Senior Scientist I, Compendial Development Laboratory

BioSpace

Indiana

Presencial

USD 120.000 - 180.000

Jornada completa

Hace 7 días
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Descripción de la vacante

USP seeks an experienced analytical scientist for the Compendial Development Laboratory, within Global Laboratory Operations. You will develop and validate analytical methods for USP/NF monographs, maintaining GLP environment and supporting monograph modernization initiatives.

In this role you will contribute to public health standards and engage with stakeholders across USP’s equity and inclusion initiatives, advancing scientific rigor and regulatory excellence.

Formación

  • Master’s or PhD in Chemistry or Pharmaceutical sciences with extensive laboratory experience.
  • Experience with GMP/GLP/QMS environments and data integrity.
  • Hands-on analytical method development and validation in pharma/food contexts.

Responsabilidades

  • Engage in project planning, method development and validation per USP guidelines.
  • Apply analytical expertise to small molecules and food projects.
  • Prepare and review project plans, reports and LMS datasets.
  • Ensure GLP and safety practices in the laboratory.
  • Promote Diversity, Equity, Inclusion and Belonging at USP India.

Educación

Master’s Degree in Chemistry or Pharmaceutical sciences
PhD in a relevant field

Herramientas

HPLC
UHPLC
LC–MS
GC
GC–MS
FT‑IR
UV‑Vis
KF

Descripción del empleo

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.


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.


Brief Job Overview

This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business, and the incumbent is expected to support monograph modernization initiatives.


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. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.


Responsibilities


  • [30 %] Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.

  • [30 %] Apply technical and scientific expertise in analytical method development and validation of Small molecules and Food projects.

  • [15 %] Prepare and review the project plans, reports, laboratory notebook / Laboratory management system (LMS) and compile project data as per requirement.

  • [15 %] Adhere to GLP and safety practices while working in the Lab.

  • [10 %] 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:


Note

As part of the recruitment process, USP's Global Talent Acquisition team may contact candidates through a variety of communication channels, including Microsoft Teams, telephone, email, and WhatsApp (voice calls and text messages). These communications may be used to schedule interviews, provide updates on application status, discuss career opportunities, and answer questions about employment with USP.


To help ensure timely communication, candidates are encouraged to keep their contact information current and to engage only with individuals who clearly identify themselves as authorized USP representatives. USP will never request payment, banking details, or other financial information as part of the hiring process.


Qualifications


  • Master’s Degree in Chemistry or Pharmaceutical sciences with 11-13 years of experience or PhD with at least 7-10 years of experience in relevant field..

  • Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices.

  • Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.

  • Should be capable of performing analytical method developments and method validations using modern techniques and protocols.

  • Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, FT-IR, UV-Visible and KF..

  • Should have fair understanding of GLP regulations and exposed to external regulatory audits.

  • Should possess strong technical knowledge in the areas of HP-TLC, sample extraction techniques.

  • Good analytical skills in handling method developments and validations for Food products and Food additives..

  • Awareness of ISO/IEC 17025 is desirable.


Additional Desired Preferences


  • Exceptional breadth of Pharma/Food industry experience.


Excellent Technical Writing And Oral Communication Skills Required.

Must be able to communicate effectively with diplomacy and enthusiasm.


Technical and analytical skills required including the ability to interpret technical information.


Supervisory Responsibilities

None


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 written agreement with USP.


Job Category Chemistry & Scientific Standards


Job Type Full-Time

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