Scientist II, Verification Programs

BioSpace; Chittoor; On-site; INR 600,000 - 900,000; Full time

Job summary

USP in India seeks a Scientist for analytical testing of Verification samples (dietary supplements/ingredients). You will support QA by preparing detailed reports, ensuring GLP compliance, and maintaining laboratory safety.

The role develops technical proficiency and contributes to ISO certifications through rigorous testing and data analysis. Ideal candidates hold a Master’s in Pharmacy or Analytical Chemistry with 3–6 years of lab experience in a high-volume QC setting, and are proficient with

Qualifications

• Master’s degree in pharmacy or analytical chemistry required.
• 3–6 years of relevant lab experience in pharmaceutical QC.
• Experience with HPLC (Empower) and dissolution analysis.
• Excellent written and verbal communication; strong problem-solving skills.

Responsibilities

• Perform analytical tests on Verification samples (dietary supplements/ingredients).
• Prepare comprehensive summary reports and QA documentation.
• Ensure GLP compliance and safety in the laboratory.

Skills

Communication skills

Analytical skills

Troubleshooting

GLP awareness

Education

Master’s degree in Pharmacy or Analytical Chemistry

Tools

Empower HPLC software

Dissolution testing equipment

Job description

Description

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

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 to individuals with disabilities.

Brief Job Overview

This is non-supervisory role involves conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) utilizing suitable methods. The Scientist will enhance the laboratory's scientific proficiency and work ethic by offering extensive technical support and knowledge. Proficient in numerous common laboratory techniques, the Scientist is capable of providing valuable observations and insights into challenging projects. The individual in this role will furnish technical aid to the Verification Program by executing analytical tests and preparing comprehensive summary reports.

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.

• Conducts Verification projects (Dietary supplements/Dietary Ingredients) by performing individual analytical tests assigned by the Team Leader.
• Completes projects within designated timelines and priorities.
• Demonstrates a robust scientific approach to laboratory analysis.
• Regularly utilizes personal experience, academic training, and technical insights, including emerging sciences, to address complex technical issues within the laboratory.
• Compiles project reports and responds to QA observations.
• Executes all testing and data analysis with precision, minimizing errors.
• Shows a strong commitment to continuous learning and personal development.
• Proposes and implements new approaches or processes to enhance laboratory operations.
• Influences project direction positively by aligning own work with the overall direction of laboratory projects.
• Assists with additional testing programs and laboratory maintenance tasks as required.
• Ensures compliance with Good Laboratory Practices (GLP) and safety systems in the laboratory.
• Maintains equipment calibration according to the schedule.
• Coordinates the procurement of chemicals, columns, glassware, etc., in advance, in coordination with lab operations and the purchase department, considering project deadlines.
• Adheres to US Pharmacopeia (USP) mission, policies, and procedures.
• Cultivates positive relationships with Quality Assurance (QA), Human Resources (HR), Purchase, Accounting, IT, and other departments.
• Participates actively in the preparation and planning for ISO-9001 & ISO-17025 certification/recertification, including taking an active role in internal QA and external audits and addressing audit issues promptly.
• Supports Global Public Health (GPH), Reference Standard Laboratory (RSL), and other departmental teams as required for analytical testing, review, execution, and approval

Who is USP Looking For?

• Master’s degree in pharmacy or Analytical chemistry.
• Minimum 3 to 6 years with relevant laboratory experience.
• Previous engagement in a high-volume pharmaceutical manufacturing QC laboratory or a contract pharmaceutical analytical testing laboratory, specifically pertaining to pharmaceutical dosage forms such as oral and liquid
• Strong preference for candidates with expertise in HPLC operation using Empower software, as well as proficiency in dissolution analysis.
• Must possess effective communication skills, both written and verbal.
• Must possess good technical and analytical skills to independently resolve or troubleshoot issues.

Additional Desired Preferences

Proficiency in leading projects to completion with a high level of scientific expertise, including extensive knowledge of pharmaceutical testing requirements and test protocols encompassing compendial methods (USP, BP, EP, etc.) and customer-specific methods, is highly desired. Preference will be given to candidates with expertise in GC operation using Empower software, as well as proficiency in ICP-OES, ICP-MS, and LC-MS, including troubleshooting capabilities. Additionally, candidates should be adept at operating and troubleshooting other analytical instruments, such as IR, KF, UV, ion chromatography, disintegration (DT), and performing wet chemical analyses. Exceptional communication and presentation skills, both verbal and written, are essential, with a preference for those experienced in the pharmaceutical industry. Familiarity with ICH guidelines and FDA regulations, along with experience in compendial procedures and compliance, is highly desirable. Proficiency in using an Electronic Laboratory Notebook (ELN) is also preferred. The ideal candidate demonstrates a personal commitment to delivering high-quality work on time and possesses the ability to anticipate, troubleshoot, and resolve technical challenges. Awareness of GLP regulations, QMS, ISO/IEC 17025, ISO 9001, and exposure to external regulatory audits is an added advantage.

Supervisory Responsibilities

No

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

Job Category

Chemistry & Scientific Standards

Job Type

Full-Time