Senior Scientist I, Analytical Research & Development - Prep HPLC/ SFC

US Pharmacopeia; Hyderabad; On-site; INR 1,000,000 - 2,000,000; Full time

Benefits offered by this job

Company-paid time off

Comprehensive healthcare options

Retirement savings

Job summary

US Pharmacopeia in Hyderabad seeks a Senior Scientist for its Analytical R&D Laboratory. You will perform isolation and characterization of compounds, maintain lab safety, and contribute to public health improvements.

Ideal candidates will have an MSc or Ph.D. with extensive experience in analytical chemistry and instrumental techniques. The position supports professional growth and offers comprehensive benefits.

Qualifications

• 11-13 years of experience in isolation and characterization or Ph.D. with 7-10 years.
• Experience in analytical testing with a focus on process analytical chemistry.
• Understanding of GMP/ISO-IEC 17025 Guidelines required.

Responsibilities

• Execute isolation/purification of known and unknown impurities.
• Prepare and complete IQ/OQ/PQ of new instruments.
• Maintain GLP and implement safety procedures.
• Prepare SOPs and ensure calibrations of equipment.
• Participate in audits for ISO-9001 certification.

Skills

Hands-on experience with chemical methods and instruments

Effective communication

Technical writing

Problem-solving

Teamwork

Education

MSc in Analytical Chemistry, Organic Chemistry, or M. Pharm

Ph.D. in relevant field

Tools

Prep HPLC

LCMS

GCMS

FTIR

NMR

Job description

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

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—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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 for individuals with disabilities.

Job Overview

This is a non supervisory position in USP-India’s Analytical Research & Development Laboratory. In this role, the S‑IV/Senior Scientist‑I will work on isolation/purification of known and unknown impurities/compounds by preparative HPLC and characterization of molecules using various analytical techniques. The successful candidate will also perform routine analytical tests, maintain a safety & GLP environment in the lab, and work on research projects in the Analytical R&D department.

Impact

In this role, you contribute to USP’s public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. You will also support the company’s commitment to professional development, inclusive management training, and a productive work environment.

Responsibilities

• Execute isolation projects (60%): carry out isolation/purification of known and unknown impurities/compounds by preparative HPLC and characterize molecules using various analytical techniques. Involve in project acceptance.
• Prepare, execute, and complete IQ/OQ/PQ of new instruments (15%): indent required glassware, chemicals, and columns for ARD projects. Maintain GLP and implement safety procedures while working in the lab. Perform other projects whenever free from ARD activities and other duties as assigned.
• Prepare SOPs, protocols, reports, etc. (10%): ensure project requirements by coordinating with the purchasing department. Prepare records and documents. Ensure calibrations of equipment are performed as scheduled.
• Prepare and plan for ISO‑9001 certification/recertification (10%): participate in audits, verify protocols and documents, address audit issues, and take on any additional responsibilities assigned by supervisor.
• Practice Diversity, Equity, Inclusion, and Belonging principles at USP India (5%).

Qualifications

• MSc in Analytical Chemistry, Organic Chemistry, or M. Pharm with 11‑13 years of experience in isolation and characterization, or Ph.D. with 7‑10 years of experience.
• Hands‑on experience with chemical methods and instruments such as Prep HPLC, SFC, and HPLC; expertise in method development and data interpretation of LCMS, GCMS, FTIR, XRD, UV‑Visible, NMR, etc.
• Experience in analytical testing and development with a focus on process analytical chemistry. Exposure to GMP/GLP environment and documentation procedures.
• Comprehensive understanding of the science involved in developing synthetic organic molecules and analytical chemistry.
• Effective communication with internal and external customers; familiarity with electronic notebook documentation.
• Strong work ethic, record of problem solving and technical results.

Excellent technical writing and verbal communication skills are required. Good interpersonal skills, proven ability to function in a team-oriented environment, and self‑effectiveness are essential. Understanding of GMP / ISO‑IEC 17025 Guidelines is required.

Additional Desired Preferences

• Knowledge of handling TGA and DSC.
• Experience with ELN, Empower, and NuGenesis.
• Skill at evaluating and interpreting data; ability to multitask.
• Skill at anticipating, troubleshooting, and solving technical problems.
• Personal responsibility to ensure work is delivered on time and at high quality.

Supervisory Responsibilities

NA

Benefits

USP provides 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 Category: Chemistry & Scientific Standards

Job Type: Full‑Time