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Scientist Iv, Reference Standards Evaluation

Usp
USP
6-10 years
Not Disclosed
Hyderabad
8 May 12, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Scientist III / Scientist IV – Reference Standards (Analytical Reference Materials)

Work Mode

Onsite / Laboratory-Based

Organization

United States Pharmacopeia (USP) (USP–India)


About USP

United States Pharmacopeia (USP) is a global scientific organization dedicated to developing trusted public standards that ensure the quality, safety, and efficacy of medicines worldwide. USP promotes scientific rigor, inclusive collaboration, and evidence-based decision-making to strengthen global public health systems and improve access to high-quality medicines.

For more information, visit: United States Pharmacopeia


Job Summary

We are seeking a Scientist III / Scientist IV to support the Reference Standards (RS) / Analytical Reference Materials (ARM) portfolio.

This is a hands-on, non-supervisory scientific role responsible for managing the lifecycle of reference standards, including analytical testing coordination, data review, protocol preparation, and collaboration with international laboratories.

The role ensures timely availability, quality, and scientific integrity of reference materials used globally in pharmaceutical analysis and quality control.


Key Responsibilities

Reference Standards Lifecycle Management

  • Manage end-to-end activities for reference standards (RS/ARMs/CRMs).

  • Oversee preparation and execution of testing protocols for new and replacement materials.

  • Ensure timely scheduling, documentation, and availability of reference materials.

Analytical Data Review & Reporting

  • Review analytical data from collaborating laboratories.

  • Prepare summary reports and technical evaluation documents.

  • Interpret and validate data from international collaborative studies.

  • Assign periodic re-test intervals for reference materials.

Laboratory Coordination & Technical Support

  • Provide technical support to collaborating laboratories.

  • Coordinate additional testing requirements when needed.

  • Assist internal teams in resolving technical queries and study-related issues.

Scientific Evaluation & Investigation

  • Interpret spectroscopic data (NMR, MS, IR) for compound characterization.

  • Support investigation of analytical or quality issues related to reference materials.

  • Propose and design studies to resolve technical or customer complaints.

Documentation & Quality Compliance

  • Prepare packaging instructions and QC testing documentation.

  • Ensure compliance with quality standards and internal procedures.

  • Maintain accurate and complete documentation for reference standards portfolio.

Cross-Functional Collaboration

  • Collaborate with Documentary Standard teams for monograph peer review.

  • Work with internal USP departments and external stakeholders.

  • Support cross-functional scientific initiatives across laboratories and operations.

Communication & Stakeholder Engagement

  • Communicate technical information to internal and external audiences.

  • Respond to customer technical inquiries with minimal supervision.

  • Investigate and resolve customer complaints related to reference materials.

  • Present scientific findings to USP staff and external stakeholders.

Additional Responsibilities

  • Participate in cross-functional projects and scientific initiatives.

  • Contribute to continuous improvement of reference standards processes.

  • Perform additional duties as assigned.


Required Qualifications

Education & Experience

Scientist IV

  • MSc in Chemistry or related field with 8–10 years experience
    OR

  • PhD in Chemistry or related field with 3–5 years experience

Scientist III

  • MSc in Chemistry or related field with 6–8 years experience
    OR

  • PhD in Chemistry or related field with 1–3 years experience


Required Skills & Competencies

Analytical & Technical Expertise

  • Strong knowledge of analytical chemistry and compound characterization.

  • Hands-on experience with spectroscopic techniques (NMR, MS, IR).

  • Experience with chromatographic techniques (HPLC, GC).

  • Ability to interpret complex analytical data.

Laboratory & Quality Systems

  • Experience with stability studies and lab investigations (preferred).

  • Understanding of quality systems and regulated laboratory environments.

  • Ability to handle multiple priorities in fast-paced environments.

Scientific & Problem-Solving Skills

  • Strong ability to troubleshoot analytical issues.

  • Capability to design and propose scientific studies.

  • Strong attention to detail and data accuracy.

Communication & Collaboration

  • Excellent written and verbal communication skills.

  • Ability to collaborate with internal teams and external laboratories.

  • Ability to present technical information clearly to diverse audiences.

Behavioral Competencies

  • Strong organizational and time management skills.

  • Ability to work independently with minimal supervision.

  • Strong accountability and ownership of deliverables.

  • Adaptability in a dynamic scientific environment.


Preferred Experience

  • Experience in materials characterization using multiple analytical techniques.

  • Exposure to regulatory or pharmacopeial environments.

  • Experience handling laboratory investigations and complaint resolution.


Working Environment

  • Laboratory-based scientific role with global collaboration.

  • Exposure to analytical testing, regulatory standards, and reference materials systems.

  • High focus on quality, compliance, and scientific accuracy.


Why Join USP

  • Contribute directly to global medicine quality through reference standards.

  • Work in a scientifically rigorous and internationally collaborative environment.

  • Engage in advanced analytical chemistry and method validation work.

  • Support public health by ensuring reliable pharmaceutical standards worldwide.

  • Be part of an inclusive organization focused on scientific excellence and equity.