/recertification, verify protocols and related documents, and address audit issues in a timely manner.
• Maintain GLP and implement safety procedures while working in the lab.
• Perform any other assigned tasks and lab management activities.
• Follow laboratory safety norms strictly.
• Collaborate within the team and with cross‑functional teams.
• Practice Diversity, Equity, Inclusion & Belonging culture.

Qualifications

• Sc. in Analytical Chemistry / Organic Chemistry / M. Pharm with 8‑10 years of experience in Analytical Research and Development, or Ph.D. with 4‑7 years of experience in the same.
• Hands‑on experience with chemical methods and instruments such as HPLC, GC, LC‑MS, GC‑MS, FTIR, UV‑Visible, wet chemistry, etc.
• Experience in analytical testing and development focusing on process analytical chemistry to understand, monitor, and control chemical processes/reactions.
• Comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
• Ability to perform analytical method development and method validation as required.
• Excellent technical writing and verbal communication skills.
• Good interpersonal skills and proven ability to function in a team‑oriented environment.

Additional Desired Preferences

• Understanding of process analytical technology, chemometrics, and knowledge of in‑line, online, at‑line process analytical tools (e.g., IR, Raman, HPLC).
• Evaluation of process monitoring, understanding, and control via in‑line, online, and at‑line techniques; serve as technical expert and champion for PAT and/or process model building.
• Experience with a wide variety of software and laboratory information systems, including chemometric modeling software.
• Working knowledge of API manufacturing and product testing (e.g., ICH guidelines, USP general chapters and monographs).
• Expertise with USP compendial methods and requirements (e.g., monographs and general chapters) and ICH quality guidelines.
• Pharmaceutical laboratory experience, method development and implementation in manufacturing environments, and/or continuous manufacturing experience.
• Strong project management skills with ability to be effective independently and in collaborative teams.
• Skilled in evaluation and interpretation of data; ability to multi‑task.
• Skilled in anticipating, troubleshooting, and solving technical problems.
• Takes personal responsibility to ensure work is delivered on time and is of the highest quality.

Benefits

USP provides the benefits to protect you 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 Details

Only listed for USA job opportunities.

Base Salary Range: USD $[XX,XXX – XX,XXXX] annually.

Target Annual Bonus: Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job‑related reasons.

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.

Job Category: Chemistry & Scientific Standards

Job Type: Full‑Time