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

USP Brand; Hyderabad; On-site; INR 2,800,000 - 4,000,000; Full time

Job summary

USP India’s Analytical R&D Laboratory seeks a Sr. Scientist I to lead isolation and characterization work using prep HPLC, HPLC, and SFC. You will ensure GLP compliance, contribute to method development, and support QA/audit processes.

The role emphasizes accurate documentation, teamwork, and adherence to GMP standards to advance USP’s public health mission and scientific excellence.

Qualifications

• MSc in Analytical Chemistry / Organic Chemistry or M.Pharm with 11-13 years' experience in isolation & characterization.
• PhD with 7-10 years in isolation & characterization.
• Hands-on experience with Prep HPLC, SFC and HPLC; method development.
• GMP/GLP environment and documentation experience.
• Strong written and verbal communication; interaction with internal/external customers.
• Familiarity with electronic notebook documentation (ELN) is advantageous.

Responsibilities

• [60%] Execute the Isolation projects. Perform isolation/purification of known and unknown impurities/compounds by preparative HPLC and characterization using analytical techniques.
• [15%] Prepare, execute, and complete IQ/OQ/PQ of new instruments; procure glassware, chemicals and columns; maintain GLP and safety procedures.
• [10%] Prepare SOPs, protocols, reports; calibrations of equipment as per schedule; coordinate with Purchasing; maintain records.
• [10%] Participate in ISO-9001 certification/recertification; assist internal/external QA audits and address audit issues.
• [5%] Practice Diversity, Equity, Inclusion, and Belonging at USP India.

Skills

Analytical Chemistry

Isolation & Purification

Method development

GLP/GMP knowledge

Documentation

Communication

Problem solving

Education

MSc in Analytical Chemistry / Organic Chemistry

M.Pharm

PhD

Tools

Prep HPLC

SFC

HPLC

LCMS

GCMS

FTIR

NMR

UV-Visible

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.

Brief 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 technique.The successful candidate will also work on routine analytical tests, maintains safety & GLP environment in the lab and research projects in Analytical R&D department.

How will YOU create impact here at USP?

In this role at USP, 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. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Sr. Scientist I has the following responsibilities:

• [60%] Execute the Isolation projects. Carry out the isolation/ purification of known and unknown impurities/compounds by preparative HPLC and characterization of molecules using various analytical techniques. Involve in project acceptance.

• [15%] Prepare, execute, and complete IQ/OQ/PQ of new instruments. Indent the required glass ware, chemicals, and columns for the ARD projects. Maintain GLP & implement safety procedures while working in Lab. Perform other Projects whenever free from ARD activities. Perform other duties as assigned.

• [10%] Responsible for preparation of SOPs, protocols, reports, etc. Ensure the projects requirements by coordinating with the Purchasing department. Responsible for preparation of the records and documents. Ensure that the calibrations of the equipment’s are performed as per the schedule.

• [10%] Preparation and planning for ISO-9001 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner. Taking up any other additional responsibilities assigned by supervisor on a proactive basis and allotting additional responsibilities to the reporting staff in consultation with the supervisor. Participates in USP cross-functional teams as appropriate.

• [5%] 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:

• MSc. in Analytical Chemistry / Organic Chemistry/M. Pharm, having 11-13 years experience in Isolation and Charcterization or Ph.D. with 7-10 years of experience in Isolation and Charcterization.
• Must have hands on experience in working with chemical methods and handling instruments like Prep HPLC, SFC and HPLC. Expertise in HPLC,Prep HPLC and SFC method development and basic undersatnding in data interpretation of various analytical technique such as LCMS, GCMS, FTIR, XRD, UV-Visible, NMR etc is required.
• Experience in analytical testing and development with focus on process analytical chemistry. Exposure to GMP/GLP environment and documentation procedures required.
• A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
• Must be able to communicate effectively with both internal and external customers. Preferably familiar with electronic notebook documentation of experimental procedures.
• Must possess a strong work ethic and a solid record of problem solving and technical results.

Excellent technical writing and verbal communication skills are required.

• Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. Proven self-effectiveness skills are a must. Understanding of GMP / ISO-IEC 17025 Guidelines is a requirement

Additional Desired Preferences

• Knowledge on handling of TGA and DSC will be an added advantage.
• General chapter information, ELN, Empower and NuGenesis will be an added advantage.
• 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.

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.

Supervisory Responsibilities

NA

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 specificwritten agreement with USP.